Clinical trial · Observational
Regulatory Post Marketing Surveillance Study on Nexavar®
NCT01012011CI-TRIAL-00019161completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
Primary outcomes (1)
- measure
- Adverse events collection
- timeFrame
- From start of treatment to 4 weeks after discontinuation of treatment
Secondary outcomes (3)
- measure
- Duration of treatment, dosage and indication
- timeFrame
- Whole treatment period
- measure
- Tumor status
- timeFrame
- Whole treatment period
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 91 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar. Exclusion Criteria: * Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.