Trial · NCT00680901
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival at the Time of Primary Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) | Primary Efficacy (PE) population | Months | MEDIAN |
| PRIMARY | Overall Survival in All Randomized Participants at the Time of Primary Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) | Intent-to-Treat (ITT) Population | Months | MEDIAN |
| SECONDARY | Overall Survival at the Time of Final Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From date of randomization till the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population | Months | MEDIAN |
| SECONDARY | Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR) | From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinical Benefit (CB) | From date of randomization till date of disease progression (PD) or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response (TTR) | From date of randomization till the first documented evidence of confirmed CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population. Only those participants who had a confirmed CR or PR were analyzed for time to response. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population. Only those participants who had a confirmed CR or PR were analyzed for duration of response. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Any On-therapy Adverse Event (AE) and Serious Adverse Event (SAE) | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With On-therapy Adverse Event (AE) by Maximum Grade | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Safety population. Only participants with On-therapy AEs | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With On-therapy Serious Adverse Event (SAE) by Maximum Grade | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Safety population. Only participants with on-therapy Serious Adverse Events (SAEs) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Domain Scores | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population. Only those participants contributing data at the indicated time point were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) Scales/Items Score Scale | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population. Only those participants contributing data at the indicated time point were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Utility Score (Health Utility Index) in the EuroQoL-5 Dimensions (EQ-5D) Questionnaire | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population. Only those participants contributing data at the indicated time point were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Thermometer Score (EQ VAS) in the EuroQoL-5 Dimensions (EQ-5D) Questionnaire | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population. Only those participants contributing data at the indicated time point were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Percentage of Participants With Worst-case On-therapy Chemistry Toxicities | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Safety Population. Only those participants contributing data at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Worst-case On-therapy Hematologic Toxicities | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Safety Population. Only those participants contributing data at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00680901/outcomes