Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Eltrombopag oral tablets once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag oral tablets | Drug | Eltrombopag oral tablets once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment. | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L | Platelet counts were measured by blood draw. | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 | Gifu | 503-8502 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23896965 | Derived | Katsutani S, Tomiyama Y, Kimura A, Miyakawa Y, Okamoto S, Okoshi Y, Ninomiya H, Kosugi H, Ishii K, Ikeda Y, Hattori T, Katsura K, Kanakura Y. Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia: an open-label, extension study. Int J Hematol. 2013 Sep;98(3):323-30. doi: 10.1007/s12185-013-1401-1. Epub 2013 Jul 30. |
Not provided
Not provided
This study is an open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for the treatment of participants with idiopathic thrombocytopenic purpura (ITP) who had previously been enrolled in eltrombopag trial TRA108109 (NCT00540423).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eltrombopag | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eltrombopag | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| 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 | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment. | Safety Population (SP): all participants who received at least one dose of study medication | Posted | Number | participants | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
|
Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
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 | Eltrombopag | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C520809 | eltrombopag |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Median Platelet Counts | Platelet counts were measured by blood draw. | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
| Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.) | Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count. | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
| Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals | Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count. | 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks) |
| Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s). | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
| Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication | Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration. | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
| Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy | Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy. | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
| Hiroshima |
| 734-8551 |
| Japan |
| GSK Investigational Site | Ibaraki | 305-8576 | Japan |
| GSK Investigational Site | Osaka | 565-0871 | Japan |
| GSK Investigational Site | Osaka | 596-8501 | Japan |
| GSK Investigational Site | Tokyo | 160-8582 | Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
|
|
| Secondary | Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L | Platelet counts were measured by blood draw. | Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants. | Posted | Number | percentage of participants | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
|
|
|
| Secondary | Median Platelet Counts | Platelet counts were measured by blood draw. | FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants. | Posted | Median | Full Range | Gi/L | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
|
|
|
| Secondary | Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.) | Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count. | FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants. | Posted | Number | percentage of participants | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
|
|
|
| Secondary | Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals | Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count. | FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants. | Posted | Median | Full Range | weeks | 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks) |
|
|
|
| Secondary | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s). | FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants. | Posted | Number | percentage of participants | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
|
|
|
| Secondary | Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication | Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration. | FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis. | Posted | Number | percentage of participants | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
|
|
|
| Secondary | Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy | Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy. | FAS | Posted | Number | percentage of participants | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
|
|
|
| 6 |
| 19 |
| 19 |
| 19 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cystitis-like symptom | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Presbyacusis | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lip neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
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.
| 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 |
| Title | Measurements |
|---|---|
|
| Week 3, n=19 |
|
| Week 4, n=19 |
|
| Week 8, n=19 |
|
| Week 12, n=16 |
|
| Week 16, n=17 |
|
| Week 20, n=15 |
|
| Week 24, n=17 |
|
| Week 28, n=16 |
|
| Week 32, n=16 |
|
| Week 36, n=18 |
|
| Week 40, n=17 |
|
| Week 44, n=17 |
|
| Week 48, n=18 |
|
| Week 52, n=16 |
|
| Week 56, n=14 |
|
| Week 60, n=16 |
|
| Week 64, n=14 |
|
| Week 68, n=14 |
|
| Week 72, n=12 |
|
| Week 76, n=12 |
|
| Week 80, n=12 |
|
| Week 84, n=13 |
|
| Week 88, n=12 |
|
| Week 92, n=11 |
|
| Week 96, n=11 |
|
| Week 100, n=13 |
|
| Week 104, n=11 |
|
| Week 108, n=11 |
|
| Week 112, n=7 |
|
| Week 116, n=7 |
|
| Week 120, n=5 |
|
| Week 124, n=6 |
|
| Week 128, n=4 |
|
| Week 132, n=2 |
|
| Week 136, n=1 |
|
| Last Visit/Early Withdrawal Visit, n=19 |
|
| Title | Measurements |
|---|---|
|
| Week 3, n=19 |
|
| Week 4, n=19 |
|
| Week 8, n=19 |
|
| Week 12, n=16 |
|
| Week 16, n=17 |
|
| Week 20, n=15 |
|
| Week 24, n=17 |
|
| Week 28, n=16 |
|
| Week 32, n=16 |
|
| Week 36, n=18 |
|
| Week 40, n=17 |
|
| Week 44, n=17 |
|
| Week 48, n=18 |
|
| Week 52, n=16 |
|
| Week 56, n=14 |
|
| Week 60, n=16 |
|
| Week 64, n=14 |
|
| Week 68, n=14 |
|
| Week 72, n=12 |
|
| Week 76, n=12 |
|
| Week 80, n=12 |
|
| Week 84, n=13 |
|
| Week 88, n=12 |
|
| Week 92, n=11 |
|
| Week 96, n=11 |
|
| Week 100, n=13 |
|
| Week 104, n=11 |
|
| Week 108, n=11 |
|
| Week 112, n=7 |
|
| Week 116, n=7 |
|
| Week 120, n=5 |
|
| Week 124, n=6 |
|
| Week 128, n=4 |
|
| Week 132, n=2 |
|
| Week 136, n=1 |
|
| Last Visit/Early Withdrawal Visit, n=19 |
|
| Title | Measurements |
|---|---|
|
