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Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02436668
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : November 16, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Adenocarcinoma
Interventions Drug: Ibrutinib
Drug: Gemcitabine
Drug: Nab-paclitaxel
Enrollment 430
Recruitment Details This study was conducted at 75 centers in the United States (US), European Union, and South Korea. The first subject enrolled 08 May 2015 and the last was enrolled on April 19, 2018.
Pre-assignment Details There was a safety run-in of 6 patients; subsequently, 430 total patients were enrolled. Eligible subjects were required to have a confirmed diagnosis of Stage IV pancreatic adenocarcinoma within 6 weeks of randomization evaluable per RECIST 1.1 criteria with at least 1 measurable metastatic lesion. Key exclusion criteria included any previous cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
Arm/Group Title Placebo+Gemcitabine+Nab-Paclitaxel Ibrutinib+Gemcitabine+Nab-paclitaxel
Hide Arm/Group Description

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine

Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine

Ibrutinib was administered orally once daily at a starting dose of 560 mg.

Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Period Title: Overall Study
Started 213 211
Completed 212 207
Not Completed 1 4
Arm/Group Title Pbo+n-P/G Ibr+n-P/G Total
Hide Arm/Group Description

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine

Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine

Ibrutinib- orally once daily at a starting dose of 560 mg.

Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Total of all reporting groups
Overall Number of Baseline Participants 213 211 424
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 211 participants 424 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
119
  55.9%
118
  55.9%
237
  55.9%
>=65 years
94
  44.1%
93
  44.1%
187
  44.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 213 participants 211 participants 424 participants
64.0
(32 to 85)
64.0
(32 to 82)
64.0
(32 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 211 participants 424 participants
Female
92
  43.2%
97
  46.0%
189
  44.6%
Male
121
  56.8%
114
  54.0%
235
  55.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 211 participants 424 participants
Hispanic or Latino
11
   5.2%
7
   3.3%
18
   4.2%
Not Hispanic or Latino
197
  92.5%
198
  93.8%
395
  93.2%
Unknown or Not Reported
5
   2.3%
6
   2.8%
11
   2.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 211 participants 424 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
59
  27.7%
53
  25.1%
112
  26.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   3.3%
5
   2.4%
12
   2.8%
White
142
  66.7%
146
  69.2%
288
  67.9%
More than one race
0
   0.0%
1
   0.5%
1
   0.2%
Unknown or Not Reported
5
   2.3%
6
   2.8%
11
   2.6%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first.
Time Frame Results at an overall median follow-up of 24.87 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibrutinib+Gemcitabine+Nab-paclitaxel Placebo+Gemcitabine+Nab-Paclitaxel
Hide Arm/Group Description:

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Overall Number of Participants Analyzed 211 213
Median (95% Confidence Interval)
Unit of Measure: Months
5.32
(3.75 to 5.49)
6.01
(5.45 to 7.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibrutinib+Gemcitabine+Nab-paclitaxel, Placebo+Gemcitabine+Nab-Paclitaxel
Comments The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors [KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. >65)] and with treatment as the only covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is from log-rank test stratified by the three randomization stratification factors [KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. >65)].
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.525
Confidence Interval (2-Sided) 95%
1.241 to 1.873
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival (OS)
Hide Description OS, is defined as the time from date of randomization until date of death from any cause.
Time Frame Results at an overall median follow-up of 24.87 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibrutinib+Gemcitabine+Nab-paclitaxel Placebo+Gemcitabine+Nab-Paclitaxel
Hide Arm/Group Description:

