Trial Outcomes & Findings for Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003 (NCT NCT00625443)
NCT ID: NCT00625443
Last Updated: 2018-03-16
Results Overview
A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of study drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. Related AEs included those whose relationship was categorized as possible or probably by the investigator. Dose interruption includes dose decreased, dose previously stopped, permanently stopped, or temporarily stopped. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.
Results posted on
2018-03-16
Participant Flow
After Protocol Amendment 4, this study implemented a flexible dose regimen and was considered to have an open-label, uncontrolled, single-arm design. Due to these limitations in study design, a single grouping method with 3 subgroups was implemented for reporting participant disposition.
Participant milestones
| Measure |
Lower 1/3 Avatromboopag Dose Group
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
26
|
15
|
|
Overall Study
COMPLETED
|
10
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
11
|
5
|
Reasons for withdrawal
| Measure |
Lower 1/3 Avatromboopag Dose Group
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
0
|
|
Overall Study
Non-compliance with protocol
|
0
|
1
|
0
|
|
Overall Study
Platelet count increase >=500,000/mm3
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
4
|
2
|
|
Overall Study
Other
|
0
|
1
|
1
|
Baseline Characteristics
Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003
Baseline characteristics by cohort
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=12 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=26 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
n=15 Participants
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 21.09 • n=5 Participants
|
52.5 Years
STANDARD_DEVIATION 18.44 • n=7 Participants
|
50.4 Years
STANDARD_DEVIATION 15.65 • n=5 Participants
|
50.1 Years
STANDARD_DEVIATION 18.25 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.Population: Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of study drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. Related AEs included those whose relationship was categorized as possible or probably by the investigator. Dose interruption includes dose decreased, dose previously stopped, permanently stopped, or temporarily stopped. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=12 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=26 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
n=15 Participants
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs
|
12 Participants
|
24 Participants
|
14 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Severe (Grade 3-4) TEAEs
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-related TEAEs
|
5 Participants
|
15 Participants
|
7 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAEs
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious treatment-related TEAEs
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Withdrawal of study drug due to TEAE
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Dose interruption due to TEAE
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.Population: Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=12 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=26 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
n=15 Participants
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Thrombocytopenia
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Splenomegaly
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Haemorrhagic diathesis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Idiopathic thrombocytopenic purpura
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Leukocytosis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Mitral valve incompetence
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Diarrhoea
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Vomiting
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Fatigue
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Oedema peripheral
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Asthenia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Chest pain
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Pyrexia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Platelet count increased
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Platelet count decreased
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Hyperuricaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Back pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Dizziness
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Hypoaesthesia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Cerebrovascular accident
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Haemorrhage intercranial
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Epistaxis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Hypotension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severe (Grade 3 or 4) TEAEs
Pelvic venous thrombosis
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.Population: Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
Drug-related TEAEs included those whose relationship was categorized as possible or probably by the investigator. A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=12 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=26 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
n=15 Participants
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Incidence of Drug-Related TEAEs
Thrombocytopenia
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Splenomegaly
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Anaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Leukocytosis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Vision blurred
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Visual disturbance
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Nausea
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Drug-Related TEAEs
Abdominal pain upper
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Diarrhoea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Vomiting
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Fatigue
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Oedema peripheral
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Platelet count increased
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Platelet count decreased
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Hyperlipidaemia
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Decreased appetite
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Arthralgia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Back pain
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Drug-Related TEAEs
Pain in extremity
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Arthropathy
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Muscular weakness
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Headache
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Dizziness
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Hypoaesthesia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Mood swings
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Haematuria
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Menorrhagia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Dyspnoea
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Drug-Related TEAEs
Epistaxis
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Nasal congestion
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Drug-Related TEAEs
Rash
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4Population: Full analysis set (FAS) included all participants who completed 501-CL-003 and received study drug in the current study, except baseline values and ITP-directed medications taken during the 2-week period before the first dose of avatrombopag in the current study. Data was summarized using the observed case (OC) method.
Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) "Responders", participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm\^3 and increased to greater than or equal to 50,000/mm\^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm3 but less than 50,000/mm\^3 and increased to a PC greater than or equal to 20,000/mm\^3 above their pretreatment values and 2) "Nonresponders", participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly.
