Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01HL072268 | U.S. NIH Grant/Contract | View source | |
| HL072268 | |||
| HL072033 | |||
| HL072291 | |||
| HL072196 | |||
| HL072289 | |||
| HL072248 | |||
| HL072191 | |||
| HL072299 | |||
| HL072305 | |||
| HL072274 | |||
| HL072028 | |||
| HL072359 | |||
| HL072072 | |||
| HL072355 | |||
| HL072283 | |||
| HL072346 | |||
| HL072331 | |||
| HL072290 |
Not provided
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The study was closed due to accrual futility there were only a total of 8 subjects enrolled.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
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This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with prednisone.
ITP is a common disorder associated with significant morbidity. For more than 40 years it has been recognized that this disorder was responsive to corticosteroid therapy. As corticosteroids are easily obtainable and inexpensive, they have become the standard first-line therapy for adult patients with newly-diagnosed ITP. Generally, patients are treated with prednisone at a dose of approximately 1 mg/kg, or 60 mg/day, and once a response is obtained the daily dosage is gradually tapered. While approximately 70% of patients treated in this manner respond initially, most will relapse as the corticosteroid dose is lowered; ultimately only 15-20% of patients achieve a complete or partial remission of their ITP at an "acceptable" dose of prednisone. Recently, several studies have suggested that the use of high dose corticosteroids, specifically pulse dexamethasone, may be a more efficacious initial therapy for ITP, capable of causing a higher initial response rate and a significantly longer duration of remission despite a shorter course of initial therapy.
This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with standard oral corticosteroids. This may reflect the ability of high dose corticosteroids to eradicate a sensitive pathogenic lymphoid clone that may be transiently susceptible to aggressive immunosuppressive therapy early in the course of disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose pulse dexamethasone | Experimental |
| |
| Standard prednisone therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone USP Micronized | Drug | The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry. | From 60 days through 365 days after study entry. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry | From 60 days through 365 days after study entry | |
| The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan F Assmann, PhD | Carelon Research | Principal Investigator |
| James Bussel, MD | Weill Medical College, Cornell University | Principal Investigator |
| Alvin Schmaier, MD | Case Western Reserve University | Principal Investigator |
| Jodi Segal, MD | Johns Hopkins University | Principal Investigator |
| Terry Gernsheimer, MD | University of Washington | Principal Investigator |
| Eliot Williams, MD | University of Wisconsin, Madison | Principal Investigator |
| Ellis Neufeld, MD | Boston Children's Hospital | Principal Investigator |
| Judith Lin, MD | Brigham and Women's Hospital | Principal Investigator |
| Thomas Ortel, MD | Duke University | Principal Investigator |
| David Kuter, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University | New Orleans | Louisiana | 70112 | United States | ||
| University of Maryland |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Pulse Dexamethasone | Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Prednisone | Drug | Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding. |
|
| 365 days after study entry |
| The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry | From 180 days through 365 days after study entry |
| The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry | From 180 days through 365 days after study entry |
| The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry | Through 60 days after study entry |
| The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry | From 60 days through 365 days after study entry |
| The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.) | From 60 days through 365 days after study entry |
| The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.) | From 60 days through 365 days after study entry |
| The Percentage of Patients Undergoing Splenectomy | Through 365 days after study entry |
| Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey | Weeks 4, 8, and 52 after study entry |
| The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score | Through 365 days after study entry |
| The Percentage of Patients Not Completing Study Therapy | 49 days after study entry |
| The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy | Through 1 year after study entry |
| Massachusetts General Hospital |
| Principal Investigator |
| Cindy Leissinger, MD | Tulane University | Principal Investigator |
| Ann Zimrin, MD | University of Maryland | Principal Investigator |
| Nigel Key, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| James George, MD | The University of Oklahoma | Principal Investigator |
| Michele Lambert, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Joseph Kiss, MD | University of Pittsburgh | Principal Investigator |
| Bruce Sachais, MD, PhD | University of Pennsylvania | Principal Investigator |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| Weill Medical College, Cornell University | New York | New York | 10021 | United States |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27514 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Presbyterian and Shadyside Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Gundersen Clinic | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Standard Prednisone Therapy |
Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Pulse Dexamethasone | Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules. |
| BG001 | Standard Prednisone Therapy | Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding. |
| 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 |
| ||||||||||||||||||
