18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Drug ReactionsPrimary· 52 weeks
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.
ADR
Group
Value
95% CI
XALKORI Capsules (Crizotinib)
1858
Serious ADR
Group
Value
95% CI
XALKORI Capsules (Crizotinib)
518
Objective Response Rate (ORR) at 52 WeeksSecondary· 52 weeks
Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Group
Value
95% CI
XALKORI Capsules (Crizotinib)
66.5
64.2 – 68.8
Adverse events — posted to ClinicalTrials.gov
Time frame: 52 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
XALKORI Capsules (Crizotinib)
Serious: 777/2028 (38%)
Deaths: 436/2028
Serious adverse events (273 terms)
Reaction
System
XALKORI Capsules (Crizotin…
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
—
Hepatic function abnormal
Hepatobiliary disorders
—
Pneumonia
Infections and infestations
—
Vomiting
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
Neutrophil count decreased
Investigations
—
Aspartate aminotransferase increased
Investigations
—
Alanine aminotransferase increased
Investigations
—
Decreased appetite
Metabolism and nutrition disorders
—
Hepatotoxicity
Hepatobiliary disorders
—
Oesophagitis
Gastrointestinal disorders
—
Liver disorder
Hepatobiliary disorders
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Blood creatinine increased
Investigations
—
Renal abscess
Infections and infestations
—
Pneumonia bacterial
Infections and infestations
—
Pyrexia
General disorders
—
Neutropenia
Blood and lymphatic system disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
—
Cardiac failure
Cardiac disorders
—
Deep vein thrombosis
Vascular disorders
—
Electrocardiogram QT prolonged
Investigations
—
Other adverse events (486 terms — click to expand)
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 13 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01597258.