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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)

ABSTRACT: 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.

DISEASE(S): Colorectal Neoplasms,Advanced Or Recurrent Colorectal Cancer

PROVIDER: 2162872 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Vectibix 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)

Project description:Interventions: investigational material(s) Generic name etc : Vectibix (panitumumab) for Intravenous Infusion 100 mg and 400 mg INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : The usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. The dosage may also be reduced as needed, depending on the patient s condition. Primary outcome(s): Frequency of adverse drug reactions Primary timeframe 42 weeks The frequency of adverse drug reactions will be tabulated by type, seriousness, time of onset, etc. Specifically, information will be collected on the development of the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders. Study Design: Postmarketing surveillance

| 97900 | ecrin-mdr-crc