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| ID | Type | Description | Link |
|---|---|---|---|
| PCI-32765 | Other Identifier | Sponsor |
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The primary objective of this study is to determine the efficacy of PCI-32765, both as a single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and refractory Multiple Myeloma (MM)
Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. PCI 32765 is a potent and specific inhibitor of Btk currently in Phase 2 clinical trials. The current study is designed and intended to determine the effects of PCI-32765 in subjects with MM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | PCI-32765 420 mg per day |
|
| Cohort 2 | Experimental | PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week |
|
| Cohort 3 | Experimental | PCI-32765 840 mg per day |
|
| Cohort 4 | Experimental | PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI-32765 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Clinical Benefit Response (CBR) | The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria | From the date of first study treatment until disease progression per IMWG, up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Efficacy of PCI-32765 by Assessing ORR | The objective response rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the modified International Myeloma Working Group (IMWG) response criteria. | From the date of first study treatment until disease progression per IMWG, up to 60 months |
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Inclusion Criteria:
Diagnosis of symptomatic MM with measurable disease, defined here as having at least one of the following:
Relapsed or relapsed and refractory MM after receiving at least 2 but no more than 5 previous lines of therapy, 1 of which must be an immunomodulator.
Refractory myeloma (to most recent treatment) is defined as disease that is nonresponsive while on treatment or progressive disease within 60 days after the completion of preceding treatment. Nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy.
Men and women ≥18 years of age.
ECOG performance status of ≤ 1.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SITE-13 | La Jolla | California | 92093 | United States | ||
| SITE-5 |
Simon 2-stage design . Stage 1 -13 subjects enrolled in cohort 1. For cohort 2,3, and 4, up to 18 subjects were enrolled in Stage 1. Cohort 4 was selected for expansion for enrollment of 43 subjects in Stage 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | PCI-32765 420 mg Per Day | PCI-32765 420 mg per day PCI-32765 |
| FG001 | PCI-32765 560 mg Per Day, 40 mg Dexamethasone | PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 18, 2016 | Mar 19, 2019 |
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| Dexamethasone |
| Drug |
|
| Pharmacokinetics (PK). (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Maximum Observed Plasma Concentration (Cmax) | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8. | Procedure was performed up to 60 weeks. |
| Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Time to Maximum Observed Plasma Concentration (Tmax). | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8. | Procedure was performed up to 60 weeks. |
| Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h). | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Day 8. | Procedure was performed up to 60 weeks. |
| Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Terminal Elimination Half-life (t1/2,Term). | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. 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 Day 8. | Procedure was performed up to 60 weeks. |
| Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Accumulation Ratio for AUC0-24h (Acc. Ratio AUC0-24h) | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Acc. Ratio calculated as Day 8 ibrutinib AUC0-24h/ Day 1 ibrutinib AUC0-24h. | Procedure was performed up to 60 weeks. |
| Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for Cmax (M/P Cmax) | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 Cmax/PCI-45227 molecular weight)/(ibrutinib Cmax/ibrutinib molecular weight) on Day 8. | Procedure was performed up to 60 weeks. |
| Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for AUC0-24h (M/P AUC0-24h) | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 AUC0-24h/PCI-45227 molecular weight)/(ibrutinib AUC0-24h/ibrutinib molecular weight) on Day 8. | Procedure was performed up to 60 weeks. |
| Duration of Clinical Benefit Response (DCB) | DCB is defined as the time from first observation of response to the time of disease progression. | From the date of first study treatment until disease progression per IMWG, up to 60 months |
| Duration of Response (DOR) | The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date. | up to 3 Years |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| SITE-4 | Boston | Massachusetts | 02215 | United States |
| SITE-8 | Ann Arbor | Michigan | 48109 | United States |
| SITE-2 | St Louis | Missouri | 63110 | United States |
| SITE-6 | Hackensack | New Jersey | 07601 | United States |
| SITE-10 | New York | New York | 10029 | United States |
| SITE-3 | New York | New York | 10065 | United States |
| SITE-1 | Nashville | Tennessee | 37203 | United States |
| SITE-11 | Dallas | Texas | 75390 | United States |
| SITE-9 | Seattle | Washington | 98109 | United States |
| FG002 | PCI-32765 840 mg Per Day | PCI-32765 840 mg per day PCI-32765 |
| FG003 | PCI-32765 840 mg Per Day, 40 mg Dexamethasone | PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | PCI-32765 420 mg per day PCI-32765 |
| BG001 | Cohort 2 | PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone |
| BG002 | Cohort 3 | PCI-32765 840 mg per day PCI-32765 |
| BG003 | Cohort 4 | PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone |
| BG004 | 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, Continuous | Median | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | We have 5 patients with Race reported as "Other". For these 5 patients we reported the race data under "Unknown or Not Reported" as no "Other" category available in this database. | 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 | The Clinical Benefit Response (CBR) | The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria | All treated population | Posted | Count of Participants | Participants | From the date of first study treatment until disease progression per IMWG, up to 60 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Efficacy of PCI-32765 by Assessing ORR | The objective response rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the modified International Myeloma Working Group (IMWG) response criteria. | All treated population | Posted | Count of Participants | Participants | From the date of first study treatment until disease progression per IMWG, up to 60 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK). (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Maximum Observed Plasma Concentration (Cmax) | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8. | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | ng/mL | Procedure was performed up to 60 weeks. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Time to Maximum Observed Plasma Concentration (Tmax). | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8. | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | hours | Procedure was performed up to 60 weeks. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h). | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Day 8. | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | h∙ng/mL | Procedure was performed up to 60 weeks. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Terminal Elimination Half-life (t1/2,Term). | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. 