Special Investigation For Gist Of Sutent (Regulatory Post Marketing Commitment Plan).
Phase 4
N/A
N/A
N/A
N/A
Open (Enrolling by invite only)
Both
Gastrointestinal Stromal Tumors
Both
Gastrointestinal Stromal Tumors
Trial Information
Special Investigation For Gist Of Sutent (Regulatory Post Marketing Commitment Plan).
All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should
be registered.
Inclusion Criteria:
Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the
surveillance.
Exclusion Criteria:
Patients not administered SUNITINIB MALATE(Sutent).
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Institutional Review Board
Study ID:
A6181175
NCT ID:
NCT00716820
Start Date:
May 2008
Completion Date:
April 2014
Related Keywords:
- Gastrointestinal Stromal Tumors
- Gastrointestinal Stromal Tumors
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