Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.
This is a phase IV, open-label safety study, designed to determine baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP)and to evaluate the long-term effect of eltrombopag on bone marrow reticulin and/or collagen fibers.
The duration of the screening period is up to 8 weeks. Eltrombopag will be administered for at least 2-years followed by a 4-week follow-up period. Bone marrow biopsies will be performed at screening, after 1-year and 2-years of eltrombopag treatment, and at early withdrawal of treatment. The screening bone marrow biopsy should be performed within 8 weeks of planned start of study medication and the bone marrow biopsy block must be available for central laboratory processing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | Oral eltrombopag once daily, starting dose 50 mg (or 25 mg for subjects of East Asian ancestry). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag olamine | Drug | Thrombopoietin receptor agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline | The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis [MF]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. | Baseline |
| Number of Participants With a Positive or Negative Collagen Level at Baseline | The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. | Baseline |
| Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Exception: Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | New York | New York | 10021 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25296772 | Derived | Wong RS, Bakshi K, Brainsky A. Thrombophilia in patients with chronic immune thrombocytopenia. Scand J Clin Lab Invest. 2015 Jan;75(1):13-7. doi: 10.3109/00365513.2014.962597. Epub 2014 Oct 9. |
Not provided
Not provided
A total of 167 participants were enrolled and received at least one dose of study medication. The 5 enrolled participants from center 082877 were excluded from the analysis due to the following: serious good clinical practice (GCP) findings related to informed consent, source documents and investigator study oversight.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eltrombopag | Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and 1 year |
| Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. | Baseline and 2 years |
| Number of Participants With a Positive or Negative Collagen Level at 1 Year | The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. | 1 year |
| Number of Participants With a Positive or Negative Collagen Level at 2 Year | The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. | 2 years |
| From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) |
| Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during. | From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; >1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; >30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations. | From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) |
| Hradec Králové |
| Czechia |
| GSK Investigational Site | Olomouc | 775 20 | Czechia |
| GSK Investigational Site | Prague | 128 08 | Czechia |
| GSK Investigational Site | Caen | 14033 | France |
| GSK Investigational Site | Créteil | 94010 | France |
| GSK Investigational Site | Pessac | 33604 | France |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81377 | Germany |
| GSK Investigational Site | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| GSK Investigational Site | Düsseldorf | North Rhine-Westphalia | 40479 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13353 | Germany |
| GSK Investigational Site | Shatin, New Territories | Hong Kong |
| GSK Investigational Site | Debrecen | 4012 | Hungary |
| GSK Investigational Site | Győr | 9023 | Hungary |
| GSK Investigational Site | Szeged | 6720 | Hungary |
| GSK Investigational Site | Ludhiana | 141008 | India |
| GSK Investigational Site | Pune | 411004 | India |
| GSK Investigational Site | Surat | 395002 | India |
| GSK Investigational Site | Vellore | 632004 | India |
| GSK Investigational Site | Bologna | Emilia-Romagna | 40138 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20132 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20162 | Italy |
| GSK Investigational Site | Padova | Veneto | 35128 | Italy |
| GSK Investigational Site | Vicenza | Veneto | 36100 | Italy |
| GSK Investigational Site | Karachi | 75300 | Pakistan |
| GSK Investigational Site | Lahore | 54600 | Pakistan |
| GSK Investigational Site | Moscow | 125167 | Russia |
| GSK Investigational Site | Novosibirsk | 630087 | Russia |
| GSK Investigational Site | Saint Petersburg | 193024 | Russia |
| GSK Investigational Site | Seongnam-si Gyeonggi-do | 463-712 | South Korea |
| GSK Investigational Site | Seoul | 135-710 | South Korea |
| GSK Investigational Site | Seoul | 137-701 | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eltrombopag | Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877. | Mean | Standard Deviation | Years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline | The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis [MF]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. | All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877. Participants with bone marrow biopsy data available in the relevant time period were included. | Posted | Number | Participants | Baseline |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Positive or Negative Collagen Level at Baseline | The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. | ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included. | Posted | Number | Participants | Baseline |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. | ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included. | Posted | Number | Participants | Baseline and 1 year |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. | ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included. | Posted | Number | Participants | Baseline and 2 years |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Positive or Negative Collagen Level at 1 Year | The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. | ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included. | Posted | Number | Participants | 1 year |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Positive or Negative Collagen Level at 2 Year | The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. | ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included. | Posted | Number | Participants | 2 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during. | ATS Population | Posted | Number | Participants | From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during. | ATS Population | Posted | Number | Participants | From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; >1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; >30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations. | ATS Population | Posted | Number | Participants | From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) |
