Trial Outcomes & Findings for Safety and Efficacy of Eltrombopag at Escalated Doses (NCT NCT01880047)
NCT ID: NCT01880047
Last Updated: 2019-06-11
Results Overview
To determine if patients with chronic ITP who do not respond to 75 mg of eltrombopag daily given for at least 3 weeks but then do respond to eltrombopag given daily first for 2 weeks at doses of 100, then for 2 weeks at 125 mg and finally for 4 weeks at a dose of 150mg daily. Response will be defined as 2 consecutive platelet counts of \> 50,000 with an increase of \> 20,000 from the study baseline within the 8 week increased dose window not as a result of rescue treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-06-11
Participant Flow
One splenectomized subject was removed from the study because of increased bone marrow reticulin, prior to receiving any study drug
Participant milestones
| Measure |
Non-Splenectomized Eltrombopag
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Non-Splenectomized Placebo
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
Splenectomized Eltrombopag
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Splenectomized Placebo
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
|---|---|---|---|---|
|
Weeks 0-2
STARTED
|
17
|
9
|
5
|
3
|
|
Weeks 0-2
COMPLETED
|
17
|
8
|
4
|
2
|
|
Weeks 0-2
NOT COMPLETED
|
0
|
1
|
1
|
1
|
|
Weeks 3-4
STARTED
|
17
|
8
|
4
|
2
|
|
Weeks 3-4
COMPLETED
|
17
|
7
|
4
|
2
|
|
Weeks 3-4
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Weeks 5-8
STARTED
|
17
|
7
|
4
|
2
|
|
Weeks 5-8
COMPLETED
|
15
|
6
|
4
|
2
|
|
Weeks 5-8
NOT COMPLETED
|
2
|
1
|
0
|
0
|
|
Extension Phase - 18 Months
STARTED
|
15
|
6
|
4
|
2
|
|
Extension Phase - 18 Months
COMPLETED
|
6
|
3
|
3
|
0
|
|
Extension Phase - 18 Months
NOT COMPLETED
|
9
|
3
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-splenectomized Active Drug
n=17 Participants
Includes patients on active drug who have not been splenectomized
|
Non-splenectomized Placebo
n=9 Participants
Includes patients on placebo who have not been splenectomized
|
Splectomized on Active Drug
n=5 Participants
Includes patients on active drug who have been splenectomized
|
Splectomized on Placebo
n=3 Participants
Includes patients on placebo who have been splenectomized
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=17 Participants
|
5 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
13 Participants
n=34 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=17 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
15 Participants
n=34 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=17 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=34 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=17 Participants
|
6 Participants
n=9 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
18 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=17 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
16 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
9 participants
n=9 Participants
|
5 participants
n=5 Participants
|
3 participants
n=3 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: 8 weeksTo determine if patients with chronic ITP who do not respond to 75 mg of eltrombopag daily given for at least 3 weeks but then do respond to eltrombopag given daily first for 2 weeks at doses of 100, then for 2 weeks at 125 mg and finally for 4 weeks at a dose of 150mg daily. Response will be defined as 2 consecutive platelet counts of \> 50,000 with an increase of \> 20,000 from the study baseline within the 8 week increased dose window not as a result of rescue treatment.