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 Day 8. | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | hours | Procedure was performed up to 60 weeks. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Accumulation Ratio for AUC0-24h (Acc. Ratio AUC0-24h) | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Acc. Ratio calculated as Day 8 ibrutinib AUC0-24h/ Day 1 ibrutinib AUC0-24h. | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | Ratio | Procedure was performed up to 60 weeks. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for Cmax (M/P Cmax) | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 Cmax/PCI-45227 molecular weight)/(ibrutinib Cmax/ibrutinib molecular weight) on Day 8. | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | Ratio | Procedure was performed up to 60 weeks. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for AUC0-24h (M/P AUC0-24h) | Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 AUC0-24h/PCI-45227 molecular weight)/(ibrutinib AUC0-24h/ibrutinib molecular weight) on Day 8. | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Mean | Standard Deviation | Ratio | Procedure was performed up to 60 weeks. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Clinical Benefit Response (DCB) | DCB is defined as the time from first observation of response to the time of disease progression. | Clinical benefit responders. | Posted | Median | Full Range | Months | From the date of first study treatment until disease progression per IMWG, up to 60 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date. | Responders | Posted | Median | 95% Confidence Interval | Month | up to 3 Years |
|
Five Years
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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 | Cohort 1 | PCI-32765 420 mg per day PCI-32765 | 2 | 13 | 6 | 13 | 12 | 13 |
| EG001 | Cohort 2 | PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone | 1 | 18 | 6 | 18 | 18 | 18 |
| EG002 | Cohort 3 | PCI-32765 840 mg per day PCI-32765 | 1 | 18 | 7 | 18 | 17 | 18 |
| EG003 | Cohort 4 | PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone | 1 | 43 | 12 | 43 | 43 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
| ||
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Aspergillus Infection | Infections and infestations | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bacterial Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Bone Lesion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bronchopulmonary Aspergillosis | Infections and infestations | Systematic Assessment |
| ||
| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Clostridium Difficile Colitis | Infections and infestations | Systematic Assessment |
| ||
| Device Related Infection | Infections and infestations | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epiglottitis | Infections and infestations | Systematic Assessment |
| ||
| Escherichia Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis Viral | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Groin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hernia Pain | General disorders | Systematic Assessment |
| ||
| Herpes Zoster Disseminated | Infections and infestations | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Ischaemic Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Lipase Increased | Investigations | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Pathological Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small Intestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Streptococcal Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Urinary tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Wound Secretion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Pain In Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Oedema Peripheral | General disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Vision Blurred | Eye disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Localised Infection | Infections and infestations | Systematic Assessment |
| ||
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Peripheral Sensory Neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Weight Decreased | Investigations | Systematic Assessment |
| ||
| Increased tendency to bruise | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bandaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial ischaemia | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hypoacusis | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear Discomfort | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Deafness unilateral | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear Congestion | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Otorrhoea | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Tympanic membrane disorder | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Tympanic membrane perforation | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Cushingoid | Endocrine disorders | Systematic Assessment |
| ||
| Goitre | Endocrine disorders | Systematic Assessment |
| ||
| Eye haemorrhage | Eye disorders | Systematic Assessment |
| ||
| Eye irritation | Eye disorders | Systematic Assessment |
| ||
| Abnormal sensation in eye | Eye disorders | Systematic Assessment |
| ||
| Asthenopia | Eye disorders | Systematic Assessment |
| ||
| Cataract | Eye disorders | Systematic Assessment |
| ||
| Choroidal infarction | Eye disorders | Systematic Assessment |
| ||
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Dry eye | Eye disorders | Systematic Assessment |
| ||
| Eye discharge | Eye disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Eye Pruritus | Eye disorders | Systematic Assessment |
| ||
| Eyelid disorder | Eye disorders | Systematic Assessment |
| ||
| Eyelid oedema | Eye disorders | Systematic Assessment |
| ||
| Glaucoma | Eye disorders | Systematic Assessment |
| ||
| Iritis | Eye disorders | Systematic Assessment |
| ||
| Lacrimation increased | Eye disorders | Systematic Assessment |
| ||
| Ophthalmoplegia | Eye disorders | Systematic Assessment |
| ||
| Retinal haemorrhage | Eye disorders | Systematic Assessment |
| ||
| Uveitis | Eye disorders | Systematic Assessment |
| ||
| Vitreous floaters | Eye disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aphthous ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal tenderness | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anal incontinence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Angina bullosa haemorrhagica | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dental caries | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faeces soft | Gastrointestinal disorders | Systematic Assessment |
| ||
| Frequent bowel movements | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hiatus hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypoaesthesia oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Irritable bowel syndrome | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lip blister | Gastrointestinal disorders | Systematic Assessment |
| ||
| Melaena | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mouth haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Odynophagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral Discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral mucosa erosion | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Parotid gland enlargement | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tongue eruption | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tooth disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tooth loss | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Peripheral swelling | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Feeling jittery | General disorders | Systematic Assessment |
