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Trial · NCT02436668

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Progression Free Survival (PFS)Ibrutinib+Gemcitabine+Nab-paclitaxel5.3295% Confidence Interval 3.75 to 5.49Months
Progression Free Survival (PFS)Placebo+Gemcitabine+Nab-Paclitaxel6.0195% Confidence Interval 5.45 to 7.16Months
Overall Survival (OS)Ibrutinib+Gemcitabine+Nab-paclitaxel9.6995% Confidence Interval 8.57 to 10.41Months
Overall Survival (OS)Placebo+Gemcitabine+Nab-Paclitaxel10.7895% Confidence Interval 8.94 to 11.66Months
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.Placebo+Gemcitabine+Nab-PaclitaxelSubjects with any TEAE >= Grade 386.8percentage of participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.Ibrutinib+Gemcitabine+Nab-paclitaxelSubjects with any TEAE >= Grade 385.6percentage of participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.Placebo+Gemcitabine+Nab-PaclitaxelSubjects with ibrutinib/pbo-related TEAE >=Grade 355.7percentage of participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.Ibrutinib+Gemcitabine+Nab-paclitaxelSubjects with ibrutinib/pbo-related TEAE >=Grade 354.3percentage of participants
Overall Response RatePlacebo+Gemcitabine+Nab-Paclitaxel42.395% Confidence Interval 35.5 to 49.2percentage of Patients
Overall Response RateIbrutinib+Gemcitabine+Nab-paclitaxel29.595% Confidence Interval 23.3 to 36percentage of Patients
Clinical Benefit ResponsePlacebo+Gemcitabine+Nab-PaclitaxelAchieved a >=50% reduction in pain intensity25.8percentage of patients
Clinical Benefit ResponseIbrutinib+Gemcitabine+Nab-paclitaxelAchieved a >=50% reduction in pain intensity27.5percentage of patients
Clinical Benefit ResponsePlacebo+Gemcitabine+Nab-Paclitaxel>=20-pt improvement in KPS (>=4 consecutive weeks)1.4percentage of patients
Clinical Benefit ResponseIbrutinib+Gemcitabine+Nab-paclitaxel>=20-pt improvement in KPS (>=4 consecutive weeks)0percentage of patients
Clinical Benefit ResponsePlacebo+Gemcitabine+Nab-PaclitaxelSustained weight gain (>=7% maintained >4 weeks11.7percentage of patients
Clinical Benefit ResponseIbrutinib+Gemcitabine+Nab-paclitaxelSustained weight gain (>=7% maintained >4 weeks5.7percentage of patients
Carbohydrate Antigen 19-9 (CA19-9) ResponsePlacebo+Gemcitabine+Nab-Paclitaxel62.995% Confidence Interval 56.0 to 69.4percentage of patients
Carbohydrate Antigen 19-9 (CA19-9) ResponseIbrutinib+Gemcitabine+Nab-paclitaxel53.695% Confidence Interval 46.6 to 60.4percentage of patients
Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).Placebo+Gemcitabine+Nab-Paclitaxel6.1495% Confidence Interval 4.86 to 8.21months
Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).Ibrutinib+Gemcitabine+Nab-paclitaxel4.2195% Confidence Interval 2.86 to 5.82months

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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