Trial Outcomes & Findings for Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia (NCT NCT02873338)
NCT ID: NCT02873338
Last Updated: 2023-09-07
Results Overview
Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) \>1000/microliter; platelet count \>100,000, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)
Results posted on
2023-09-07
Participant Flow
Note that 2 randomized subjects did not receive study treatment: 1 subject in the control group and 1 subject in the dociparstat 0.25 mg/kg group. Therefore, these 2 subjects are not included in the safety analysis, but are included in the efficacy analyses.
Participant milestones
| Measure |
Control (Idarubicin+Cytarabine)
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, 3)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)
Reinduction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1, 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1-5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)
|
Dociparstat 0.125 mg/kg
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)
Reinduction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion on (Days 1-5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hrs, every 12 hrs (Days 1, 3, 5)
|
Dociparstat 0.25 mg/kg
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)
Reinduction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
24
|
|
Overall Study
COMPLETED
|
8
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
18
|
21
|
18
|
Reasons for withdrawal
| Measure |
Control (Idarubicin+Cytarabine)
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, 3)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)
Reinduction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1, 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1-5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)
|
Dociparstat 0.125 mg/kg
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)
Reinduction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion (Days 1-5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hr IV infusion on (Days 1-5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hrs, every 12 hrs (Days 1, 3, 5)
|
Dociparstat 0.25 mg/kg
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, 3)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-7)
Reinduction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2)
* Cytarabine 100 mg/m2/day continuous 24-hr IV infusion (Days 1-5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/h continuous 24-hr IV infusion (Days 1-5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
|
Overall Study
Death
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
0
|
|
Overall Study
Other or Missing
|
14
|
15
|
13
|
Baseline Characteristics
Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 3.6 • n=99 Participants
|
67 years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
68 years
STANDARD_DEVIATION 4.3 • n=206 Participants
|
67 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Acute myeloid leukemia (AML) subtype
De novo
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Acute myeloid leukemia (AML) subtype
Secondary
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Time since acute myeloid leukemia (AML) diagnosis
|
1.1 weeks
STANDARD_DEVIATION 1.19 • n=99 Participants
|
1.2 weeks
STANDARD_DEVIATION 1.15 • n=107 Participants
|
1.0 weeks
STANDARD_DEVIATION 0.75 • n=206 Participants
|
1.1 weeks
STANDARD_DEVIATION 1.04 • n=7 Participants
|
|
Baseline blasts in bone marrow
|
44 percentage
STANDARD_DEVIATION 25.9 • n=99 Participants
|
47 percentage
STANDARD_DEVIATION 22.3 • n=107 Participants
|
46 percentage
STANDARD_DEVIATION 26.6 • n=206 Participants
|
46 percentage
STANDARD_DEVIATION 24.6 • n=7 Participants
|
PRIMARY outcome
Timeframe: During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) \>1000/microliter; platelet count \>100,000, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Number of Subjects Who Achieved Morphologic Complete Remission
|
14 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Randomization up to 30 monthsPopulation: Note: In the Dociparstat 0.125 mg/kg group, fewer than half of the subjects achieved complete CR, and thus were assessed as having an event on Day 1.