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Overall Number of Participants Analyzed 211 213
Median (95% Confidence Interval)
Unit of Measure: Months
9.69
(8.57 to 10.41)
10.78
(8.94 to 11.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibrutinib+Gemcitabine+Nab-paclitaxel, Placebo+Gemcitabine+Nab-Paclitaxel
Comments The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors [KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. >65)] and with treatment as the only covariate.
Type of Statistical Test Superiority
Comments P-value is based on log-rank test stratified by the three randomization stratification factors [KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. >65)].
Statistical Test of Hypothesis P-Value 0.3225
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.109
Confidence Interval (2-Sided) 95%
0.903 to 1.363
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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.
Hide Description This is a measure of percentage of subjects with Treatment Emergent Adverse Events Grade 3 or above collected Up to 30 days after the last participating subject discontinues study drug.
Time Frame Results at an overall median follow-up of 24.87 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included 420 subjects and was used for the analyses of all safety endpoints and included all subjects in the ITT population who received at least 1 dose of study drug (ibrutinib, placebo, nab-paclitaxel, or gemcitabine). The data sets analyzed are summarized in the following table.
Arm/Group Title Placebo+Gemcitabine+Nab-Paclitaxel Ibrutinib+Gemcitabine+Nab-paclitaxel
Hide Arm/Group Description:

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Overall Number of Participants Analyzed 212 208
Measure Type: Number
Unit of Measure: percentage of participants
Subjects with any TEAE >= Grade 3 86.8 85.6
Subjects with ibrutinib/pbo-related TEAE >=Grade 3 55.7 54.3
4.Secondary Outcome
Title Overall Response Rate
Hide Description ORR is defined as the percentage of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1.
Time Frame Results at an overall median follow-up of 24.87 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo+Gemcitabine+Nab-Paclitaxel Ibrutinib+Gemcitabine+Nab-paclitaxel
Hide Arm/Group Description:

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Overall Number of Participants Analyzed 213 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Patients
42.3
(35.5 to 49.2)
29.5
(23.3 to 36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Gemcitabine+Nab-Paclitaxel, Ibrutinib+Gemcitabine+Nab-paclitaxel
Comments For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo + Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.695
Confidence Interval (2-Sided) 95%
0.535 to 0.903
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Clinical Benefit Response
Hide Description

Subject achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card [MPAC]) or analgesic consumption, or a 20-point or greater improvement in KPS for a period of at least 4 consecutive weeks, without showing any sustained worsening in other parameters.

OR Subject was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation (Burris 1997).

Time Frame Results at an overall median follow-up of 24.87 months
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical benefit response rate was not analyzed due to incomplete data for the analgesic use. Data for subjects who "Achieved a >=50% reduction in pain intensity", "20-point or greater improvement in KPS (>=4 consecutive weeks)", "Sustained weight gain (>=7% increase maintained for >=4 weeks) not due to fluid accumulation"are reported.
Arm/Group Title Placebo+Gemcitabine+Nab-Paclitaxel Ibrutinib+Gemcitabine+Nab-paclitaxel
Hide Arm/Group Description:

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

I

Overall Number of Participants Analyzed 213 211
Measure Type: Number
Unit of Measure: percentage of patients
Achieved a >=50% reduction in pain intensity 25.8 27.5
>=20-pt improvement in KPS (>=4 consecutive weeks) 1.4 0
Sustained weight gain (>=7% maintained >4 weeks 11.7 5.7
6.Secondary Outcome
Title Carbohydrate Antigen 19-9 (CA19-9) Response
Hide Description The CA19-9 response rate is defined as the percentage of subjects with a decline of 20%, 90%, and other thresholds considered clinically meaningful, from baseline. This is a percentage of patients with > or = 60% reduction from baseline.
Time Frame Results at an overall median follow-up of 24.87 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo+Gemcitabine+Nab-Paclitaxel Ibrutinib+Gemcitabine+Nab-paclitaxel
Hide Arm/Group Description:

