N/A
Completed N=191
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)
Source: ClinicalTrials.gov NCT01697449 ↗Enrolled (actual)
191
Serious AEs
12.0%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With At Least One Adverse Event (AE) — 15.2 percentage of participants
Summary
This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With At Least One Adverse Event (AE) |
15.2 | — |
| SECONDARY Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST) |
72; 69 | — |
| SECONDARY Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline |
34.5 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death |
76.5 | — |
| SECONDARY Progression Free Survival (PFS) |
9 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Metastatic colorectal cancer
- Prescribed to receive Avastin according to registered indication
Exclusion Criteria
- Patients not eligible for Avastin treatment according to the Summary of Product Characteristics
Data sourced from ClinicalTrials.gov (NCT01697449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.