Health Condition 1: null- NSCLC (Non Small Cell Lung Cancer)
Conditions
Interventions
Intervention1: Nintedanib: This is not an interventional study but this is an active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally
Sponsors
Boehringer Ingelheim India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients =18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after relapse or failure of first line of chemotherapy who are newly prescribed nintedanib according to the package insert. 2. Willing to provide the informed consent 3. Patients in whom further visit/contact is possible during the planned period of active surveillance 4. Patients in whom information mentioned in the section 9.2.2.2 of the protocol is available
Exclusion criteria
Exclusion criteria: 1. Patients who have taken nintedanib before participation in the study 2. Patients who are positive for EGFR mutation 3. Patients who are positive for ALK rearrangements 4. Patients who are participating in a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Occurrence of ADRs (serious and non-serious) 2. Occurrence of AEs (serious and fatal)Timepoint: 2 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse eventsTimepoint: 2 Years | — |
Countries
India
Contacts
Public ContactDr Rajesh Naik
Boehringer Ingelheim India Pvt. Ltd.
Outcome results
None listed