Advanced or recurrent cervical cancer that has progressed after cancer chemotherapy
Conditions
Interventions
None listed
Sponsors
Genmab K.K. Drug safety and pharmacovigilance
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients who received Tivdak for advanced or recurrent cervical cancer that has progressed after cancer chemotherapy, which is the indication of this drug, will be included. High-risk population: Patients with 'Ocular disease, etc.' * Low-risk population: Patients without 'Ocular disease, etc.' * *Active ocular surface disease, History or predisposition for Cicatricial conjunctivitis, or Stevens-Johnson syndrome with ocular signs and symptoms
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidences of eye disorders in the presence and absence of 'Ocular disease, etc.' will be tabulated, and the risk ratio of eye disorders in the presence and absence of 'Ocular disease, etc.' will be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1: The status of eye care to reduce eye disorders will be tabulated. 2: Tumor response at the best overall response based on RECIST version 1.1 will be tabulated. | — |
Contacts
Public ContactDrug safety and pharmacovigilance Genmab K.K.
Genmab K.K.
Outcome results
None listed