Trial · NCT03672643
Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
NCT03672643, Phase 4, Terminated, Pfizer; results first posted 2024-11-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long Term Safety Observation of Crizotinib in Chinese NSCLC Population. Trials, record NCT03672643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03672643
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
- NCT number
- NCT03672643
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 41 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- ALK or ROS1-positive NSCLC
- Interventions
- Crizotinib
- First posted
- 2018-09-14
- Last updated
- 2024-11-08
- Results first posted
- 2024-11-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) v4.03 | 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 death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event. |
| Primary | 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 v4.03 | 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 any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) v4.03 | 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) | Safety analysis set included all participants who received at least one dose of the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 v4.03 | 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) | Safety analysis set included all participants who received at least one dose of the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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) v4.03 | Crizotinib | Grade 3 or 4 AEs | 19 | Participants | |
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) v4.03 | Crizotinib | Grade 5 AEs | 2 | Participants | |
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) v4.03 | Crizotinib | AEs Leading to Treatment Discontinuation | 4 | Participants | |
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) v4.03 | Crizotinib | SAEs | 13 | Participants | |
| 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 v4.03 | Crizotinib | Treatment Related Grade 3 or 4 AEs | 11 | Participants | |
| 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 v4.03 | Crizotinib | Treatment Related Grade 5 AEs | 0 | Participants | |
| 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 v4.03 | Crizotinib | Treatment Related AEs Leading to Treatment Discontinuation | 1 | Participants | |
| 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 v4.03 | Crizotinib | Treatment Related SAEs | 4 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crizotinib | 41 | |
| Overall Study | COMPLETED | Crizotinib | 0 | |
| Overall Study | NOT COMPLETED | Crizotinib | 41 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutrophil count decreased | Investigations | Crizotinib | 8 | 41 | |
| other | White blood cell count decreased | Investigations | Crizotinib | 3 | 41 | |
| serious | Crohn's disease | Gastrointestinal disorders | Crizotinib | 1 | 41 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Crizotinib | 1 | 41 | |
| serious | Impaired gastric emptying | Gastrointestinal disorders | Crizotinib | 1 | 41 | |
| serious | Obstruction gastric | Gastrointestinal disorders | Crizotinib | 1 | 41 | |
| serious | Pancreatitis acute | Gastrointestinal disorders | Crizotinib | 1 | 41 | |
| serious | Disease progression | General disorders | Crizotinib | 2 | 41 | |
| serious | Anal abscess | Infections and infestations | Crizotinib | 1 | 41 | |
| serious | Herpes zoster | Infections and infestations | Crizotinib | 1 | 41 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crizotinib | 3 | 41 |
| Total, other adverse events | Crizotinib | 8 | 41 |
| Total, serious adverse events | Crizotinib | 13 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03672643
GET https://conductscience.org/api/trials/v1/NCT03672643/registered