Trial Information

Case Analysis on Real Life Incidence of PDT Safety Outcomes: Multicentre, Observational Post-marketing Safety Surveillance Registry of Patients Exposed to Photodynamic Therapy With Porfimer Sodium: The CALIPSO Registry

Patients will be enrolled in the registry upon injection of the porfimer sodium. During
normal medical examination, criteria for entry onto the registry will be verified to confirm
eligibility, and medical procedures including demographic information, disease history,
medical history, physical exam, and clinical laboratory testing performed under normal
practice will be collected. Patients will receive PDT as per current practice and will be
repeated as per the physician's judgment. All patients will be assessed as per current
practice, that is usually at least three times, after a PDT session. Additional visits will
be sought for those patients who are presenting photosensitivity reaction, esophageal
stenosis, perforation at the site of laser light application, or any unresolved serious
adverse reactions at the third visit after treatment. All patients will be requested by
their physician to complete a two-part Daily Diary to record adverse reactions using a
check-list form and a general section for reporting any adverse events and intake of
concomitant medications at the time of the adverse event.