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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019274
Receipt No. R000022287
Scientific Title The analysis of drug-related anaphylactic cases by using PMDA database
Date of disclosure of the study information 2015/10/08
Last modified on 2018/10/10

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Basic information
Public title The analysis of drug-related anaphylactic cases by using PMDA database
Acronym Analysis of anaphylactic cases from PMDA database
(PMDA-An analysis)
Scientific Title The analysis of drug-related anaphylactic cases by using PMDA database
Scientific Title:Acronym Analysis of anaphylactic cases from PMDA database
(PMDA-An analysis)
Region
Japan

Condition
Condition Anaphylaxis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify mainstay drugs and drugs with high mortality rate in drug-related anaphylaxis cases
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To clarify an outline of drug related anaphylaxis cases in Japan
Key secondary outcomes

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 Cases that were suspected as adverse reaction of drugs and reported to PMDA
Key exclusion criteria None
Target sample size 15000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Ebisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email mebisawa@foodallergy.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chizuko Sugizaki
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Homepage URL
Email sugizaki@foodallergy.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Japanese Society of Allergology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立病院機構相模原病院(神奈川県)Sagamihara National Hosital

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 08 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 No longer recruiting
Date of protocol fixation
2015 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: retrospective cohort study
Subjects: Cases that were suspected as adverse reaction of drugs and reported to PMDA from April 2004 to December 2014
Analyzing items: Number of cases of each year, therapeutic category, product, route of administration etc.

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022287

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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