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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Janssen Research & Development, LLC | INDUSTRY |
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The purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and MEDI4736 in subjects with relapsed or refractory lymphomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b/ 2: Follicular lymphoma expansion cohort | Experimental | In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 explored in cohort 1 and followed a 6+3 dose de-escalation design. Phase 2 used the phase 1b starting dose. |
|
| Phase 1b/ 2: Diffuse large B-cell lymphoma expansion cohort | Experimental | In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 explored in cohort 1 and followed a 6+3 dose de-escalation design. Phase 2 used the phase 1b starting dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b/2 : Overall Response Rate of Number of Participants | The response criteria is measured based on the revised criteria for malignant lymphoma described by the International Working Group for NHL (Cheson 2014). | From the date of first study treatment until progressive disease |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b/ 2: Duration of Response | Time from the date of initial response to the date of disease progression or the date of death due to any cause, whichever occurs first. | |
| Phase 1b/ 2: Progression-free Survival (PFS) | first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression |
Not provided
Inclusion Criteria:
Pathologically documented relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL)
Measurable disease sites on CT scan (>1.5 cm in longest dimension)
Adequate hematologic function:
Adequate hepatic and renal function:
ECOG 0 or 1
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Liu | Pharmacyclics LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site-0397 | Birmingham | Alabama | 35294 | United States | ||
| Site-0047 |
While the study include Phase 1b and 2, the dosing was not changed between phases (following the study design because there were no DLTs and thus no dose adjustments in from Phase 1b to Phase 2). Thus the study data were reported with Phases 1b and 2 combined.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 explored in cohort 1 and followed a 6+3 dose de-escalation design. Phase 2 used the phase 1b starting dose. |
| FG001 | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2015 | Oct 25, 2018 |
Not provided
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| MEDI4736 |
| Drug |
|
| Phase 1b/2: Overall Survival | First dose date of study drug (ibrutinib or MEDI4736) to the date of death due to any cause |
| Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib | Maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) |
| Pharmacokinetics: Mean Time to Maximum Observed Plasma Concentration (Tmax) for Ibrutinib | Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) |
| Pharmacokinetics: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC0-24h) for Ibrutinib | Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) |
| Pharmacokinetics: Mean Terminal Elimination Half-Life (t1/2,Term) for Ibrutinib | Ibrutinib terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic plasma concentration-time curve, calculated as 0.693/λz on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) |
| Pharmacokinetics: Mean Peak Plasma Concentration (Cmax) for MEDI4736 | Peak plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI) | Cycle 6 Day 1 (collected 10 minutes after end of infusion) |
| Pharmacokinetics: Mean Trough Plasma Concentration (Ctrough) for MEDI4736 | Trough plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI) | Cycle 6 Day 1 (predose) |
| Pharmacokinetics: MEDI4736 Accumulation Ratio for Cmax | Accumulation ratio from Cycle 6 Day 1 to Cycle 1 Day 1 for Cmax for MEDI4736 | Cycle 6 Day 1 (collected 10 minutes after end of infusion) |
| Pharmacokinetics: MEDI4736 Accumulation Ratio for Ctrough | Accumulation ratio from Cycle 6 Day 1 to Cycle 1 Day 1 for Ctrough for MEDI4736 | Cycle 6 Day 1 (predose) |
| Bruton Tyrosine Kinase (BTK) Occupancy | BTK occupancy | ibrutinib Lead-in Day 6 or 7 pre-dose |
| Pharmacodynamics of Ibrutinib in Subjects With Relapsed or Refractory Lymphomas | BTK occupancy | Cycle 3 Day 1 Pre-dose |
| Pharmacodynamics of MEDI4736 in Subjects With Relapsed or Refractory Lymphomas | Detectable Free Serum PD-L1 level | Cycle 3 Day1 Pre-dose |
| Duarte |
| California |
| 91010 |
| United States |
| Site-0038 | Stanford | California | 94305 | United States |
| Site-0388 | Miami | Florida | 33136 | United States |
| Site-0126 | Chicago | Illinois | 60637 | United States |
| Site-0020/0173 | Boston | Massachusetts | 02114 | United States |
| Site-0729 | Ann Arbor | Michigan | 48109 | United States |
| Site-0130 | Detroit | Michigan | 48201 | United States |
| Site-0343 | Hackensack | New Jersey | 07601 | United States |
| Site-0402 | Philadelphia | Pennsylvania | 19104 | United States |
| Site-0114 | Seattle | Washington | 98104 | United States |
In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 explored in cohort 1 and followed a 6+3 dose de-escalation design. Phase 2 used the phase 1b starting dose. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | All participants who received at least one dose of study treatment. |
| BG001 | Phase 1b/2: Diffuse Large B-cell Lymphoma Expansion Cohort: | All participants who received at least one dose of study treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1b/2 : Overall Response Rate of Number of Participants | The response criteria is measured based on the revised criteria for malignant lymphoma described by the International Working Group for NHL (Cheson 2014). | While the study include Phase 1b and 2, the dosing was not changed between phases (following the study design because there were no DLTs and thus no dose adjustments in from Phase 1b to Phase 2). Thus the study data were reported with Phases 1b and 2 combined. | Posted | Count of Participants | Participants | From the date of first study treatment until progressive disease |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Phase 1b/ 2: Duration of Response | Posted | Median | 95% Confidence Interval | Months | Time from the date of initial response to the date of disease progression or the date of death due to any cause, whichever occurs first. |
|
| |||||||||||||||||||||||||||||||
| Secondary | Phase 1b/ 2: Progression-free Survival (PFS) | Posted | Median | 95% Confidence Interval | Months | first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression |
|
| |||||||||||||||||||||||||||||||
| Secondary | Phase 1b/2: Overall Survival | Posted | Median | 95% Confidence Interval | Months | First dose date of study drug (ibrutinib or MEDI4736) to the date of death due to any cause |
|
| |||||||||||||||||||||||||||||||
| Secondary | Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib | Maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | ng/mL | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Mean Time to Maximum Observed Plasma Concentration (Tmax) for Ibrutinib | Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Median | Full Range | hour | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC0-24h) for Ibrutinib | Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | ng*h/mL | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Mean Terminal Elimination Half-Life (t1/2,Term) for Ibrutinib | Ibrutinib terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic plasma concentration-time curve, calculated as 0.693/λz on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | hour | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Mean Peak Plasma Concentration (Cmax) for MEDI4736 | Peak plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Cycle 6 Day 1 (collected 10 minutes after end of infusion) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Mean Trough Plasma Concentration (Ctrough) for MEDI4736 | Trough plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Cycle 6 Day 1 (predose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: MEDI4736 Accumulation Ratio for Cmax | Accumulation ratio from Cycle 6 Day 1 to Cycle 1 Day 1 for Cmax for MEDI4736 | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | Posted | Mean | Standard Deviation | ratio | Cycle 6 Day 1 (collected 10 minutes after end of infusion) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: MEDI4736 Accumulation Ratio for Ctrough | Accumulation ratio from Cycle 6 Day 1 to Cycle 1 Day 1 for Ctrough for MEDI4736 | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | Posted | Mean | Standard Deviation | ratio | Cycle 6 Day 1 (predose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Bruton Tyrosine Kinase (BTK) Occupancy | BTK occupancy | All participants who received at least one dose of study treatment and had evaluable pharmacodynamics data. | Posted | Mean | Standard Error | BTK % occupancy | ibrutinib Lead-in Day 6 or 7 pre-dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacodynamics of Ibrutinib in Subjects With Relapsed or Refractory Lymphomas | BTK occupancy | All participants who received at least one dose of study treatment and had evaluable pharmacodynamics data. | Posted | Mean | Standard Error | BTK % occupancy | Cycle 3 Day 1 Pre-dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacodynamics of MEDI4736 in Subjects With Relapsed or Refractory Lymphomas | Detectable Free Serum PD-L1 level | In Follicular lymphoma expansion cohort, 7 subjects are below limit of quantitation. In Diffuse large B-cell lymphoma expansion cohort, all subjects below limit of quantitation. | Posted | Number | pg/mL | Cycle 3 Day1 Pre-dose |
|
|
All AEs, whether serious or non-serious, are documented in the source documents from the time the signed and dated ICF is obtained until 30 days following the last dose of ibrutinib and 90 days following the last dose of MEDI4736.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | All subjects who received at least one dose of study treatment. | 6 | 27 | 10 | 27 | 27 | 27 |
| EG001 | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | All subjects who received at least one dose of study treatment. | 24 | 34 | 23 | 34 | 33 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Febrile Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Left Ventricular Failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypercalcaemia of malignancy | Endocrine disorders | Non-systematic Assessment |
| ||
| Oesophagitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Oedema peripheral | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Autoimmune hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchopulmonary aspergillosis | Infections and infestations | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Electrocardiogram QT prolonged | Investigations | Non-systematic Assessment |
| ||
| Hypercalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Electrolyte imbalance | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Tumour rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Tremor | Nervous system disorders | Non-systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Ureteric obstruction | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash generalised | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Increased tendancy to bruise | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Cataract | Eye disorders | Non-systematic Assessment |
| ||
| Dry eye | Eye disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Oedema peripheral | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Peripheral swelling | General disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Weight decreased | Investigations | Non-systematic Assessment |
| ||
| Weight increased | Investigations | Non-systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypercalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysguesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Memory impairment | Nervous system disorders | Non-systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Oropharyngeal | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Liu | Pharmacyclics | (669) 224-1899 | aliu@pcyc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2018 | Oct 25, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
| C000613593 | durvalumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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