N/A
Completed N=3,091
Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)
Advanced or Recurrent Colorectal Cancer
Source: ClinicalTrials.gov NCT02089737 ↗
Enrolled (actual)
3,091
Serious AEs
44.1%
Results posted
Apr 2017
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions — 2595; 2364; 771; 642 Participants
Summary
The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.
Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
2595; 2364; 771; 642; 552; 7 | — |
| SECONDARY Progression-free Survival |
3.5 | — |
| SECONDARY Overall Survival |
41 | — |
Eligibility Criteria
Inclusion Criteria
- Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
Exclusion Criteria
- Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix
Data sourced from ClinicalTrials.gov (NCT02089737). 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. Informational only — not medical advice.