UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019274 |
|---|---|
| Receipt number | 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 | 2022/10/17 15:50:13 |
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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
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
sugizaki@foodallergy.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
