N/A
Completed N=28
Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy
Source: ClinicalTrials.gov NCT03017885 ↗Enrolled (actual)
28
Serious AEs
39.1%
Results posted
Mar 2024
Primary outcomePrimary: Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients — 17.9 Patients per 100 patient years
Summary
This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017). The objective is to look at the safety of nintedanib in the real world setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients |
17.9 | — |
| PRIMARY Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients |
25.3 | — |
| SECONDARY Percentage of Patients Who Required Nintedanib Dose Reductions |
4.3 | — |
| SECONDARY Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after first line chemotherapy who have initiated or will initiate nintedanib & docetaxel according to the package insert after the commercial availability of drug in India (23rd January 2017).
- Patients in whom it is possible to obtain voluntary informed consent from either the patient or patient's legally authorised representative (applicable for Group B and C patients).
- Patients in whom data collection is possible from the medical records (applicable for Group A and B patients).
- Further inclusion criteria apply.
Exclusion Criteria
- Patients who were previously treated with nintedanib.
- Patients who are positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements
- Patients who are participating in a clinical trial.
- Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT03017885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.