Study type

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

AVASTIN

Medical condition to be studied

Colorectal cancer
Non-small cell lung cancer
Population studied

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)

Estimated number of subjects

4000
Study design details

Main study objective

This is an observational study designed to evaluate the effectiveness and safety of patients with metastatic or locally advanced and unresectable CRC, locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in combination with first-line chemotherapy. Second-line metastatic CRC patients are also eligible.

Outcomes

Effectiveness outcome measures (which include progression-free survival, response rate, overall survival)Safety outcome measures

Data analysis plan

Patient demographics and baseline characteristics will be described using summary statistics. Effectiveness and safety outcomes will be summarized overall (safety only), by tumor type (CRC and NSCLC), and by class of chemotherapy.The effectiveness analyses for each indication will include Kaplan-Meier estimates of median PFS and overall survival (OS) and presented with 95% confidence intervals (CIs). Multivariable Cox proportional hazard regression models, adjusting for baseline covariates will also be performed. For CRC patients, PFS will be summarized separately for first-line and second-line patients.For safety analyses, descriptive summaries on protocol-specified BV-associated adverse events (AEs) over the entire follow-up will be presented. Incidence proportions and their exact 95% confidence intervals will be reported.