Clinical trial · Observational
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
SPECIAL INVESTIGATION OF XALKORI FOR NSCLC (REGULATORY POST MARKETING COMMITMENT PLAN)
NCT01597258CI-TRIAL-00040594completedResults postedClinicalTrials.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)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crizotinib (Xalkori) | Drug | Crizotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Crizotinib (Xalkori)
- interventionNames
- Drug: Crizotinib (Xalkori)
Primary outcomes (1)
- measure
- Number of Participants With Adverse Drug Reactions
- timeFrame
- 52 weeks
- description
- An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician.
Secondary outcomes (1)
- measure
- Objective Response Rate (ORR) at 52 Weeks
- timeFrame
- 52 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.) Exclusion Criteria: * Patients not administered XALKORI in spite of enrolled.
References
Publications (1)
- DERIVEDUeno N, Banno S, Endo Y, Tamura M, Sugaya K, Hashigaki S, Ohki E, Yoshimura A, Gemma A. Treatment status and safety of crizotinib in 2028 Japanese patients with ALK-positive NSCLC in clinical settings. Jpn J Clin Oncol. 2019 Jul 1;49(7):676-686. doi: 10.1093/jjco/hyz049. PMID 31008509