| 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 Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry. | Posted | Number | percentage of subjects | From 60 days through 365 days after study entry. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | From 60 days through 365 days after study entry |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365 | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | 365 days after study entry |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | From 180 days through 365 days after study entry |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | From 180 days through 365 days after study entry |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | Through 60 days after study entry |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | From 60 days through 365 days after study entry |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.) | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | From 60 days through 365 days after study entry |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.) | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | From 60 days through 365 days after study entry |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Undergoing Splenectomy | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | Through 365 days after study entry |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | Weeks 4, 8, and 52 after study entry |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | Through 365 days after study entry |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Not Completing Study Therapy | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | 49 days after study entry |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy | Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed. | Posted | Through 1 year after study entry |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose Pulse Dexamethasone | Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules. | 3 | 5 | 5 | 5 | ||
| EG001 | Standard Prednisone Therapy | Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding. | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse drug reaction | General disorders |
| |||
| Gingival bleeding | Gastrointestinal disorders |
| |||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Increased tendency to bruise | Skin and subcutaneous tissue disorders |
| |||
| Laceration | Injury, poisoning and procedural complications |
| |||
| Occult blood | Investigations |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Tibia fracture | Injury, poisoning and procedural complications |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| |||
| Abnormal weight gain | Metabolism and nutrition disorders |
| |||
| Agitation | Psychiatric disorders |
| |||
| Alopecia | Skin and subcutaneous tissue disorders |
| |||
| Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders |
| |||
| Anal haemorrhage | Gastrointestinal disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Appetite disorder | Metabolism and nutrition disorders |
| |||
| Application site bleeding | General disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Blood blister | Skin and subcutaneous tissue disorders |
| |||
| Bone pain | Musculoskeletal and connective tissue disorders |
| |||
| Breast enlargement | Reproductive system and breast disorders |
| |||
| Bronchitis | Infections and infestations |
| |||
| Chest pain | General disorders |
| |||
| Conjunctival haemorrhage | Eye disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Cushingoid | Endocrine disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Depressed mood | Psychiatric disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dry skin | Skin and subcutaneous tissue disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Ear pain | Ear and labyrinth disorders |
| |||
| Ecchymosis | Skin and subcutaneous tissue disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Eye pain | Eye disorders |
| |||
| Face oedema | General disorders |
| |||
| Fat tissue increased | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Feeling jittery | General disorders |
| |||
| Flushing | Vascular disorders |
| |||
| Gingival bleeding | Gastrointestinal disorders |
| |||
| Haematuria | Renal and urinary disorders |
| |||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders |
| |||
| Haemorrhoids | Gastrointestinal disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Hyperhidrosis | Skin and subcutaneous tissue disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Increased appetite | Metabolism and nutrition disorders |
| |||
| Increased tendency to bruise | Skin and subcutaneous tissue disorders |
| |||
| Influenza | Infections and infestations |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Joint swelling | Musculoskeletal and connective tissue disorders |
| |||
| Libido decreased | Psychiatric disorders |
| |||
| Malaise | General disorders |
| |||
| Male sexual dysfunction | Reproductive system and breast disorders |
| |||
| Menorrhagia | Reproductive system and breast disorders |
| |||
| Menstruation irregular | Reproductive system and breast disorders |
| |||
| Migraine | Nervous system disorders |
| |||
| Mood swings | Psychiatric disorders |
| |||
| Mouth haemorrhage | Gastrointestinal disorders |
| |||
| Mouth ulceration | Gastrointestinal disorders |
| |||
| Mucosal haemorrhage | General disorders |
| |||
| Muscular weakness | Musculoskeletal and connective tissue disorders |
| |||
| Nail discomfort | Skin and subcutaneous tissue disorders |
| |||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Night sweats | Skin and subcutaneous tissue disorders |
| |||
| Nightmare | Psychiatric disorders |
| |||
| Non-cardiac chest pain | General disorders |
| |||
| Occult blood | Investigations |
| |||
| Oedema | General disorders |
| |||
| Oil acne | Skin and subcutaneous tissue disorders |
| |||
| Onycholysis | Skin and subcutaneous tissue disorders |
| |||
| Oral disorder | Gastrointestinal disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Palpitations | Cardiac disorders |
| |||
| Petechiae | Skin and subcutaneous tissue disorders |
| |||
| Pharyngitis | Infections and infestations |
| |||
| Poor quality sleep | Nervous system disorders |
| |||
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| Pyrexia | General disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Restlessness | Psychiatric disorders |
| |||
| Scleral haemorrhage | Eye disorders |
| |||
| Seborrhoea | Skin and subcutaneous tissue disorders |
| |||
| Skin discolouration | Skin and subcutaneous tissue disorders |
| |||
| Skin disorder | Skin and subcutaneous tissue disorders |
| |||
| Skin reaction | Skin and subcutaneous tissue disorders |
| |||
| Swelling | General disorders |
| |||
| Swelling face | Skin and subcutaneous tissue disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Thirst | General disorders |
| |||
| Tremor | Nervous system disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Viral upper respiratory tract | Infections and infestations |
| |||
| Vision blurred | Eye disorders |
| |||
| Visual acuity reduced | Eye disorders |
| |||
| Visual impairment | Eye disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Weight fluctuation | Metabolism and nutrition disorders |
| |||
| Compensatory sweating | Injury, poisoning and procedural complications |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Menstrual cycle management | Surgical and medical procedures |
| |||
| Skin discomfort | Skin and subcutaneous tissue disorders |
| |||
| Paronychia | Infections and infestations |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan F. Assmann, PhD | New England Research Institutes, Inc. | 617-923-7747 | 548 | sassmann@neriscience.com |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| Participants |
|