N/A
N=472
Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
Gastrointestinal Stromal Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00716820 ↗Enrolled (actual)
472
Serious AEs
54.9%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events — 450 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SUNITINIB MALATE (Drug)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
450 | — |
| PRIMARY Objective Response Rate |
20.1 | — |
| SECONDARY Objective Response Rates by KIT Expression Status |
21.2; 12.5; 11.9 | — |
| SECONDARY Objective Response Rates by c-Kit Mutation Status |
22.1; 20.0; 19.5 | — |
| SECONDARY Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status |
20.0; 27.8; 19.3 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events in Elderly Population |
220; 226; 4 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment |
52; 394; 4 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment |
47; 400; 3 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors |
12; 12; 426 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment |
3 | — |
| SECONDARY Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation |
1; 386; 106; 29; 1; 53 | — |
Summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00716820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.