Trial · NCT01955837
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（OS） | Every 8 weeks. Survival status should be collected for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met, whichever is later. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Every 8 weeks. Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | Months | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF) | From randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 30 months. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR; Complete Response [CR] or Partial Response [PR] Using RECIST Criteria) | From randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 30 months. | The tumor response evaluable (TR) population: the TR population included all patients in the ITT population who had measurable disease (at least 1 target lesion) at baseline and with at least 1 tumor evaluation while on treatment. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR; CR, PR, or Stable Disease) | From randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 30 months. | The tumor response evaluable (TR) population: the TR population included all patients in the ITT population who had measurable disease (at least 1 target lesion) at baseline and with at least 1 tumor evaluation while on treatment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From randomization until the date of radiologic disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 30 months. | The tumor response evaluable (TR) population: the TR population included all patients in the ITT population who had measurable disease (at least 1 target lesion) at baseline and with at least 1 tumor evaluation while on treatment. | Months | MEDIAN |
| SECONDARY | Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Adverse Events） | From the time a patient signed informed until 30 day safety follow-up visit or until initiation of new anticancer treatment, or assessed up to 30 months. | The as-treated (AT) population: the AT population contained all patients in the ITT population who received at least 1 dose of study medication and patients were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Laboratory Assessments） | From the time a patient signed informed until 30 day safety follow-up visit or until initiation of new anticancer treatment, or assessed up to 30 months. | The as-treated (AT) population: the AT population contained all patients in the ITT population who received at least 1 dose of study medication and patients were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival（OS）(Wild Type KRAS) | Every 8 weeks. Survival status should be collected for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met, whichever is later. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | months | MEDIAN |
| SECONDARY | Overall Survival（OS）(Mutant Type KRAS) | Every 8 weeks. Survival status should be collected for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met, whichever is later. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) (Wild Type KRAS) | Every 8 weeks. Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) (Mutant Type KRAS) | Every 8 weeks. Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met. | The intent-to-treat (ITT) population: the ITT population was comprised of all patients who were randomized to study medication. | Months | MEDIAN |
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/NCT01955837/outcomes