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Talimogene laherparepvec

Amgen Call Center

A postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up to 5 years after the first IMLYGIC dose.

Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection

A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® in Clinical Practice to Characterize Risk of Herpetic Infection Among Patients, Close Contacts, Health Care Providers & Long-term Safety in Treated Patients

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec (T-VEC) DNA among patients for up to 5 years after the first IMLYGIC dose.

Count the number of herpetic infections with detection of T-VEC DNA among close contacts and HCPs.

Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients during treatment with IMLYGIC.

Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients after discontinuation of IMLYGIC.

Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients during treatment with IMLYGIC.

Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients after discontinuation of IMLYGIC.

The following baseline variables will be recorded: sex, age, Eastern Cooperative Oncology Group (ECOG) performance status.

Describe the use of IMLYGIC, other anti-cancer therapy, anti-herpetic therapy.

Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC

Survival is defined by the time to death from the date of the first use of IMLYGIC.

Spots Global Cancer Trial Database for herpetic infection