Trial · NCT01639001
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Based on IRR by Treatment Arm | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months) | The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From randomization to death or last date known as alive for those who were lost to follow-up or withdrew consent (assessed up to 64 months). | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Control at 12 Weeks Based on IRR | From randomization to Week 12 | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Percentage of participants | NUMBER |
| SECONDARY | Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months | From randomization to 1 year and from randomization to 18 months | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Percentage of paricipants | NUMBER |
| SECONDARY | Duration of Response (DR) Based on IRR | From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N = Participants with objective tumor response by IRR. | Weeks | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) Based on IRR | Randomization to first documentation of objective tumor response (up to 33 months). | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N=Participants who had objective tumor response by IRR. | Weeks | MEDIAN |
| SECONDARY | Time to Progression (TTP) Based on IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Intracranial Time to Progression (IC-TTP) Based on IRR | Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Extracranial Time to Progression (EC-TTP) Based on IRR | Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, or Cough Assessed Using Quality of Life Questionnaire Supplement Module for Lung Cancer (QLQ-LC13) | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment for pain in chest, dyspnea or cough. | Months | MEDIAN |
| SECONDARY | Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30 | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)-Visual Analog Scale (VAS) | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in General Health Status as Assessed by EQ-5D-Index | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months) | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Visual Disturbance as Assessed by Visual Symptom Assessment Questionnaire (VSAQ-ALK) | Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to Cycle 86) | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Percentage of participants | NUMBER |
| SECONDARY | Agreement Between Central Laboratory ALK FISH and ALK IHC Test Results - Molecular Profiling Evaluable | During the screening (less than or equal to 28 days prior to dosing) | The MP evaluable population included 812 participants, of which there were 771 participants that had a test result (positive or negative) from both the FISH test and the IHC test. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities) | From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks) | All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-Emergent AEs (Treatment Related) | From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks) | All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received. | Percentage of participants | NUMBER |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01639001/outcomes