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=25 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=28 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Median Platelet Counts at Selected Analysis Timepoints
Day 1
|
55.0 Platelets x 1000/mm^3
Interval 7.0 to 316.0
|
23.5 Platelets x 1000/mm^3
Interval 8.0 to 240.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 2
|
126.0 Platelets x 1000/mm^3
Interval 39.0 to 855.0
|
54.5 Platelets x 1000/mm^3
Interval 5.0 to 1207.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 4
|
113.0 Platelets x 1000/mm^3
Interval 8.0 to 489.0
|
38.0 Platelets x 1000/mm^3
Interval 6.0 to 383.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 6
|
104.0 Platelets x 1000/mm^3
Interval 18.0 to 880.0
|
47.0 Platelets x 1000/mm^3
Interval 10.0 to 731.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 8
|
137.0 Platelets x 1000/mm^3
Interval 13.0 to 571.0
|
45.5 Platelets x 1000/mm^3
Interval 3.0 to 263.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 10
|
85.5 Platelets x 1000/mm^3
Interval 32.0 to 179.0
|
72.0 Platelets x 1000/mm^3
Interval 9.0 to 702.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 12
|
88.0 Platelets x 1000/mm^3
Interval 4.0 to 293.0
|
72.0 Platelets x 1000/mm^3
Interval 2.0 to 557.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 14
|
84.0 Platelets x 1000/mm^3
Interval 29.0 to 296.0
|
77.5 Platelets x 1000/mm^3
Interval 9.0 to 368.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 16
|
143.0 Platelets x 1000/mm^3
Interval 45.0 to 395.0
|
46.0 Platelets x 1000/mm^3
Interval 3.0 to 273.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 18
|
119.0 Platelets x 1000/mm^3
Interval 28.0 to 303.0
|
78.0 Platelets x 1000/mm^3
Interval 17.0 to 382.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 20
|
92.0 Platelets x 1000/mm^3
Interval 39.0 to 322.0
|
68.0 Platelets x 1000/mm^3
Interval 18.0 to 481.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 22
|
109.0 Platelets x 1000/mm^3
Interval 26.0 to 354.0
|
78.5 Platelets x 1000/mm^3
Interval 14.0 to 502.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Week 24
|
154.0 Platelets x 1000/mm^3
Interval 28.0 to 335.0
|
66.0 Platelets x 1000/mm^3
Interval 19.0 to 368.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Follow-up Week 1
|
59.0 Platelets x 1000/mm^3
Interval 8.0 to 495.0
|
40.0 Platelets x 1000/mm^3
Interval 23.0 to 365.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Follow-up Week 2
|
25.0 Platelets x 1000/mm^3
Interval 6.0 to 86.0
|
22.0 Platelets x 1000/mm^3
Interval 8.0 to 426.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Follow-up Week 3
|
27.0 Platelets x 1000/mm^3
Interval 3.0 to 380.0
|
36.0 Platelets x 1000/mm^3
Interval 14.0 to 791.0
|
—
|
|
Median Platelet Counts at Selected Analysis Timepoints
Follow-up Week 4
|
35.0 Platelets x 1000/mm^3
Interval 15.0 to 331.0
|
28.0 Platelets x 1000/mm^3
Interval 1.0 to 881.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4Population: FAS. Data was summarized using the OC method.
Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) "Responders", participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm\^3 and increased to greater than or equal to 50,000/mm\^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm\^3 but less than 50,000/mm\^3 and increased to a PC greater than or equal to 20,000/mm\^3 above their pretreatment values and 2) "Nonresponders", participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly.
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=25 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=28 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Week 2
|
59.1 Percentage of participants
|
25.0 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Week 4
|
58.3 Percentage of participants
|
18.5 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Week 8
|
52.4 Percentage of participants
|
15.4 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Week 12
|
42.9 Percentage of participants
|
35.0 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Week 16
|
63.6 Percentage of participants
|
17.6 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Week 20
|
40.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Week 24
|
71.4 Percentage of participants
|
35.3 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Follow up Week 1
|
18.2 Percentage of participants
|
27.3 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Follow up Week 2
|
0 Percentage of participants
|
33.3 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Follow up Week 3
|
25.0 Percentage of participants
|
11.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit
Follow up Week 4
|
23.1 Percentage of participants
|
13.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4Population: FAS. Data was summarized using the OC method.
Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) "Responders", participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm\^3 and increased to greater than or equal to 50,000/mm\^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm\^3 but less than 50,000/mm\^3 and increased to a PC greater than or equal to 20,000/mm\^3 above their pretreatment values and 2) "Nonresponders", participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly.
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=25 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=28 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Percentage of Participants Who Maintained a Platelet Count of 100,000/mm^3 or Higher by Response Status
|
32.0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4Population: FAS. Data was summarized using the OC method.
Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) "Responders", participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm\^3 and increased to greater than or equal to 50,000/mm\^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm\^3 but less than 50,000/mm\^3 and increased to a PC greater than or equal to 20,000/mm\^3 above their pretreatment values and 2) "Nonresponders", participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly.