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Overall Number of Participants Analyzed 213 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
62.9
(56.0 to 69.4)
53.6
(46.6 to 60.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Gemcitabine+Nab-Paclitaxel, Ibrutinib+Gemcitabine+Nab-paclitaxel
Comments For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo+Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0488
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.850
Confidence Interval (2-Sided) 95%
0.722 to 1.0
Estimation Comments This 0.85 (0.722 to 1.0) with CI is referring to risk ratio not proportional/percentage of patients.
7.Secondary Outcome
Title Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
Hide Description Unit is the month: TUDD1 - the time between random & 1st occurrence of a decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further QoL data due to deterioration. The proportion of subjects who met the "responder" criteria prior to subsequent anticancer therapy initiation. Response defined as achievement of a ≥50% reduction in MPAC visual analog scale which measures pain intensity or analgesic consumption, or a ≥20-point improvement from baseline in KPS sustained for a period of ≥ 4 consecutive weeks without showing any sustained worsening from baseline in any of the other parameters OR Subject stable on all parameters (pain and KPS), & showed a marked, sustained weight gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation.
Time Frame Results at an overall median follow-up of 24.87 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo+Gemcitabine+Nab-Paclitaxel Ibrutinib+Gemcitabine+Nab-paclitaxel
Hide Arm/Group Description:

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Overall Number of Participants Analyzed 213 211
Median (95% Confidence Interval)
Unit of Measure: months
6.14
(4.86 to 8.21)
4.21
(2.86 to 5.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Gemcitabine+Nab-Paclitaxel, Ibrutinib+Gemcitabine+Nab-paclitaxel
Comments [1] Hazard ratio is based on a Cox proportional hazards model stratified by the three randomization stratification factors for time until definitive deterioration (TUDD1), a hazard ratio < 1 favors Ibr + Gem/Abr. TUDD1 is defined as the time interval between randomization and the first occurrence of a decrease in score by >= 10 points without any further improvement in score by >= 10 points or any further available QoL data due to dropout after deterioration.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0782
Comments P-value is from log-rank test stratified by the three randomization stratification factors.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.265
Confidence Interval (2-Sided) 95%
0.975 to 1.642
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Rate of Venous Thromboembolic Events (VTE)
Hide Description The VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment.
Time Frame Results at an overall median follow-up of 24.87 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo+Gemcitabine+Nab-Paclitaxel Ibrutinib+Gemcitabine+Nab-paclitaxel
Hide Arm/Group Description:

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.

Overall Number of Participants Analyzed 213 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
10.8
(7.0 to 15.8)
8.1
(4.8 to 12.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Gemcitabine+Nab-Paclitaxel, Ibrutinib+Gemcitabine+Nab-paclitaxel
Comments

For rate of VTEs, denominator is number of subjects in the Intent-to-Treat population and numerator is number of Intent-to-Treat subjects with at least one VTE observed any time on study. Confidence interval for rate of VTEs is based on Clopper-Pearson method.

[1] P value is based on Chi-square test.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3343
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame From first dose of study drug up to 30 days after the last dose of study drug
Adverse Event Reporting Description There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.
 
Arm/Group Title Placebo (Plus Nab-paclitaxel and Gemcitabine) Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)
Hide Arm/Group Description

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine

Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

Ibrutinib 560 mg (4 x 140 mg capsules) (or placebo) was administered orally once daily beginning on Day 1 of Cycle 1 of the treatment phase, with the first dose of ibrutinib given no more than 72 hours after randomization

Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion

All-Cause Mortality
Placebo (Plus Nab-paclitaxel and Gemcitabine) Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   188/212 (88.68%)      189/208 (90.87%)    
Hide Serious Adverse Events
Placebo (Plus Nab-paclitaxel and Gemcitabine) Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   127/212 (59.91%)      112/208 (53.85%)    
Blood and lymphatic system disorders     
Anaemia  1  9/212 (4.25%)  13 7/208 (3.37%)  7
Neutropenia  1  3/212 (1.42%)  3 6/208 (2.88%)  7
Thrombocytopenia  1  4/212 (1.89%)  6 4/208 (1.92%)  8
Febrile neutropenia  1  3/212 (1.42%)  3 1/208 (0.48%)  1
Disseminated intravascular coagulation  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Haemorrhagic diathesis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Pancytopenia  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  4/212 (1.89%)  4 3/208 (1.44%)  4
Left ventricular failure  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Supraventricular tachycardia  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Cardiac failure  1  3/212 (1.42%)  3 0/208 (0.00%)  0
Cardiac failure congestive  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Sinus tachycardia  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Eye disorders     
Cataract  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Gastrointestinal disorders     
Diarrhoea  1  9/212 (4.25%)  10 14/208 (6.73%)  17
Vomiting  1  6/212 (2.83%)  6 5/208 (2.40%)  9
Abdominal pain  1  11/212 (5.19%)  12 4/208 (1.92%)  7
Gastrointestinal haemorrhage  1  1/212 (0.47%)  2 4/208 (1.92%)  6
Duodenal obstruction  1  1/212 (0.47%)  1 3/208 (1.44%)  3
Intestinal obstruction  1  0/212 (0.00%)  0 3/208 (1.44%)  4
Nausea  1  7/212 (3.30%)  7 3/208 (1.44%)  6
Constipation  1  1/212 (0.47%)  1 2/208 (0.96%)  2
Duodenal ulcer haemorrhage  1  1/212 (0.47%)  1 2/208 (0.96%)  2
Gastric haemorrhage  1  0/212 (0.00%)  0 2/208 (0.96%)  2
Abdominal pain upper  1  2/212 (0.94%)  2 1/208 (0.48%)  1
Duodenal stenosis  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Enterocolitis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Flatulence  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Gastric ulcer  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Inguinal hernia strangulated  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Intussusception  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Large intestinal obstruction  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Melaena  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Neutropenic colitis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Pneumoperitoneum  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Rectal haemorrhage  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Small intestinal ulcer haemorrhage  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Stomatitis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Upper gastrointestinal haemorrhage  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Ascites  1  3/212 (1.42%)  3 0/208 (0.00%)  0
Dyspepsia  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Gastrointestinal obstruction  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Haematemesis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Irritable bowel syndrome  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Mesenteric vein thrombosis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Obstruction gastric  1  3/212 (1.42%)  3 0/208 (0.00%)  0
Pancreatitis  1  2/212 (0.94%)  2 0/208 (0.00%)  0
Peritoneal haemorrhage  1  1/212 (0.47%)  2 0/208 (0.00%)  0
Retching  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Small intestinal obstruction  1  1/212 (0.47%)  1 0/208 (0.00%)  0
General disorders     
Pyrexia  1  17/212 (8.02%)  20 13/208 (6.25%)  16
Asthenia  1  7/212 (3.30%)  7 6/208 (2.88%)  8
General physical health deterioration  1  5/212 (2.36%)  6 4/208 (1.92%)  5
Mucosal inflammation  1  0/212 (0.00%)  0 2/208 (0.96%)  2
Fatigue  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Systemic inflammatory response syndrome  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Chest pain  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Chills  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Gait disturbance  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Generalised oedema  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Hyperthermia  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Pain  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Hepatobiliary disorders     
