N/A
N=1,674
Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)
Carcinoma, Renal Cell
Bottom Line
View on ClinicalTrials.gov: NCT00716625 ↗Enrolled (actual)
1,674
Serious AEs
59.8%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events — 1599 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- sunitinib malate (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
1599 | — |
| PRIMARY Objective Response Rate |
21.9 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events in Pediatric Population |
1; 1581; 17 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events in Elderly Population |
688; 894; 17 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment |
154; 1441; 4 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment |
336; 1260; 3 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors |
82; 45; 1472 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment |
4 | — |
| SECONDARY Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation |
19; 1294; 287; 61; 6; 313 | — |
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 (NCT00716625). 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.