Trial · NCT01001377
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm. | months | MEDIAN |
| SECONDARY | Progression-free Survival | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Primary analysis set | months | MEDIAN |
| SECONDARY | Objective Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Tumor Response Analysis Set: Participants in the primary analysis set with at least 1 Baseline unidimensionally measurable lesion per RECIST version 1.1. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Participants with an objective response | months | MEDIAN |
| SECONDARY | Time to Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Participants with an objective response | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Primary analysis set | months | MEDIAN |
| SECONDARY | Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS) | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set participants with available data | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set participants with available data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in NCCN FCSI Physical Well-being Scale Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set participants with available data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in NCCN FCSI Functional Well-being Scale Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set participants with available data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks. | Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses. | 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/NCT01001377/outcomes