Cholangitis  1  4/212 (1.89%)  6 9/208 (4.33%)  14
Hyperbilirubinaemia  1  0/212 (0.00%)  0 2/208 (0.96%)  2
Cholangitis acute  1  3/212 (1.42%)  3 1/208 (0.48%)  1
Cholecystitis  1  2/212 (0.94%)  2 1/208 (0.48%)  1
Cholecystitis acute  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Hepatic function abnormal  1  0/212 (0.00%)  0 1/208 (0.48%)  2
Hepatotoxicity  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Jaundice  1  2/212 (0.94%)  2 1/208 (0.48%)  1
Jaundice cholestatic  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Bile duct obstruction  1  4/212 (1.89%)  4 0/208 (0.00%)  0
Biliary dilatation  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Infections and infestations     
Pneumonia  1  8/212 (3.77%)  11 13/208 (6.25%)  14
Cellulitis  1  1/212 (0.47%)  1 4/208 (1.92%)  4
Infection  1  1/212 (0.47%)  1 4/208 (1.92%)  4
Liver abscess  1  0/212 (0.00%)  0 4/208 (1.92%)  4
Urinary tract infection  1  2/212 (0.94%)  2 4/208 (1.92%)  4
Bacteraemia  1  0/212 (0.00%)  0 3/208 (1.44%)  3
Escherichia sepsis  1  1/212 (0.47%)  2 3/208 (1.44%)  3
Biliary tract infection  1  1/212 (0.47%)  1 2/208 (0.96%)  2
Gastroenteritis  1  1/212 (0.47%)  1 2/208 (0.96%)  2
Neutropenic sepsis  1  2/212 (0.94%)  2 2/208 (0.96%)  2
Respiratory tract infection  1  0/212 (0.00%)  0 2/208 (0.96%)  2
Abdominal sepsis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Biliary sepsis  1  3/212 (1.42%)  3 1/208 (0.48%)  1
Candida sepsis  1  0/212 (0.00%)  0 1/208 (0.48%)  2
Clostridium difficile infection  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Cystitis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Empyema  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Enterobacter bacteraemia  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Gastrointestinal infection  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Infectious colitis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Lower respiratory tract infection  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Pharyngotonsillitis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Pneumocystis jirovecii pneumonia  1  4/212 (1.89%)  4 1/208 (0.48%)  1
Pneumonia bacterial  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Pseudomonal sepsis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Pulmonary sepsis  1  0/212 (0.00%)  0 1/208 (0.48%)  2
Pyelonephritis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Pyelonephritis acute  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Septic shock  1  3/212 (1.42%)  4 1/208 (0.48%)  2
Vascular device infection  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Anal abscess  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Bronchitis bacterial  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Device related infection  1  4/212 (1.89%)  5 0/208 (0.00%)  0
Diverticulitis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Erysipelas  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Escherichia bacteraemia  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Intervertebral discitis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Peritonitis bacterial  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Sepsis  1  4/212 (1.89%)  5 0/208 (0.00%)  0
Staphylococcal sepsis  1  1/212 (0.47%)  2 0/208 (0.00%)  0
Injury, poisoning and procedural complications     
Joint dislocation  1  0/212 (0.00%)  0 1/208 (0.48%)  2
Skin laceration  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Toxicity to various agents  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Bone contusion  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Patella fracture  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Blood bilirubin increased  1  2/212 (0.94%)  4 1/208 (0.48%)  2
Blood creatinine increased  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Aspartate aminotransferase increased  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Neutrophil count decreased  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Platelet count decreased  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Transaminases increased  1  2/212 (0.94%)  3 0/208 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Dehydration  1  5/212 (2.36%)  5 1/208 (0.48%)  1
Diabetes mellitus  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Hyponatraemia  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Metabolic acidosis  1  0/212 (0.00%)  0 1/208 (0.48%)  2
