ID
32153
Beschrijving
This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia
Trefwoorden
Versies (4)
- 21-10-18 21-10-18 -
- 28-10-18 28-10-18 -
- 30-10-18 30-10-18 -
- 31-10-18 31-10-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
21 oktober 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Study Conclusion, Pregnancy Information and Investigator Comment Log
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschrijving
Date of subject completion or withdrawal
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [2]
- C1549507
Beschrijving
Time of withdrawal
Datatype
time
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0040223
Beschrijving
INVESTIGATOR INSTRUCTIONS • Refer to protocol section(s) 11to evaluate subject completion or withdrawal from the study. • If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. • If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. • If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports. MONITOR DATA VALIDATION CHECKS • If the investigational product was discontinued at the same time as the subject was withdrawn from the study, ensure the reasons for the two discontinuations are consistent.
Datatype
text
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
• If the subject was withdrawn due to an adverse event, confirm that details recorded correspond with details on the Adverse Event: • ’Withdrawal’ on the AE/SAE page is recorded as ’Yes’. • ’Action Taken with Investigational Product(s) as a Result of the Non-Serious AE/SAE’ on the AE/SAE page is recorded as ’Investigational Product Withdrawn’. • ’Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Beschrijving
Other reason for withdrawal, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Beschrijving
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Beschrijving
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator's Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator's name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator's signature: Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Study Conclusion, Pregnancy Information and Investigator Comment Log
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C1516308 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])