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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02239237 |
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Date of registration:
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10/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
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Scientific title:
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Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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30283 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02239237 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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China
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Contacts
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Name:
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Zhan-Yu Pan, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tianjin medical university cancer institute & hosptial |
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Name:
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Zhong Wang, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who use Compound Kushen Injection in the monitoring hospitals
Exclusion Criteria:
- None
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Severe Adverse Reactions
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Safety Surveillance
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Severe Adverse Events
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Adverse Drug Reactions
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Adverse Drug Events
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Intervention(s)
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Drug: Compound Kuh-seng Injection
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Primary Outcome(s)
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The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection
[Time Frame: 2 years]
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Secondary Outcome(s)
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The incidence of anaphylactic reaction to Compound Kuh-seng Injection
[Time Frame: 2 years]
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The incidence of new ADRs to Compound Kuh-seng Injection
[Time Frame: 2 years]
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The incidence of new SARs to Compound Kuh-seng Injection
[Time Frame: 2 years]
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The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection
[Time Frame: 2 years]
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Secondary ID(s)
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Kuh-seng1.0
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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