Outcome measures
| Measure |
Non-Splenectomized Eltrombopag
n=15 Participants
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Non-Splenectomized Placebo
n=6 Participants
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
Splenectomized Eltrombopag
n=4 Participants
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Splenectomized Placebo
n=2 Participants
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
|---|---|---|---|---|
|
Number of Patients Responding to >75mg Daily as Defined by a Rise in Platelet Count by 20,000/Microliter, With a Total Platelet Count >50,000/Microliter, ON TWO CONSECUTIVE OCCASIONS During the 8 Week Period
|
10 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 weeksMonitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
Outcome measures
| Measure |
Non-Splenectomized Eltrombopag
n=15 Participants
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Non-Splenectomized Placebo
n=6 Participants
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
Splenectomized Eltrombopag
n=4 Participants
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Splenectomized Placebo
n=2 Participants
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
|---|---|---|---|---|
|
Number of Particiapants With Drug Related Adverse Events
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Non-Splenectomized Eltrombopag
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Non-Splenectomized Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Splenectomized Eltrombopag
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Splenectomized Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Eltrombopag 100 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Eltombopag 125
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Eltombopag 150
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo 100
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo 125
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo 150
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Open Label Phase
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-Splenectomized Eltrombopag
n=17 participants at risk
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Non-Splenectomized Placebo
n=9 participants at risk
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
Splenectomized Eltrombopag
n=5 participants at risk
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Splenectomized Placebo
n=3 participants at risk
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
Eltrombopag 100 mg
n=22 participants at risk
This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 100 mg dose
|
Eltombopag 125
n=21 participants at risk
This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 125 mg dose
|
Eltombopag 150
n=19 participants at risk
This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 150 mg dose
|
Placebo 100
n=11 participants at risk
This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 100 mg dose
|
Placebo 125
n=10 participants at risk
This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 125 mg dose
|
Placebo 150
n=8 participants at risk
This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 150 mg dose
|
Open Label Phase
n=27 participants at risk
Subjects included are those who were on placebo and those who were on eltrombopag, all at 150 mg dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Increased liver enzymes >3 times ULN
|
5.9%
1/17 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/9 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/5 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
4.5%
1/22 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/21 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/19 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/11 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/10 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/8 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/27 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
|
Gastrointestinal disorders
Rectal Prolapse
|
0.00%
0/17 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
11.1%
1/9 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/5 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/22 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
4.8%
1/21 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
5.3%
1/19 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/11 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/10 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/8 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/27 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
Other adverse events
| Measure |
Non-Splenectomized Eltrombopag
n=17 participants at risk
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Non-Splenectomized Placebo
n=9 participants at risk
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
Splenectomized Eltrombopag
n=5 participants at risk
Subjects randomized to this group were treated with 100 mg daily eltrombopag for 2 weeks, then escalated to 125 mg daily for 2 weeks and then to 150 mg daily for 4 weeks
|
Splenectomized Placebo
n=3 participants at risk
Subjects randomized to this group were treated with 75 mg eltrombopag plus placebo for 8 weeks
|
Eltrombopag 100 mg
n=22 participants at risk
This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 100 mg dose
|
Eltombopag 125
n=21 participants at risk
This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 125 mg dose
|
Eltombopag 150
n=19 participants at risk
This group includes subjects on active drug (splenectomized and no-splenectomized who had adverse events at the 150 mg dose
|
Placebo 100
n=11 participants at risk
This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 100 mg dose
|
Placebo 125
n=10 participants at risk
This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 125 mg dose
|
Placebo 150
n=8 participants at risk
This group includes subjects on placebo (splenectomized and no-splenectomized who had adverse events at the 150 mg dose
|
Open Label Phase
n=27 participants at risk
Subjects included are those who were on placebo and those who were on eltrombopag, all at 150 mg dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Transaminitis
|
11.8%
2/17 • Number of events 2 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
11.1%
1/9 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
20.0%
1/5 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
33.3%
1/3 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/22 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
9.5%
2/21 • Number of events 3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
15.8%
3/19 • Number of events 3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/11 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
10.0%
1/10 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
12.5%
1/8 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
7.4%
2/27 • Number of events 3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
|
Blood and lymphatic system disorders
Bleeding
|
11.8%
2/17 • Number of events 3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
22.2%
2/9 • Number of events 2 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
20.0%
1/5 • Number of events 2 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
13.6%
3/22 • Number of events 5 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
9.5%
2/21 • Number of events 3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
31.6%
6/19 • Number of events 8 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
18.2%
2/11 • Number of events 4 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
30.0%
3/10 • Number of events 3 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
50.0%
4/8 • Number of events 6 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
59.3%
16/27 • Number of events 22 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
|
Infections and infestations
Respiratory infection
|
58.8%
10/17 • Number of events 15 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
44.4%
4/9 • Number of events 7 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
20.0%
1/5 • Number of events 2 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
33.3%
1/3 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
4.5%
1/22 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
4.8%
1/21 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
15.8%
3/19 • Number of events 4 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
0.00%
0/11 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
10.0%
1/10 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
12.5%
1/8 • Number of events 1 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
14.8%
4/27 • Number of events 4 • Data were collected over the 8 week primary study period
Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place