Upper Gastrointestinal Cancer
Conditions
Brief summary
The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant nivolumab.
Interventions
DRUGNivolumab
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled in Bristol-Myers Squibb GastroEsophageal Opdivo in Resected Patients with Residual Pathological Disease Patient Support Program (GEORge PSP) in Canada * Patients who have consented to the use of their de-identified data generated from information collected in the course of the GEORge PSP
Exclusion criteria
* Aged \<18 years * Did not receive concurrent chemoradiotherapy prior to surgery * Positive margins following resection * No residual disease following complete resection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant histology results | Baseline |
| Participant comorbidities | Baseline |
| Participant tumour location | Baseline |
| Date of tumour resection | Baseline |
| Participant primary upper gastrointestinal cancer diagnosis | Baseline |
| Participant sociodemographics | Baseline |
| Participant Eastern Cooperative Oncology Group (ECOG) score | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Initial nivolumab dosage prescribed to participants | Index date |
| Number of nivolumab treatments received | Up to 484 days |
| Nivolumab dosage modification | Up to 484 days |
| Nivolumab treatment duration | Up to 484 days |
| Reason for participant discharge | Up to 484 days |
| Participant adverse events (AEs) | Up to 484 days |
| Management of participant adverse events (AEs) | Up to 484 days |
Countries
Canada
Outcome results
None listed