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=25 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=28 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Week 2
|
86.4 Percentage of participants
|
53.6 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Week 4
|
79.2 Percentage of participants
|
44.4 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Week 8
|
90.5 Percentage of participants
|
46.2 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Week 12
|
85.7 Percentage of participants
|
65.0 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Week 16
|
81.8 Percentage of participants
|
47.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Week 20
|
90.0 Percentage of participants
|
66.7 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Week 24
|
81.0 Percentage of participants
|
70.6 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Follow up Week 1
|
54.5 Percentage of participants
|
45.5 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Follow up Week 2
|
10.0 Percentage of participants
|
33.3 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Follow up Week 3
|
41.7 Percentage of participants
|
44.4 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit
Follow up Week 4
|
38.5 Percentage of participants
|
33.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4Population: FAS. Data was summarized using the OC method.
Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) "Responders", participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm\^3 and increased to greater than or equal to 50,000/mm\^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm\^3 but less than 50,000/mm\^3 and increased to a PC greater than or equal to 20,000/mm\^3 above their pretreatment values and 2) "Nonresponders", participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly.
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=25 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=28 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Percentage of Participants Who Maintained Response-Level Platelet Count
|
56.0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4Population: FAS. Data was summarized using the OC method.
Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) "Responders", participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm\^3 and increased to greater than or equal to 50,000/mm\^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm\^3 but less than 50,000/mm\^3 and increased to a PC greater than or equal to 20,000/mm\^3 above their pretreatment values and 2) "Nonresponders", participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly.
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=25 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=28 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Durable, Transient, or Overall Platelet Response
Durable Platelet Response
|
72.0 Percentage of participants
|
35.7 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Durable, Transient, or Overall Platelet Response
Transient Platelet Response
|
16.0 Percentage of participants
|
28.6 Percentage of participants
|
—
|
|
Percentage of Participants Who Achieved a Durable, Transient, or Overall Platelet Response
Overall Response
|
88.0 Percentage of participants
|
64.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through last 8 weeks of the Treatment PeriodPopulation: FAS. Data was summarized using the OC method. Only those participants who had data available at both Baseline and post-Baseline were analyzed.
A participant who used steroids at study entry was considered to have permanently discontinued steroid use if they had no steroid use during the last 8 weeks of the study Treatment Period. A participant who used steroids at study entry was considered to have decreased concomitant steroid medication by at least 50% if they permanently discontinued steroids, or in no dose of steroid was higher than 50% of their baseline steroid dose during the last 8 weeks of the study Treatment Period.
Outcome measures
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=24 Participants
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=24 Participants
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Number of Participants With Changes in Concomitant Steroid Use
Permanently Discontinued
|
4 Number of participants
|
4 Number of participants
|
—
|
|
Number of Participants With Changes in Concomitant Steroid Use
Decreased by greater than or equal to 50%
|
7 Number of participants
|
6 Number of participants
|
—
|
Adverse Events
Lower 1/3 Avatrombopag Dose Group
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Middle 1/3 Avatrombopag Dose Group
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Upper 1/3 Avatrombopag Dose Group
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=12 participants at risk
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=26 participants at risk
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
n=15 participants at risk
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
13.3%
2/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
Other adverse events
| Measure |
Lower 1/3 Avatrombopag Dose Group
n=12 participants at risk
Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Middle 1/3 Avatrombopag Dose Group
n=26 participants at risk
Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
Upper 1/3 Avatrombopag Dose Group
n=15 participants at risk
Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
11.5%
3/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
26.7%
4/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
11.5%
3/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
20.0%
3/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
13.3%
2/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
20.0%
3/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
13.3%
2/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
11.5%
3/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
General disorders
Fatigue
|
41.7%
5/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
15.4%
4/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
26.7%
4/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
20.0%
3/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
General disorders
Oedema
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Investigations
Platelet count increased
|
16.7%
2/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
11.5%
3/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
16.7%
2/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
11.5%
3/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
13.3%
2/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
13.3%
2/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
26.9%
7/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
20.0%
3/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
13.3%
2/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
7.7%
2/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
2/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
15.4%
4/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
20.0%
3/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
20.0%
3/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
11.5%
3/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
0.00%
0/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
25.0%
3/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
13.3%
2/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.3%
1/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
3.8%
1/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
6.7%
1/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
3/12 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
11.5%
3/26 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
20.0%
3/15 • Approximately 7 months.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term "post-treatment" refers to any assessment timepoint after the participant received at least one dose of study drug.
|
Additional Information
Eisai Medical Services
Eisai Inc.
Phone: 1-888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER