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Trial · NCT02426125

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProgression Free Survival (PFS)Randomization to Radiological Disease Progression or Death from Any Cause (Up to 18 Months)The first randomized participants. Censored participants: Ramucirumab + Docetaxel = 58, Placebo + Docetaxel =38.MonthsMEDIAN
SECONDARYOverall Survival (OS)Randomization to Date of Death from Any Cause (Up to 31.1 Months)All randomized participants. Censored participants: Ramucirumab + Docetaxel = 78, Placebo + Docetaxel = 67.MonthsMEDIAN
SECONDARYPercentage of Participants With an Objective Response Rate (ORR)Randomization to Disease Progression (Up to 29.7 Months)All randomized participants.percentage of participantsNUMBER
SECONDARYPercentage of Participants With Disease Control Rate (DCR)Randomization to Disease Progression (Up to 29.7 Months)All randomized participants.percentage of participantsNUMBER
SECONDARYDuration of Response (DoR)Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 28.4 Months)All randomized participants with CR or PR. Participants censored in Ramucirumab + Docetaxel = 12 and in Placebo + Docetaxel = 5.MonthsMEDIAN
SECONDARYTime to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL ScaleRandomization, 30 Days After Treatment Discontinuation (Up to 18 Months)All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173.MonthsMEDIAN
SECONDARYChange From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index ScoreRandomization, 30 Days After Treatment Discontinuation (Up to 18 Months)All randomized participants with baseline and 30-day follow-up data.units on a scaleMEAN
SECONDARYChange From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)All randomized participants with baseline and 30-day follow-up data.millimeter (mm)MEAN
SECONDARYPharmacokinetics (PK): Maximum Concentration (Cmax) of RamucirumabCycle 1 and Cycle 9, Day 1: Predose, PostdoseAll randomized participants who had evaluable PK data.microgram/milliliter (μg/mL)GEOMETRIC_MEAN
SECONDARYPK: Minimum Concentration (Cmin) of RamucirumabDay 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose)All randomized participants who had evaluable PK data.μg/mLGEOMETRIC_MEAN
SECONDARYNumber of Participants With Anti-Ramucirumab Antibodies29.7 MonthsAll randomized participants who received at least one dose of study drug at baseline and post-baseline.ParticipantsCOUNT_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.

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