| ||
| Chest discomfort | General disorders | Systematic Assessment |
| ||
| Feeling abnormal | General disorders | Systematic Assessment |
| ||
| Injection site bruising | General disorders | Systematic Assessment |
| ||
| Crepitations | General disorders | Systematic Assessment |
| ||
| Facial pain | General disorders | Systematic Assessment |
| ||
| Hernia pain | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Systemic inflammatory response syndrome | General disorders | Systematic Assessment |
| ||
| Unevaluable event | General disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic steatosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Food allergy | Immune system disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Paronychia | Infections and infestations | Systematic Assessment |
| ||
| Ear Infection | Infections and infestations | Systematic Assessment |
| ||
| Herpes Zoster | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Candida infection | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Parainfluenzae virus infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchopulmonary aspergillosis | Infections and infestations | Systematic Assessment |
| ||
| Chronic sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Corona virus infection | Infections and infestations | Systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Ear infection staphylococcal | Infections and infestations | Systematic Assessment |
| ||
| Epididymitis | Infections and infestations | Systematic Assessment |
| ||
| Epiglottitis | Infections and infestations | Systematic Assessment |
| ||
| Eye infection | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
| ||
| Helicobacter infection | Infections and infestations | Systematic Assessment |
| ||
| Herpes simplex | Infections and infestations | Systematic Assessment |
| ||
| Measles | Infections and infestations | Systematic Assessment |
| ||
| Oral herpes | Infections and infestations | Systematic Assessment |
| ||
| Otitis externa | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Rash pustular | Infections and infestations | Systematic Assessment |
| ||
| Rhinovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Systemic candida | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Accidental overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dental restoration failure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Eye contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Joint injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Muscle rupture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pubis fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Spinal compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Testicular injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Breath sounds abnormal | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase decreased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Blood chloride increased | Investigations | Systematic Assessment |
| ||
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
| ||
| Body temperature increased | Investigations | Systematic Assessment |
| ||
| Cardiac murmur | Investigations | Systematic Assessment |
| ||
| Heart rate irregular | Investigations | Systematic Assessment |
| ||
| Lymphocyte count increased | Investigations | Systematic Assessment |
| ||
| Medical observation abnormal | Investigations | Systematic Assessment |
| ||
| Neutrophil count increased | Investigations | Systematic Assessment |
| ||
| Red blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Weight increased | Investigations | Systematic Assessment |
| ||
| White blood cell count increased | Investigations | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperphosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Iron deficiency | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Chondropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Coccydynia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Limb mass | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle oedema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Soft tissue mass | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Spinal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Synovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Disturbance in attention | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Psychomotor hyperactivity | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Aphasia | Nervous system disorders | Systematic Assessment |
| ||
| Ataxia | Nervous system disorders | Systematic Assessment |
| ||
| Balance disorder | Nervous system disorders | Systematic Assessment |
| ||
| Burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| Drooling | Nervous system disorders | Systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Systematic Assessment |
| ||
| Migraine with aura | Nervous system disorders | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Systematic Assessment |
| ||
| Sinus headache | Nervous system disorders | Systematic Assessment |
| ||
| Mood swings | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Adjustment disorder with depressed mood | Psychiatric disorders | Systematic Assessment |
| ||
| Affect lability | Psychiatric disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Claustrophobia | Psychiatric disorders | Systematic Assessment |
| ||
| Depressed mood | Psychiatric disorders | Systematic Assessment |
| ||
| Hallucination | Psychiatric disorders | Systematic Assessment |
| ||
| Restlessness | Psychiatric disorders | Systematic Assessment |
| ||
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal impairment | Renal and urinary disorders | Systematic Assessment |
| ||
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Nocturia | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Breast ulceration | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Scrotal pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Uterine cyst | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulvovaginal pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal cyst | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rales | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin fissures | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin mass | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Actinic keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Blood blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Cold sweat | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hirsutism | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail bed inflammation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail growth abnormal | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Onychoclasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Papule | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Precancerous skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus generalised | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash erythematous | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin warm | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Telangiectasia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Vitiligo | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hot flush | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
| ||
| Pallor | Vascular disorders | Systematic Assessment |
| ||
| Small intestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bernhard Hauns, Medical Monitor | Pharmacyclics Switzerland GmbH | +41 52 556 0800 | bhauns@pcyc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2016 | Mar 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|
|
|
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|