Trial Outcomes & Findings for Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501 (NCT NCT01355289)
NCT ID: NCT01355289
Last Updated: 2018-02-22
Results Overview
A responder was defined as a participant having a platelet count of greater than or equal to 100x10\^9/L by Day 21 starting from an average baseline platelet count of greater than 20 x 10\^9/L to less than or equal to 70 x 10\^9/L.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Baseline to Day 21
Results posted on
2018-02-22
Participant Flow
The Screening Period encompassed 14 days ±7 days. Prerandomization assessments took place in all participants who had provided informed consent.
Participant milestones
| Measure |
Placebo (Core Study)
Placebo, was given orally for up to 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 30 mg (Core Study)
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag (Open Label Extension)
Avatrombopag was initiated at a dose of 20 mg, once daily in the open label extension (OLE) period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
|
|---|---|---|---|---|---|
|
Core Study
STARTED
|
17
|
16
|
18
|
14
|
0
|
|
Core Study
COMPLETED
|
16
|
16
|
18
|
12
|
0
|
|
Core Study
NOT COMPLETED
|
1
|
0
|
0
|
2
|
0
|
|
Open Label Extension
STARTED
|
0
|
0
|
0
|
0
|
62
|
|
Open Label Extension
COMPLETED
|
0
|
0
|
0
|
0
|
28
|
|
Open Label Extension
NOT COMPLETED
|
0
|
0
|
0
|
0
|
34
|
Reasons for withdrawal
| Measure |
Placebo (Core Study)
Placebo, was given orally for up to 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 30 mg (Core Study)
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag (Open Label Extension)
Avatrombopag was initiated at a dose of 20 mg, once daily in the open label extension (OLE) period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
|
|---|---|---|---|---|---|
|
Core Study
Adverse Event, Non-Fatal
|
1
|
0
|
0
|
0
|
0
|
|
Core Study
Inadequate Therapeutic Effect
|
0
|
0
|
0
|
1
|
0
|
|
Core Study
Other
|
0
|
0
|
0
|
1
|
0
|
|
Open Label Extension
Adverse Event, Non-Fatal
|
0
|
0
|
0
|
0
|
1
|
|
Open Label Extension
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Open Label Extension
Inadequate Therapeutic Effect
|
0
|
0
|
0
|
0
|
29
|
|
Open Label Extension
Other
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501
Baseline characteristics by cohort
| Measure |
Placebo (Core Study)
n=17 Participants
Placebo, was given orally for upto 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
n=16 Participants
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
n=18 Participants
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 30 mg (Core Study)
n=14 Participants
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.2 Years
STANDARD_DEVIATION 7.96 • n=93 Participants
|
55.3 Years
STANDARD_DEVIATION 8.06 • n=4 Participants
|
54.9 Years
STANDARD_DEVIATION 7.38 • n=27 Participants
|
53.6 Years
STANDARD_DEVIATION 7.26 • n=483 Participants
|
53.5 Years
STANDARD_DEVIATION 7.78 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
48 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 21Population: Full analysis set (FAS), the group of all randomized participants of core study.
A responder was defined as a participant having a platelet count of greater than or equal to 100x10\^9/L by Day 21 starting from an average baseline platelet count of greater than 20 x 10\^9/L to less than or equal to 70 x 10\^9/L.
Outcome measures
| Measure |
Placebo (Core Study)
n=17 Participants
Placebo, was given orally for up to 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
n=16 Participants
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
n=18 Participants
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days
|
Avatrombopag 30 mg (Core Study)
n=14 Participants
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core Study
Yes
|
1 Participants
|
6 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core Study
No
|
16 Participants
|
10 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 7 and Day 14Population: Full analysis set (FAS), the group of all randomized participants of core study.
Missing platelet counts were imputed using last observation carried forward (LOCF) approach for subjects who achieved platelet response at prior visits.
Outcome measures
| Measure |
Placebo (Core Study)
n=17 Participants
Placebo, was given orally for up to 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
n=16 Participants
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
n=18 Participants
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days
|
Avatrombopag 30 mg (Core Study)
n=14 Participants
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days
|
|---|---|---|---|---|
|
Change From Baseline of Local Platelet Count by Visit During Treatment Period A1 of Core Study
Day 7
|
-0.1 cells x 10^9/L
Standard Deviation 7.15
|
19.8 cells x 10^9/L
Standard Deviation 17.59
|
26.5 cells x 10^9/L
Standard Deviation 22.06
|
30.9 cells x 10^9/L
Standard Deviation 37.65
|
|
Change From Baseline of Local Platelet Count by Visit During Treatment Period A1 of Core Study
Day 14
|
-0.2 cells x 10^9/L
Standard Deviation 13.79
|
29.2 cells x 10^9/L
Standard Deviation 18.32
|
57.2 cells x 10^9/L
Standard Deviation 31.39
|
55.4 cells x 10^9/L
Standard Deviation 37.47
|
SECONDARY outcome
Timeframe: Baseline to Day 21Population: Full analysis set (FAS), the group of all randomized participants of core study.
Blood draws were taken to monitor platelet counts.
