UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045443 |
|---|---|
| Receipt number | R000051852 |
| Scientific Title | Signal detection of pediatric adverse drug reaction using electronic medical record |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2023/09/14 13:47:28 |
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Basic information
Public title
Signal detection of pediatric adverse drug reaction using electronic medical record
Acronym
Signal detection of pediatric adverse drug reaction using electronic medical record
Scientific Title
Signal detection of pediatric adverse drug reaction using electronic medical record
Scientific Title:Acronym
Signal detection of pediatric adverse drug reaction using electronic medical record
Region
| Japan |
Condition
Condition
Children who experienced drug prescription and laboratory test
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create a model to predict the association between drug and adverse event in pediatrics using electronic medical record.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluctuations in platelet and serum creatinine levels associated with drug administration
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Received a prescription for a drug between January 2010 and December 2018
(2) A platelet or serum creatinine sample test was performed.
Key exclusion criteria
Patients who are prescribed only medicines that are classified as vitamins, tonic, blood substitutes, preparations, public health medicines, or in vitro diagnostic medicines.
Target sample size
54000
Research contact person
Name of lead principal investigator
| 1st name | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biostatistics
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-Ku, Sendai-shi, Miyagi
TEL
022-717-7659
yamaguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shih-Wei |
| Middle name | |
| Last name | Chiu |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biostatistics
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-Ku, Sendai-shi, Miyagi
TEL
022-717-7659
Homepage URL
chiu@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-machi, Aoba-Ku, Sendai-shi, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
| 2021 | Year | 09 | Month | 10 | 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
4641
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
| 2019 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For all pediatric patients who meet the eligibility criteria among the cases included in the electronic medical record database, the clinical laboratory values (platelet count and serum creatinine) before and after the administration of the drug will be tabulated, and the variations will be calculated. A model will then be developed to comprehensively detect and prioritize drugs that may be associated with thrombocytopenia and renal impairment in children.
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051852
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
