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This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are > 50,000.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Romiplostim |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romiplostim | Biological | Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once | Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Response (Definition 1) | Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L | Duration of treatment (up to 201 weeks) |
| Platelet Response (Definition 2) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26066765 | Background | Janssens A, Tarantino M, Bird RJ, Mazzucconi MG, Boccia RV, Fernandez MF, Kozak T, Steurer M, Boekhorst Pt, Dillingham K, Kreuzbauer G, Woodard P. Romiplostim Treatment in Adults with Immune Thrombocytopenia of Varying Duration and Severity. Acta Haematol. 2015;134(4):215-28. doi: 10.1159/000381657. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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First Subject Enrolled: 24Feb2005 Last Subject Enrolled: 05Jan2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Romiplostim (AMG 531) Cohort 1 | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg. |
| FG001 | Romiplostim (AMG 531) Cohort 2 | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Romiplostim (AMG 531) Cohort 1 | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg. |
| BG001 | Romiplostim (AMG 531) Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Adverse Events | One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once | Safety Analysis Set, comprised of all participants who received at least one dose of romiplostim | Posted | Number | participants | Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. |
|
Average duration: cohort 1 52 wks; cohort 2 42 wks.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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 | Romiplostim Cohort 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D013921 | Thrombocytopenia |
| D011696 | Purpura, Thrombocytopenic |
| C537560 | Jacobs syndrome |
| D006402 | Hematologic Diseases |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
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| ID | Term |
|---|---|
| C488777 | romiplostim |
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|
Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)
| Duration of treatment (up to 201 weeks) |
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| Noncompliance |
|
| Requirement for alternative therapy |
|
| Protocol-specified Criteria |
|
Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg. |
|
|
| Secondary | Platelet Response (Definition 1) | Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L | Full Analysis Set, all enrolled participants | Posted | Number | Participants | Duration of treatment (up to 201 weeks) |
|
|
|
| Secondary | Platelet Response (Definition 2) | Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline) | Full Analysis Set, all enrolled participants | Posted | Number | Participants | Duration of treatment (up to 201 weeks) |
|
|
|
| 61 |
| 168 |
| 155 |
| 168 |
| EG001 | Romiplostim Cohort 2 | 61 | 239 | 188 | 239 |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bone marrow disorder | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bone marrow reticulin fibrosis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intestinal infarction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| No therapeutic response | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Polyp | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Fungal sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| H1N1 influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Infected cyst | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Stab wound | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Blood smear test abnormal | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Electrocardiogram | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Platelet count abnormal | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Juvenile melanoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mononeuropathy multiplex | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Temporal lobe epilepsy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urogenital haemorrhage | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pemphigus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |