UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	16916
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 05 Month 14 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 21 Day
Date of IRB	2015 Year 04 Month 21 Day
Anticipated trial start date	2015 Year 04 Month 21 Day
Last follow-up date	2021 Year 12 Month 31 Day
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 February 2018 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	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022287