18 and older, any sex, with ALK or ROS1-positive NSCLC. 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 Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03Primary· From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
An AE was any untoward medical occurrence in a clinical study participant associated with the use of study intervention, whether or not considered related to the study intervention. According to NCI CTCAE version 4.03: Grade 3 indicates severe AE, Grade 4 indicates life-threatening consequences and urgent intervention indicated and Grade 5 indicates death related to AE. Participants who discontinued treatment due to AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of de
Grade 3 or 4 AEs
Group
Value
95% CI
Crizotinib
19
Grade 5 AEs
Group
Value
95% CI
Crizotinib
2
AEs Leading to Treatment Discontinuation
Group
Value
95% CI
Crizotinib
4
SAEs
Group
Value
95% CI
Crizotinib
13
Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03Primary· From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
An AE was any untoward medical occurrence in a clinical study participant associated with use of study intervention, whether or not considered related to study intervention. AEs that were related to treatment were evaluated in this outcome measure. Treatment relatedness was judged by investigator. According to NCI CTCAE version 4.03: Grade 3= severe AE, Grade 4= life-threatening consequences and urgent intervention indicated, Grade 5= death related to AE. Participants who discontinued treatment due to treatment related AEs were captured under AEs leading to treatment discontinuation. SAE was a
Treatment Related Grade 3 or 4 AEs
Group
Value
95% CI
Crizotinib
11
Treatment Related Grade 5 AEs
Group
Value
95% CI
Crizotinib
0
Treatment Related AEs Leading to Treatment Discontinuation
Group
Value
95% CI
Crizotinib
1
Treatment Related SAEs
Group
Value
95% CI
Crizotinib
4
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Crizotinib
Serious: 13/41 (32%)
Deaths: 3/41
Serious adverse events (18 terms)
Reaction
System
Crizotinib
Disease progression
General disorders
—
Crohn's disease
Gastrointestinal disorders
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
Impaired gastric emptying
Gastrointestinal disorders
—
Obstruction gastric
Gastrointestinal disorders
—
Pancreatitis acute
Gastrointestinal disorders
—
Anal abscess
Infections and infestations
—
Herpes zoster
Infections and infestations
—
Pneumonia
Infections and infestations
—
Postoperative wound infection
Infections and infestations
—
Pyelonephritis chronic
Infections and infestations
—
Hypoalbuminaemia
Metabolism and nutrition disorders
—
Hypoproteinaemia
Metabolism and nutrition disorders
—
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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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: 8 November 2024
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/NCT03672643.