N/A
Completed N=258
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)
Source: ClinicalTrials.gov NCT01697462 ↗Enrolled (actual)
258
Serious AEs
4.3%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) — 132; 11 Participants
Summary
This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) |
132; 11 | — |
| SECONDARY Percentage of Participants With Disease Progression |
70.8 | — |
| SECONDARY Progression-Free Survival (PFS) |
4 | — |
| SECONDARY Number of Participants With Hand-Foot Syndrome (HFS) |
79 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Metastatic colorectal cancer
- Receiving Xeloda according to registered indication
Exclusion Criteria
- Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics
Data sourced from ClinicalTrials.gov (NCT01697462). 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.