UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	ALECENSA Drug Use Surveillance
Title of the study (Brief title)	ALECENSA Drug Use Surveillance
Region	Japan

Condition
Condition	Lung Cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety; To detect unexpected adverse drug reactions (ADRs), to understand incidence of ADRs such as interstitial lung disease and hepatic function disorder, and to search for factors that affect ADR onset in postmarketing use. Efficacy; Tabulation of patient outcomes (survival/death), calculation of one-year survival rate
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety; ADR occurrence
Key secondary outcomes	Efficacy; Tabulation of patient outcomes (survival/death), calculation of one-year survival rate

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients who are scheduled to receive ALECENSA at contracted institutions during this surveillance's enrollment period.
Key exclusion criteria	No criteria
Target sample size	1000

Research contact person
Name of lead principal investigator	Joji Mochizuki
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Pharmacovigilance Dept.
Address	1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL	03-3273-0905
Email	mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person	Ayaka Shimizu
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Real World Data Science Dept.
Address	1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL	03-3273-0905
Homepage URL
Email	shimizuayk@chugai-pharm.co.jp

Sponsor
Institute	Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 04 Day
Anticipated trial start date	2014 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Patent baseline characteristics, Treatment history of primary disease, Concomitant drugs, Combination therapy, Outcome, AE

Management information
Registered date	2014 Year 08 Month 29 Day
Last modified on	2017 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017439