Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Healthcare resource utilisation

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Colorectal cancer metastatic
Population studied

Short description of the study population

Subjects with wild-type RAS metastatic colorectal cancer CRC treated with Vectibix® according to the SmPC in France and Germany.

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

Colorectal cancer patients

Estimated number of subjects

740
Study design details

Main study objective

Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC (12mo)

Outcomes

Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC (12mo), Healthcare resource utilization (12mo)Demography of disease population (12mo)Response to Vectibix® (12mo)Planned anti-cancer treatment initiated post Vectibix (12 mo)

Data analysis plan

The analysis of this study will be descriptive in nature. The data will be summarized for patients with metastatic colorectal cancer (mCRC) with tumour expressing wild type (non-mutated) KRAS who received Vectibix® in combination with FOLFOX as first-line treatment and subjects who received Vectibix® in combination with FOLFIRI as second line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). The data will be summarized by country to fulfil local post reimbursement requirements. For continuous outcomes, the mean, standard deviation, median, and range will be provided. For categorical variables, the frequency and percentage, with two-sided 95% CI, will be displayed for the treatment pattern of Vectibix®. Summary tables and analyses will be based on FLFAS and SLFAS and corresponding local tumour response analysis sets. Summary statistics will be reported for the significant covariates.Selected sensitivity analyses may be performed.
Documents
Study results
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