Trial · NCT01945021
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Independent Radiology Reviewed Overall Objective Response (ORR) | Starting from the first dose study treatment until the first documented CR or PR (every 8 weeks then after 8 cycles at every 12 weeks in duration of 94.0 weeks) | The response-evaluable population (RES) population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | IRR-Assessed Duration of Response (DR) | From first documentation of objective tumor response to first documentation of objective PD or death due to any cause, whichever occurred first (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | The RES population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. Here, Overall Number of Participants Analyzed signifies number of participants with a confirmed objective response that could have occurred anytime up to 151.3 weeks. | Months | MEDIAN |
| SECONDARY | IRR-Assessed Time to Tumor Response (TTR) | From date of first dose of crizotinib to first documentation of objective response was observed (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | The RES population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. Here, Overall Number of Participants Analyzed signifies number of participants with a confirmed objective response that could have occurred anytime up to 151.3 weeks. | Months | MEDIAN |
| SECONDARY | IRR Assessed Disease Control Rate (DCR) at 8 Weeks | At 8 weeks after the start of study treatment | The RES population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. | Percentage of participants | NUMBER |
| SECONDARY | IRR-Assessed Progression Free Survival (PFS) | From the date of first dose of crizotinib until the first documentation of objective PD or death (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | The safety analysis population (SAF) included all enrolled participants who received at least 1 dose of study medication. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From date of the first dose of crizotinib until the date of death from any cause (up to 291.9 weeks) | SAF included all enrolled participants who received at least 1 dose of study medication. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | SAF included all enrolled participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Shift in Hematology Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4 | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | SAF included all enrolled participants who received at least 1 dose of study medication. Here, number analyzed signifies participants evaluable at specific rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Shift of Chemistry Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4 | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | SAF included all enrolled participants who received at least one dose of study medication. Here, number analyzed signifies participants evaluable at specific rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Scores | Baseline up to Cycle 60 | Patient reported outcome (PRO)-evaluable population (PRO) included enrolled participants who received at least 1 dose of study medication and completed the assessments at baseline and with at least 1 post-baseline time point. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 Scores | Baseline up to Cycle 60 | PRO evaluable population included participants from the safety analysis population who completed the assessments at baseline and at least one post-baseline time point. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Units on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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