Canadian Retrospective Observational Study of MVASI in metastatic Colorectal Cancer (20180360)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective chart review

Study drug and medical condition

• Name of medicine:
  MVASI
• Medical condition to be studied:
  Colorectal cancer metastatic

Population studied

• Short description of the study population:
  The study population included patients aged 18 years or older diagnosed with metastatic colorectal cancer treated with MVASI in Canada.; Inclusion criteria:; 1. Adult patients ≥ 18 years of age at the Index date (first dose of MVASI); 2. Metastatic CRC ie, confirmed histological or cytological adenocarcinoma of rectum or colon, stage 4; 3. Previously untreated patients who receive MVASI as a part of their initial (first line) treatment for metastatic CRC; 4. Patient has received at least 1 cycle of MVASI treatment as a part of their initial (first line) treatment for metastatic CRC; 5. Index date (first dose of MVASI) is at least 1 month prior to chart review date; ; Exclusion Criteria:; 1. Patient received an investigational product or participated in an investigational device or drug study at any time between 90 days pre-index date to 30 days post-last dose of MVASI; 2. Patient previously treated with bevacizumab for metastatic CRC, prior to Index Date (first dose of MVASI); 3. Patient is pregnant at any time during treatment with MVASI
• 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 colorectal cancer patients
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  To describe the safety of MVASI treatment by assessing the frequency of Events of Interest (EOIs), in first-line mCRC patients in Canada
• Outcomes:
  • Infusion reactions • Thromboembolic events • Gastrointestinal (GI) perforations • Hypertension • Hemorrhages • Wound-healing complications • Proteinuria • Ovarian Failure, Objective Response (RECIST criteria), Disease progression (if applicable)
• Data analysis plan:
  The analysis is entirely descriptive in nature with no hypothesis testing. Frequency estimation for each of the EOIs will be based on the number of patients who experience the events (at least one event per patient) divided by the total number of patients under observation. A frequency estimate for each EOI will also be provided by treatment cycle. Confidence intervals, 2-sided 95% will be provided. An additional frequency estimate of patients experiencing at least one instance of each EOI adjusted for duration of observation will also be provided