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The purpose of this study is to evaluate the efficacy of once-daily Oral avatrombopagin subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic procedures, to evaluate the safety of short-term administration of avatrombopag and to evaluate the pharmacokinetics (PK) of E5501.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag | Drug | Avatrombopag first Dose 80 mg followed by 10 mg a day for up to 6 additional days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Response | Platelet counts (PC) were determined from blood draws. A responder is defined as a participant having an increase of at least 20,000/mm^3 PC from Baseline and a PC greater than 50,000/mm^3 at least once during Day 4 through Day 8. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (end of treatment (EOT)), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Day 8 (Visit 5, EOT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Platelet Count on Day 8 (Visit 5 and/or End of Treatment) From Baseline | Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. |
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Key Inclusion Criteria:
Males or females ≥ 18 years of age
Thrombocytopenia (defined as a platelet count ≥ 10,000 - ≤ 50,000 (+15%)/mm^3 )
Model for End-Stage Liver Disease (MELD) scores ≤ 24
Chronic liver diseases due to one of the following three etiologies:
Chronic Viral Hepatitis from one of the following categories
NASH diagnosed as:
Alcoholic liver disease diagnosed as:
Subjects who are scheduled to undergo an elective invasive procedure between 1 to 4 days post last dose of study drug.
Adequate renal function as evidenced by a calculated creatinine clearance ≥50 mL/minute per the Cockcroft and Gault formula
Life expectancy ≥3 months
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Jenkins | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: 20 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| FG001 | Cohort A: 40 mg Avatrombopag, 1G Formulation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Avatrombopag |
| Drug |
Avatrombopag first Dose 80 mg followed by 20 mg a day for 3 days and then Placebo for 3 additional days |
|
| Placebo | Drug | Placebo or inactive substance once a day for up to 7 days |
|
| Day 8 (Visit 5, EOT) |
| Percentage of Participants Experiencing Dose-response by Visit | Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Day 4 (Visit 3), Day 6 ( Visit 4), Day 8 (Visit 5, EOT), 3 Day Post Last Dose (Visit 6), and 7 Day Post Last Dose (Visit 7) |
| Percentage of Participants Who Achieved a Platelet Count Greater Than 75,000/mm^3 on Day 4 | Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Day 4 (Visit 3) |
| Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8 | Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Day 4 (Visit 3) and Day 8 (Visit 5, EOT) |
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| FG002 | Cohort A: 80 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| FG003 | Cohort A: Placebo, 1G Formulation | Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| FG004 | Cohort B: 0 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7. |
| FG005 | Cohort B: 20 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7. |
| FG006 | Cohort B: Placebo, 2G Formulation | Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent to Treat (ITT) population included all participants who were randomized into the study, received study medication, and had a post-treatment assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: 20 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| BG001 | Cohort A: 40 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| BG002 | Cohort A: 80 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| BG003 | Cohort A: Placebo, 1G Formulation | Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| BG004 | Cohort B: 10 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7. |
| BG005 | Cohort B: 20 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7. |
| BG006 | Cohort B: Placebo, 2G Formulation | Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Participants Experiencing Response | Platelet counts (PC) were determined from blood draws. A responder is defined as a participant having an increase of at least 20,000/mm^3 PC from Baseline and a PC greater than 50,000/mm^3 at least once during Day 4 through Day 8. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (end of treatment (EOT)), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Intent-to-treat (ITT) population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized. | Posted | Number | Percentage of participants | Day 8 (Visit 5, EOT) |
|
|
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Platelet Count on Day 8 (Visit 5 and/or End of Treatment) From Baseline | Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized. | Posted | Mean | Standard Deviation | K/mm^3 | Day 8 (Visit 5, EOT) |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Dose-response by Visit | Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized. | Posted | Number | Percentage of participants | Day 4 (Visit 3), Day 6 ( Visit 4), Day 8 (Visit 5, EOT), 3 Day Post Last Dose (Visit 6), and 7 Day Post Last Dose (Visit 7) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Platelet Count Greater Than 75,000/mm^3 on Day 4 | Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized. | Posted | Number | Percentage of participants | Day 4 (Visit 3) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8 | Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used. | Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized. | Posted | Number | Percentage of participants | Day 4 (Visit 3) and Day 8 (Visit 5, EOT) |
|
Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: 20 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. | 0 | 18 | 3 | 18 | 17 | 18 |
| EG001 | Cohort A: 40 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. | 0 | 16 | 2 | 16 | 13 | 16 |
| EG002 | Cohort A: 80 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. | 0 | 17 | 3 | 17 | 13 | 17 |
| EG003 | Cohort A: Placebo, 1G Formulation | Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. | 0 | 16 | 1 | 16 | 12 | 16 |
| EG004 | Cohort B: 10 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7. | 1 | 21 | 5 | 21 | 17 | 21 |
| EG005 | Cohort B: 20 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7. | 0 | 21 | 3 | 21 | 18 | 21 |
| EG006 | Cohort B: Placebo, 2G Formulation | Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. | 0 | 21 | 3 | 21 | 16 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Heamorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Peritonitis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Staphylcoccal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Cardiomegaly | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Colonic polyp | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Erosive duodenitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastric verices | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Intestinal polyp | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oesophageal mass | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Polyp colorectal | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Varices oesophageal | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinusitus | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Arthropid bite | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Iris injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Electrocardiogram T wave peaked | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mental status change | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Scrotal swelling | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary valve incompetence | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Faeces discolored | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai Inc. | 1-888-422-4743 |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| C533238 | avatrombopag |
Not provided
Not provided
Not provided
| Male |
|
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| No response |
|
| OG002 | Cohort A: 80 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| OG003 | Cohort A: Placebo, 1G Formulation | Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| OG004 | Cohort B: 10 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7. |
| OG005 | Cohort B: 20 mg Aavatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7. |
| OG006 | Cohort B: Placebo, 2G Formulation | Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
|
|
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| OG002 | Cohort A: 80 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| OG003 | Cohort A: Placebo, 1G Formulation | Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| OG004 | Cohort B: 10 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7. |
| OG005 | Cohort B: 20 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7. |
| OG006 | Cohort B: Placebo, 2G Formulation | Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
|
|
| OG002 | Cohort A: 80 mg Avatrombopag, IG Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| OG003 | Cohort A: Placebo, IG Formulation | Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| OG004 | Cohort B: 10 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7. |
| OG005 | Cohort B: 20 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7. |
| OG006 | Cohort B: Placebo, 2G Formulation | Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
|
|
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
| OG002 | Cohort A: 80 mg Avatrombopag, 1G Formulation | Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7. |
| OG003 | Cohort A: Placebo, 1G Formulation | Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
| OG004 | Cohort B: 10 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7. |
| OG005 | Cohort B: 20 mg Avatrombopag, 2G Formulation | Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7. |
| OG006 | Cohort B: Placebo, 2G Formulation | Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7. |
|
|