Outcome measures
| Measure |
Placebo (Core Study)
n=17 Participants
Placebo, was given orally for up to 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
n=16 Participants
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
n=18 Participants
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days
|
Avatrombopag 30 mg (Core Study)
n=14 Participants
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Platelet Count Greater Than 30 X 10^9/L From Baseline to Day 21 During Treatment Period A1 of Core Study
No
|
16 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Who Achieved Platelet Count Greater Than 30 X 10^9/L From Baseline to Day 21 During Treatment Period A1 of Core Study
Yes
|
1 Participants
|
9 Participants
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 21Population: Full analysis set (FAS), the group of all randomized participants of core study.
Blood draws were taken to monitor platelet counts during the first 21 days of study treatment. When a platelet count of greater than or equal to 100 X 10\^9/L was attained, antiviral treatment was initiated.
Outcome measures
| Measure |
Placebo (Core Study)
n=17 Participants
Placebo, was given orally for up to 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
n=16 Participants
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
n=18 Participants
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days
|
Avatrombopag 30 mg (Core Study)
n=14 Participants
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days
|
|---|---|---|---|---|
|
Number of Participants Who Initiated Antiviral Treatment by Day 21 of Period A1 of Core Study
No
|
16 Participants
|
10 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Who Initiated Antiviral Treatment by Day 21 of Period A1 of Core Study
Yes
|
1 Participants
|
6 Participants
|
13 Participants
|
9 Participants
|
Adverse Events
Placebo (Core Study)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Avatrombopag 10 mg (Core Study)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Avatrombopag 20 mg (Core Study)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Avatrombopag 30 mg (Core Study)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Avatrombopag (Open Label Extension)
Serious events: 13 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Core Study)
n=17 participants at risk
Placebo, was given orally for up to 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
n=16 participants at risk
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
n=18 participants at risk
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 30 mg (Core Study)
n=14 participants at risk
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag (Open Label Extension)
n=64 participants at risk
Avatrombopag was initiated at a dose of 20 mg, once daily in the open label extension (OLE) period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
3.1%
2/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
3.1%
2/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
3.1%
2/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
1.6%
1/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
Other adverse events
| Measure |
Placebo (Core Study)
n=17 participants at risk
Placebo, was given orally for up to 21 days once daily.
|
Avatrombopag 10 mg (Core Study)
n=16 participants at risk
Avatrombopag 10 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 20 mg (Core Study)
n=18 participants at risk
Avatrombopag 20 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag 30 mg (Core Study)
n=14 participants at risk
Avatrombopag 30 mg, was administered orally, once daily, preferably with food for up to 21 days.
|
Avatrombopag (Open Label Extension)
n=64 participants at risk
Avatrombopag was initiated at a dose of 20 mg, once daily in the open label extension (OLE) period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
12.5%
2/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
11.1%
2/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
32.8%
21/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
16.7%
3/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
21.9%
14/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.8%
5/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
12.5%
2/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
22.2%
4/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.3%
2/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
31.2%
20/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
9.4%
6/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Abdominal Pain upper
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.8%
5/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
9.4%
6/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
11.1%
2/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.3%
2/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
17.2%
11/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
12.5%
2/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
4/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
4/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
18.8%
3/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
22.2%
4/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.3%
2/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
31.2%
20/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
12.5%
8/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Asthenia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
11.1%
2/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
12.5%
8/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Chills
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
18.8%
3/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
16.7%
3/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
20.3%
13/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Fatigue
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
16.7%
3/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.3%
2/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
25.0%
16/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Influenza like illness
|
11.8%
2/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
22.2%
4/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
21.4%
3/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
17.2%
11/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Injection site erythema
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
9.4%
6/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Irritability
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
10.9%
7/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
9.4%
6/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
11.1%
2/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.3%
2/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.1%
9/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
4/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
12.5%
2/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
4/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
4/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
4/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
16.7%
3/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.3%
2/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
18.8%
12/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.8%
5/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
21.4%
3/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
20.3%
13/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
11.1%
2/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
21.4%
3/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.1%
9/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
11.1%
2/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
4/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
4/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.3%
2/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
9.4%
6/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
25.0%
4/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
14.3%
2/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
23.4%
15/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
2/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
11.1%
2/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
18.8%
12/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Congenital, familial and genetic disorders
Congenital lymphoedema
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
11.1%
2/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Chest discomfort
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Feeling cold
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Injection site pruritus
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
General disorders
Pain
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Hepatobiliary disorders
Liver tenderness
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Investigations
Weight decreased
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Psychiatric disorders
Food aversion
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
7.1%
1/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Vascular disorders
Pallor
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
5.6%
1/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/17 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
6.2%
1/16 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/18 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/14 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
0.00%
0/64 • For each participant, treatment emergent adverse events were collected from the first day of administration of study drug up to 30 days after the last dose of study drug or up to approximately 2.5 years.
Core Study Safety Analysis Set (SAS): All participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. OLE Safety Analysis Set: All participants who received at least 1 dose of avatrombopag study drug (either in the Core Study or the Extension Phase) and had a postdose safety assessment.
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER