UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014989 |
|---|---|
| Receipt number | R000017439 |
| Scientific Title | ALECENSA Drug Use Surveillance |
| Date of disclosure of the study information | 2014/09/05 |
| Last modified on | 2017/09/06 11:16:00 |
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Basic information
Public title
ALECENSA Drug Use Surveillance
Acronym
ALECENSA Drug Use Surveillance
Scientific Title
ALECENSA Drug Use Surveillance
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Joji Mochizuki |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Pharmacovigilance Dept.
Zip code
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3273-0905
mochizukijuj@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayaka Shimizu |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Real World Data Science Dept.
Zip code
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3273-0905
Homepage URL
shimizuayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 04 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017439
