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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.
This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revlimid, Cyclophosphamide, Prednisone | Experimental | Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days. Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days. Prednisone every other day orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide (Revlimid®) | Drug | 25 mg p.o. daily on days 1-21 of each 28 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria | Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. | After 6 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Adverse Events Grade 3 or Higher | Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater. | Beginning of treatment up to 5 years |
| Quality of Life Using the FACT-G Data |
Not provided
Inclusion Criteria:
Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria:
PLUS one or more of the following:
Measurable disease is defined at least one of the following three measurements:
Laboratory test results within these ranges:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Attaya Suvannasankha, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Original Study - Revlimid, Cyclophosphamide, Prednisone | Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. |
| FG001 | Extension - Revlimid, Cyclophosphamide, Prednisone | Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Original Study - Revlimid, Cyclophosphamide, Prednisone | Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. |
| BG001 | Extension - Revlimid, Cyclophosphamide, Prednisone |
| 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 |
| 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 | Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria | Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. | All patients receiving at least one dose of study drug and having at least one post-baseline visit | Posted | Number | 95% Confidence Interval | percentage of participants | After 6 cycles |
|
up to 5 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 | Original Study - Revlimid, Cyclophosphamide, Prednisone | Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PALPITATIONS | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Attaya Suvannasankha | IndianaU | 317-944-0920 | asuvanna@iu.edu |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003520 | Cyclophosphamide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Cyclophosphamide | Drug | 50 mg p.o. BID daily on days 1-21 of each 28 day cycle |
|
| Prednisone | Drug | 50 mg p.o. Q.O.D. |
|
Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome |
| baseline and after last cycle (up to 6 cycles) |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Noncomplilance |
|
Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Extension - Revlimid, Cyclophosphamide, Prednisone | Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. |
|
|
| Secondary | Treatment Related Adverse Events Grade 3 or Higher | Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater. | All patients enrolled and received treatment. | Posted | Number | participants | Beginning of treatment up to 5 years |
|
|
|
| Secondary | Quality of Life Using the FACT-G Data | Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome | All patients enrolled and received treatment with a baseline and post-baseline measurement. | Posted | Mean | Standard Deviation | scores on a scale | baseline and after last cycle (up to 6 cycles) |
|
|
|
| 12 |
| 48 |
| 48 |
| 48 |
| EG001 | Extension - Revlimid, Cyclophosphamide, Prednisone | Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. | 5 | 22 | 22 | 22 |
|
| CARDIAC GENERAL - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMOGLOBIN | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUTROPHILS/GRANULOCYTES (ANC/AGC) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - BACK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - EXTREMITY-LIMB | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CONFUSION | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY - OTHER | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FLU-LIKE SYNDROME | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| AUDITORY/EAR - OTHER | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| OTITIS, MIDDLE EAR (NON-INFECTIOUS) | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| OCULAR/VISUAL - OTHER | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DRY MOUTH/SALIVARY GLAND (XEROSTOMIA) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPHAGIA (DIFFICULTY SWALLOWING) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHOIDS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - ABDOMEN NOS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - PELVIS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA: LIMB | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - CHEST/THORAX NOS | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - FACE | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - OTHER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RIGORS/CHILLS | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION - OTHER | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - DENTAL-TOOTH | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA) | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| BURN | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| FRACTURE | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTEREMIA) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| CREATININE | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| HEARING: PATIENTS WITH/WITHOUT BASELINE AUDIOGRAM AND ENROLLED IN A MONITORING PROGRAM | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMOGLOBIN | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| METABOLIC/LABORATORY - OTHER | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUTROPHILS/GRANULOCYTES (ANC/AGC) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| PLATELETS | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| POTASSIUM, SERUM-LOW (HYPOKALEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTRAOCULAR | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCULOSKELETAL/SOFT TISSUE - OTHER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| OSTEONECROSIS (AVASCULAR NECROSIS) | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - BACK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - BONE | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - EXTREMITY-LIMB | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - JOINT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - MUSCLE | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - NECK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ATAXIA (INCOORDINATION) | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY: SENSORY | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - HEAD/HEADACHE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - SINUS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SYNCOPE (FAINTING) | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| TASTE ALTERATION (DYSGEUSIA) | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MOOD ALTERATION - ANXIETY | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MOOD ALTERATION - DEPRESSION | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RENAL/GENITOURINARY - OTHER | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| URINARY FREQUENCY/URGENCY | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VAGINAL DRYNESS | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NASAL CAVITY/PARANASAL SINUS REACTIONS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - THROAT/PHARYNX/LARYNX | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY - OTHER | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DERMATOLOGY/SKIN - OTHER | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH: ACNE/ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SWEATING (DIAPHORESIS) | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Emotional Well-Beling Change from Baseline |
|
| Functional Well-Being Change from Baseline |
|
| FACT-G Change from Baseline |
|