|
On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
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 | Eltrombopag | Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response. | 42 | 162 | 114 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA |
| ||
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA |
| ||
| Vertigo | Ear and labyrinth disorders | MedDRA |
| ||
| Adrenal insufficiency | Endocrine disorders | MedDRA |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDRA |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA |
| ||
| Gastritis | Gastrointestinal disorders | MedDRA |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA |
| ||
| Gingival bleeding | Gastrointestinal disorders | MedDRA |
| ||
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA |
| ||
| Nausea | Gastrointestinal disorders | MedDRA |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA |
| ||
| Chest pain | General disorders | MedDRA |
| ||
| Fatigue | General disorders | MedDRA |
| ||
| Gait disturbance | General disorders | MedDRA |
| ||
| Local swelling | General disorders | MedDRA |
| ||
| Pyrexia | General disorders | MedDRA |
| ||
| Cholecystitis | Hepatobiliary disorders | MedDRA |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA |
| ||
| Cholecystitis infective | Infections and infestations | MedDRA |
| ||
| Dengue fever | Infections and infestations | MedDRA |
| ||
| Fungal infection | Infections and infestations | MedDRA |
| ||
| Gallbladder empyema | Infections and infestations | MedDRA |
| ||
| Lower respiratory tract infection | Infections and infestations | MedDRA |
| ||
| Pharyngitis | Infections and infestations | MedDRA |
| ||
| Pneumonia | Infections and infestations | MedDRA |
| ||
| Rash pustular | Infections and infestations | MedDRA |
| ||
| Sialoadenitis | Infections and infestations | MedDRA |
| ||
| Tooth abscess | Infections and infestations | MedDRA |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA |
| ||
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA |
| ||
| Procedural pain | Injury, poisoning and procedural complications | MedDRA |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA |
| ||
| Aspartate aminotransferase increased | Investigations | MedDRA |
| ||
| Blood bilirubin increased | Investigations | MedDRA |
| ||
| Hepatic enzyme increased | Investigations | MedDRA |
| ||
| Liver function test abnormal | Investigations | MedDRA |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA |
| ||
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA |
| ||
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA |
| ||
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA |
| ||
| Cerebral haemorrhage | Nervous system disorders | MedDRA |
| ||
| Cerebral venous thrombosis | Nervous system disorders | MedDRA |
| ||
| Headache | Nervous system disorders | MedDRA |
| ||
| Lethargy | Nervous system disorders | MedDRA |
| ||
| Transient ischaemic attack | Nervous system disorders | MedDRA |
| ||
| Transverse sinus thrombosis | Nervous system disorders | MedDRA |
| ||
| Depression | Psychiatric disorders | MedDRA |
| ||
| Psychosomatic disease | Psychiatric disorders | MedDRA |
| ||
| Menorrhagia | Reproductive system and breast disorders | MedDRA |
| ||
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Deep vein thrombosis | Vascular disorders | MedDRA |
| ||
| Haematoma | Vascular disorders | MedDRA |
| ||
| Haemorrhage | Vascular disorders | MedDRA |
| ||
| Thrombophlebitis | Vascular disorders | MedDRA |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA |
| ||
| Vertigo | Ear and labyrinth disorders | MedDRA |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDRA |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA |
| ||
| Dyspepsia | Gastrointestinal disorders | MedDRA |
| ||
| Gingival bleeding | Gastrointestinal disorders | MedDRA |
| ||
| Nausea | Gastrointestinal disorders | MedDRA |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA |
| ||
| Asthenia | General disorders | MedDRA |
| ||
| Fatigue | General disorders | MedDRA |
| ||
| Influenza like illness | General disorders | MedDRA |
| ||
| Pain | General disorders | MedDRA |
| ||
| Pyrexia | General disorders | MedDRA |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA |
| ||
| Viral infection | Infections and infestations | MedDRA |
| ||
| Contusion | Injury, poisoning and procedural complications | MedDRA |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA |
| ||
| Aspartate aminotransferase increased | Investigations | MedDRA |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDRA |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA |
| ||
| Dizziness | Nervous system disorders | MedDRA |
| ||
| Headache | Nervous system disorders | MedDRA |
| ||
| Menorrhagia | Reproductive system and breast disorders | MedDRA |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA |
| ||
| Purpura | Skin and subcutaneous tissue disorders | MedDRA |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA |
| ||
| Haematoma | Vascular disorders | MedDRA |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D011693 | Purpura |
| D011696 | Purpura, Thrombocytopenic |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Asian - South East Asian Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Missing |
|
| Title | Measurements |
|---|
|
| MF-3 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|