A Prospective Post-Marketing Observational Safety Study of Cyramza® (Ramucirumab) in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma in China (I4T-MC-B012)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RAMUCIRUMAB
• Medical condition to be studied:
  Gastric cancer

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  854

Study design details

• Main study objective:
  To describe the safety and effectiveness of Cyramza in adult patients with gastric or gastroesophageal junction adenocarcinoma.
• Outcomes:
  To describe the safety profile of Cyramza administered for treatment of adult patients with gastric or GEJ adenocarcinoma under real-world disease conditions in China. To describe the effectiveness of Cyramza administered for treatment of adult patients with gastric or GEJ adenocarcinoma under real-world disease conditions in China.
• Data analysis plan:
  A descriptive analysis will be conducted to describe the safety and effectiveness of Cyramza. Regardless of the relatedness to Cyramza, the incidence of AEs and SAEs will be summarized. PFS and OS will be summarized as median with their 95% CIs using the Kaplan-Meier method. ORR and DCR will be summarized as percentages and 95% CI.