UMIN-CTR Clinical Trial

Basic information
Public title	Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Acronym	Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Scientific Title	Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Scientific Title:Acronym	Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Region	Japan Asia(except Japan) North America South America Australia Europe Africa

Condition
Condition	tumors
Classification by specialty	Pneumology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	category fo adverse event
Key secondary outcomes	frequency of adverse event

Base
Study type	Others,meta-analysis etc

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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	treated with dabrafenib and trametinib
Key exclusion criteria	Without frequency or category of adverse event
Target sample size

Research contact person
Name of lead principal investigator	1st name Kou Middle name Last name Chin
Organization	Yokohama city university
Division name	pulmonology
Zip code	2360004
Address	3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
TEL	045-352-7962
Email	chinksmd@yahoo.co.jp

Public contact
Name of contact person	1st name Kou Middle name Last name Chin
Organization	Yokohama city university
Division name	Pulomonology
Zip code	2360004
Address	3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
TEL	045-352-7962
Homepage URL
Email	chinksmd@yahoo.co.jp

Sponsor
Institute	3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
Institute
Department

Funding Source
Organization	3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Yokohama city university
Address	3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
Tel	045-352-7962
Email	chinksmd@yahoo.co.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	2020 Year 08 Month 18 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	Terminated
Date of protocol fixation	2020 Year 08 Month 18 Day
Date of IRB	2020 Year 08 Month 18 Day
Anticipated trial start date	2020 Year 08 Month 18 Day
Last follow-up date	2020 Year 08 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 08 Month 18 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047322