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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043605
Receipt No. R000049786
Scientific Title Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Date of disclosure of the study information 2021/03/15
Last modified on 2021/03/12

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Basic information
Public title Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Acronym Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Scientific Title Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Scientific Title:Acronym Adverse drug reaction and impact of it of pulmonary tuberculosis treatment.
Region
Japan

Condition
Condition pulmonary tuberculosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We mainly evaluate the difference of incidence of adverse drug reaction that requires discontinuation or change of medication by age and the discontinuation period.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of the incidence of adverse drug reaction that requires discontinuation or change of medication (dADR) by age among patients aged 50 or older.
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
22 years-old <=
Age-upper limit
98 years-old >=
Gender Male and Female
Key inclusion criteria Patients who started pulmonary tuberculosis treatment at our hospital from April 2018 to March 2020.
Key exclusion criteria None
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Kaki
Organization National Hospital Organization Wakayama Hospital
Division name Department of Respiratory Medicine
Zip code 644-0044
Address 1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
TEL 0738-22-3256
Email tk-3155kaki.xd7@nifty.com

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Kaki
Organization National Hospital Organization Wakayama Hospital
Division name Department of Respiratory Medicine
Zip code 644-0044
Address 1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
TEL 0738-22-3256
Homepage URL
Email tk-3155kaki.xd7@nifty.com

Sponsor
Institute National Hospital Organization Wakayama Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Hospital Organization Wakayama Hospital Ethics Committee
Address 1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
Tel 0738-22-3256
Email 419-kenkyubu@mail.hosp.go.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 03 Month 15 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 Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 15 Day
Date of IRB
2021 Year 03 Month 15 Day
Anticipated trial start date
2021 Year 03 Month 15 Day
Last follow-up date
2022 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A retrospective study was conducted based on medical records.

Management information
Registered date
2021 Year 03 Month 12 Day
Last modified on
2021 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049786

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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