| Study Med. =<52 WKS, MCW >=7 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=10 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=13 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=16 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=19 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=22 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=25 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=28 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=31 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=34 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=37 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=40 WKS, n=2 |
|
| Study Med. =<52 WKS, MCW >=43 WKS, n=2 |
|
| Study Med. >52 to =<78 WKS, MCW=0 WK, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=1 WK, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=4 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=7 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=10 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=13 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=16 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=19 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=22 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=25 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=28 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=31 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=34 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=37 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=40 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=43 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=52 WKS, n=1 |
|
| Study Med. >52 to =<78 WKS, MCW >=65 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW=0 WK, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=1 WK, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=4 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=7 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=10 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=13 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=16 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=19 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=22 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=25 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=28 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=31 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=34 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=37 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=40 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=43 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=52 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=65 WKS, n=1 |
|
| Study Med. >78 to =<104 WKS, MCW >=78 WKS, n=1 |
|
| Study Med. >104 to =<130 WKS, MCW=0 WK, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=1 WK, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=4 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=7 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=10 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=13 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=16 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=19 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=22 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=25 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=28 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=31 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=34 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=37 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=40 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=43 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=52 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=65 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=78 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=91 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=104 WKS, n=11 |
|
| Study Med. >104 to =<130 WKS, MCW >=117 WKS, n=6 |
|
| Study Med. >130 WKS, MCW=0 WK, n=4 |
|
| Study Med. >130 WKS, MCW >=1 WK, n=4 |
|
| Study Med. >130 WKS, MCW >=4 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=7 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=10 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=13 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=16 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=19 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=22 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=25 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=28 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=31 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=34 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=37 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=40 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=43 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=52 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=65 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=78 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=91 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=104 WKS, n=4 |
|
| Study Med. >130 WKS, MCW >=117 WKS, n=4 |
|
| Total, MCW=0 WK, n=19 |
|
| Total, MCW >=1 WK, n=19 |
|
| Total, MCW >=4 WKS, n=19 |
|
| Total, MCW >=7 WKS, n=19 |
|
| Total, MCW >=10 WKS, n=19 |
|
| Total, MCW >=13 WKS, n=19 |
|
| Total, MCW >=16 WKS, n=19 |
|
| Total, MCW >=19 WKS, n=19 |
|
| Total, MCW >=22 WKS, n=19 |
|
| Total, MCW >=25 WKS, n=19 |
|
| Total, MCW >=28 WKS, n=19 |
|
| Total, MCW >=31 WKS, n=19 |
|
| Total, MCW >=34 WKS, n=19 |
|
| Total, MCW >=37 WKS, n=19 |
|
| Total, MCW >=40 WKS, n=19 |
|
| Total, MCW >=43 WKS, n=19 |
|
| Total, MCW >=52 WKS, n=17 |
|
| Total, MCW >=65 WKS, n=17 |
|
| Total, MCW >=78 WKS, n=16 |
|
| Total, MCW >=91 WKS, n=15 |
|
| Total, MCW >=104 WKS, n=15 |
|
| Total, MCW >=117 WKS, n=10 |
|
| Title | Measurements |
|---|---|
|
| 9 Months (39 Weeks), n=19 |
|
| 12 Months (52 Weeks), n=17 |
|
| 15 Months (65 Weeks), n=17 |
|
| 18 Months (78 Weeks), n=16 |
|
| 21 Months (91 Weeks), n=15 |
|
| 24 Months (104 Weeks), n=15 |
|
| 27 Months (117 Weeks), n=10 |
|
| 30 Months (130 Weeks), n=4 |
|
| Title | Measurements |
|---|---|
|
| Week 3, n=19 |
|
| Week 4, n=19 |
|
| Week 8, n=19 |
|
| Week 12, n=16 |
|
| Week 16, n=17 |
|
| Week 20, n=15 |
|
| Week 24, n=17 |
|
| Week 28, n=16 |
|
| Week 32, n=16 |
|
| Week 36, n=18 |
|
| Week 40, n=17 |
|
| Week 44, n=17 |
|
| Week 48, n=18 |
|
| Week 52, n=16 |
|
| Week 56, n=14 |
|
| Week 60, n=16 |
|
| Week 64, n=14 |
|
| Week 68, n=14 |
|
| Week 72, n=12 |
|
| Week 76, n=12 |
|
| Week 80, n=12 |
|
| Week 84, n=13 |
|
| Week 88, n=12 |
|
| Week 92, n=11 |
|
| Week 96, n=11 |
|
| Week 100, n=13 |
|
| Week 104, n=11 |
|
| Week 108, n=11 |
|
| Week 112, n=7 |
|
| Week 116, n=7 |
|
| Week 120, n=5 |
|
| Week 124, n=6 |
|
| Week 128, n=4 |
|
| Week 132, n=2 |
|
| Week 136, n=1 |
|
| Last Visit/Early Withdrawal, n=19 |
|
| Title | Measurements |
|---|---|
|
| Platelet Transfusion |
|
| Splenectomy |
|