Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Effectiveness study (incl. comparative)
Safety study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

YERVOY

Medical condition to be studied

Metastatic malignant melanoma
Population studied

Short description of the study population

Patients diagnosed with unresectable or metastatic melanoma.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Metastatic malignant melanoma patients

Estimated number of subjects

1800
Study design details

Main study objective

1) To estimate the incidence and severity of adverse reactions in adult patients treated withipilimumab in the post-approval setting2) To describe the management of adverse reactions and their outcomes inipilimumab-treated patients in the post-approval setting

Outcomes

- Incidence rate with person-year-exposure, frequency estimate of AE/SAE- Frequency at which immunosuppressive therapy was administered to manage treatment-related ARs associated with ipilimumab- Descriptive statistics to assess patterns of care: treatment, dosing, regimen, indication, treatment rationales, management of treatment-related AE, reasons for treatment discontinuation, - Resource utilization associated with advanced melanoma treatment: descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs

Data analysis plan

Descriptive data will be provided for treatment-related ARs that occur in the study population, frequency data for these ARs will be reported in aggregate. The incidence rate of all ARs among patients receiving ipilimumab will be determined (N/100 patient years) and a 95% CI will be provided. Incidence will be reported both cumulatively and by year since initiation of treatment. In addition, descriptive statistics will be provided for data regarding the management and outcome of ARs associated with use of ipilimumab. Descriptive statistics and multivariate logistic regression will be used to analyze patterns of care. Descriptivestatistics will also be reported to evaluate healthcare utilization and costs, and analysis of covariance will also be used for patient reported outcomes regarding quality of life. Overall survival and PFS probabilities will be estimated using Kaplan-Meier (KM) method, with medians and corresponding two-sided 95% confidence intervals.