Diabetes mellitus inadequate control  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Enzyme abnormality  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Malnutrition  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  1/212 (0.47%)  1 4/208 (1.92%)  6
Myalgia  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Arthralgia  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Arthritis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Muscular weakness  1  2/212 (0.94%)  2 0/208 (0.00%)  0
Musculoskeletal pain  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic carcinoma  1  6/212 (2.83%)  8 6/208 (2.88%)  7
Pancreatic carcinoma metastatic  1  5/212 (2.36%)  8 5/208 (2.40%)  6
Adenocarcinoma pancreas  1  3/212 (1.42%)  4 2/208 (0.96%)  3
Cancer pain  1  4/212 (1.89%)  4 2/208 (0.96%)  2
Tumour pain  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Tumour haemorrhage  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Nervous system disorders     
Syncope  1  2/212 (0.94%)  2 3/208 (1.44%)  3
Cerebrovascular accident  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Guillain-Barre syndrome  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Haemorrhage intracranial  1  1/212 (0.47%)  1 1/208 (0.48%)  1
Hydrocephalus  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Ischaemic cerebral infarction  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Ischaemic stroke  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Peripheral sensorimotor neuropathy  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Seizure  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Wernicke's encephalopathy  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Cerebral infarction  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Epilepsy  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Metabolic encephalopathy  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Psychiatric disorders     
Depression  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Suicide attempt  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Confusional state  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  0/212 (0.00%)  0 3/208 (1.44%)  4
Urinary retention  1  2/212 (0.94%)  2 1/208 (0.48%)  1
Acute kidney injury  1  4/212 (1.89%)  5 0/208 (0.00%)  0
Azotaemia  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Haematuria  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Hydronephrosis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  3/212 (1.42%)  3 3/208 (1.44%)  4
Respiratory failure  1  1/212 (0.47%)  1 2/208 (0.96%)  2
Acute respiratory distress syndrome  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Dyspnoea  1  2/212 (0.94%)  2 1/208 (0.48%)  1
Interstitial lung disease  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Lung infiltration  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Pleural effusion  1  2/212 (0.94%)  2 1/208 (0.48%)  1
Pneumonitis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Pulmonary thrombosis  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Dyspnoea exertional  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Haemoptysis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Oropharyngeal pain  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Pulmonary oedema  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Tachypnoea  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  2/212 (0.94%)  3 0/208 (0.00%)  0
Vascular disorders     
Hypotension  1  0/212 (0.00%)  0 2/208 (0.96%)  2
Embolism  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Peripheral ischaemia  1  0/212 (0.00%)  0 1/208 (0.48%)  1
Arterial haemorrhage  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Deep vein thrombosis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Jugular vein thrombosis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Venous thrombosis  1  1/212 (0.47%)  1 0/208 (0.00%)  0
Venous thrombosis limb  1  1/212 (0.47%)  1 0/208 (0.00%)  0
1
Term from vocabulary, MedDRA Version 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Plus Nab-paclitaxel and Gemcitabine) Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   211/212 (99.53%)      208/208 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  95/212 (44.81%)  309 90/208 (43.27%)  289
Thrombocytopenia  1  55/212 (25.94%)  208 75/208 (36.06%)  221
Neutropenia  1  84/212 (39.62%)  328 68/208 (32.69%)  139
Leukopenia  1  18/212 (8.49%)  61 15/208 (7.21%)  19
Eye disorders     
Vision blurred  1  15/212 (7.08%)  18 17/208 (8.17%)  20
Gastrointestinal disorders     
Diarrhoea  1  109/212 (51.42%)  240 147/208 (70.67%)  357
Nausea  1  107/212 (50.47%)  242 116/208 (55.77%)  228
Vomiting  1  86/212 (40.57%)  184 85/208 (40.87%)  169
Constipation  1  78/212 (36.79%)  96 68/208 (32.69%)  91
Abdominal pain  1  67/212 (31.60%)  99 63/208 (30.29%)  94
Abdominal pain upper  1  27/212 (12.74%)  40 38/208 (18.27%)  64
Stomatitis  1  21/212 (9.91%)  28 36/208 (17.31%)  50
Dyspepsia  1  21/212 (9.91%)  26 34/208 (16.35%)  38
Ascites  1  25/212 (11.79%)  35 21/208 (10.10%)  30
Abdominal distension  1  13/212 (6.13%)  13 13/208 (6.25%)  15
General disorders     
Asthenia  1  93/212 (43.87%)  283 100/208 (48.08%)  311
Pyrexia  1  82/212 (38.68%)  181 85/208 (40.87%)  150
Fatigue  1  65/212 (30.66%)  170 78/208 (37.50%)  149
Oedema peripheral  1  77/212 (36.32%)  143 60/208 (28.85%)  97
Mucosal inflammation  1  19/212 (8.96%)  29 24/208 (11.54%)  36
Chills  1  15/212 (7.08%)  21 21/208 (10.10%)  24
Infections and infestations     
Urinary tract infection  1  16/212 (7.55%)  25 16/208 (7.69%)  23
Nasopharyngitis  1  15/212 (7.08%)  17 7/208 (3.37%)  10
Investigations     
Weight decreased  1  21/212 (9.91%)  33 14/208 (6.73%)  19
Platelet count decreased  1  17/212 (8.02%)  61 13/208 (6.25%)  26
Alanine aminotransferase increased  1  25/212 (11.79%)  42 12/208 (5.77%)  16
Neutrophil count decreased  1  19/212 (8.96%)  48 11/208 (5.29%)  19
Aspartate aminotransferase increased  1  18/212 (8.49%)  34 8/208 (3.85%)  12
Metabolism and nutrition disorders     
Decreased appetite  1  76/212 (35.85%)  129 85/208 (40.87%)  135
Hypokalaemia  1  20/212 (9.43%)  32 25/208 (12.02%)  37
Hypoalbuminaemia  1  16/212 (7.55%)  28 17/208 (8.17%)  24
Hypomagnesaemia  1  7/212 (3.30%)  16 11/208 (5.29%)  14
Dehydration  1  12/212 (5.66%)  14 5/208 (2.40%)  5
Musculoskeletal and connective tissue disorders     
Myalgia  1  35/212 (16.51%)  58 28/208 (13.46%)  36
Back pain  1  25/212 (11.79%)  38 25/208 (12.02%)  31
Arthralgia  1  26/212 (12.26%)  30 17/208 (8.17%)  20
Pain in extremity  1  24/212 (11.32%)  31 17/208 (8.17%)  24
Musculoskeletal pain  1  11/212 (5.19%)  13 11/208 (5.29%)  13
Musculoskeletal chest pain  1  11/212 (5.19%)  15 5/208 (2.40%)  5
Nervous system disorders     
Peripheral sensory neuropathy  1  63/212 (29.72%)  153 69/208 (33.17%)  171
Paraesthesia  1  20/212 (9.43%)  42 27/208 (12.98%)  79
Headache  1  20/212 (9.43%)  24 21/208 (10.10%)  25
Dizziness  1  20/212 (9.43%)  22 20/208 (9.62%)  22
Dysgeusia  1  26/212 (12.26%)  33 19/208 (9.13%)  24
Neuropathy peripheral  1  14/212 (6.60%)  28 15/208 (7.21%)  33
Neurotoxicity  1  18/212 (8.49%)  47 14/208 (6.73%)  40
Peripheral motor neuropathy  1  11/212 (5.19%)  23 13/208 (6.25%)  30
Psychiatric disorders     
Insomnia  1  34/212 (16.04%)  36 20/208 (9.62%)  23
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  21/212 (9.91%)  27 36/208 (17.31%)  41
Dyspnoea  1  43/212 (20.28%)  64 25/208 (12.02%)  34
Cough  1  42/212 (19.81%)  47 15/208 (7.21%)  19
Pleural effusion  1  16/212 (7.55%)  22 9/208 (4.33%)  14
Productive cough  1  12/212 (5.66%)  16 7/208 (3.37%)  7
Skin and subcutaneous tissue disorders     
Alopecia  1  87/212 (41.04%)  119 90/208 (43.27%)  130
Rash maculo-papular  1  28/212 (13.21%)  42 23/208 (11.06%)  28
Dry skin  1  6/212 (2.83%)  7 14/208 (6.73%)  16
Rash erythematous  1  15/212 (7.08%)  21 12/208 (5.77%)  16
Pruritus  1  25/212 (11.79%)  36 8/208 (3.85%)  8
Vascular disorders     
Hypotension  1  13/212 (6.13%)  15 12/208 (5.77%)  15
Hypertension  1  13/212 (6.13%)  34 11/208 (5.29%)  33
1
Term from vocabulary, MedDRA Version 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
  1. Institution/Investigator will not publish without Sponsor prior review and approval
  2. Institution/Investigator will not publish until the earlier of (i) results of study are submitted for publication (ii) notification that submission of the multicenter results are no longer planned (iii) 18 months after study termination.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: George Cole
Organization: Pharmacyclics, An AbbVie Company
Phone: (408) 990-7340
EMail: gcole@pcyc.com
Layout table for additonal information
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02436668    
Other Study ID Numbers: PCYC-1137-CA
First Submitted: May 4, 2015
First Posted: May 7, 2015
Results First Submitted: October 31, 2019
Results First Posted: November 16, 2020
Last Update Posted: December 30, 2020