Event-free survival was measured as date of randomization until treatment failure. Treatment failure was defined as failure to achieve composite completed morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response, or death from any cause, whichever occurred first.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Duration of Event-free Survival
|
243.5 days
Interval 1.0 to 853.0
|
1 days
Interval 1.0 to 922.0
|
171.5 days
Interval 1.0 to 842.0
|
SECONDARY outcome
Timeframe: Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 monthsPopulation: This analysis only included subjects who achieved composite complete remission. The following number of subjects were censored in each treatment group: * Control: 6/16 (37.5%) subjects * Dociparstat 0.125 mg/kg: 4/9 (44.4%) subjects * Dociparstat 0.25 mg/kg: 10/15 (66.7%) subjects
Leukemia-free survival was assessed as a secondary endpoint only in subjects who achieved composite complete remission and was measured from randomization until disease relapse or death from any cause, whichever occurred first. Assessments were performed every 3 months until death or 18 months after the last subject was randomized, whichever occurred first.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=16 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=9 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=15 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Time to Leukemia-free Survival
|
292 days
Interval 1.0 to 581.0
|
448 days
Interval 26.0 to 494.0
|
166 days
Interval 1.0 to 315.0
|
SECONDARY outcome
Timeframe: Randomization to end of study (18 months)Overall survival was measured from the date of randomization until death from any cause. Assessments were performed every 3 months and continued until death or 18 months after the last patient was randomized, whichever came first.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Number of Subjects Who Achieved Overall Survival
Subjects died
|
14 Participants
|
14 Participants
|
9 Participants
|
|
Number of Subjects Who Achieved Overall Survival
Subjects still alive
|
12 Participants
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 60 days after the start of each treatment cycleThe composite complete remission (CR) rate included CR, CR without recovery of platelets (CRp), and CR without recovery of neutrophils and/or platelets (CRi), as defined by the International Working Group criteria during the induction and re-induction phases of treatment. CR was defined as an Absolute Neutrophil Count (ANC) \>1000/μL, platelet count \>100,000/μL, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. CRi was defined as an ANC \<1000/μL and/or platelet count \<100,000/, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Number of Subjects Who Achieved Composite Complete Remission
|
16 Participants
|
9 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Randomization to end of study (18 months)Population: This analysis only included subjects who had achieved morphologic complete remission. The following number of subjects were censored in each treatment group for this analysis; however the full ranges include censored subjects: * Control: 7/14 (50%) subjects * Dociparstat 0.125 mg/kg: 6/8 (75.0%) subjects * Dociparstat 0.25 mg/kg: 9/11 (81.8%) subjects
The duration of morphologic complete remission was assessed only in subjects who had achieved morphologic complete remission and was defined as the time from achievement of complete response to the detection or relapse. Relapse was defined as the reappearance of leukemia blasts in the peripheral blood, \>5% blasts in the bone marrow not attributable to another cause, or appearance/reappearance of extramedullary disease and with a bone marrow blast percentage of \>5% but ≤20%. If the latter, a repeat bone marrow examination was performed at least 7 days after the first marrow examination; documentation of the bone marrow blast percentage of \>5% was necessary to establish relapse. Assessments were performed every 3 months and continued until death or 18 months after the last subject was randomized, whichever occurred first. Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse)
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=14 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=8 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=11 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Duration of Morphologic Complete Remission
|
233 days
Interval 1.0 to 451.0
|
494 days
Interval 1.0 to 494.0
|
294 days
Interval 1.0 to 315.0
|
SECONDARY outcome
Timeframe: Randomization to ANC recovery, for up to 60 days after the start of each treatment cyclePopulation: The following number of subjects were censored in each treatment group for both analyses (neutrophil recovery to \>500/µL and \>1000/µL): * Control: 6/26 (23.1%) subjects for both analyses (\>500/µL and \>1000/µL) * Dociparstat 0.125 mg/kg: 9/25 (36.0%) subjects for both analyses (\>500/µL and \>1000/µL) * Dociparstat 0.25 mg/kg: 7/24 (29.2%) subjects for \>500/µL and 11/24 (45.8%) subjects for \>1000/µL
Neutrophil recovery was assessed from randomization to Absolute Neutrophil Count (ANC) recovery (ANC \>500/µL and \>1000/µL) for up to 60 days after the start of each treatment cycle.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Time to Recovery of Neutrophils
Recovery to >500/µL
|
32 days
Interval 1.0 to 57.0
|
43 days
Interval 9.0 to 70.0
|
29 days
Interval 1.0 to 51.0
|
|
Time to Recovery of Neutrophils
Recovery to >1000/µL
|
37 days
Interval 1.0 to 64.0
|
42 days
Interval 9.0 to 70.0
|
35 days
Interval 1.0 to 57.0
|
SECONDARY outcome
Timeframe: Randomization to platelet recovery, for up to 60 days after the start of each treatment cyclePopulation: The following number of subjects were censored in each treatment group for each analysis (platelet recovery to \>20,000µL and \>100,000µL): * Control: 5/26 (19.2%) subjects for \>20,000µL and 7/26 (26.9%) subjects for \>100,000µL * Dociparstat 0.125 mg/kg: 5/25 (20%) subjects for \>20,000µL and 12/25 (48.0%) subjects for \>100,000µL * Dociparstat 0.25 mg/kg: 8/24 (33.3%) subjects for \>20,000µL and 11/24 (45.8%) subjects for \>100,000µL
Platelet recovery was measured from randomization to platelet recovery (platelet count \>20,000/µL and \>100,000/µL)
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Time to Platelet Recovery
Recovery to >20,000µL
|
35 days
Interval 1.0 to 71.0
|
36 days
Interval 16.0 to 70.0
|
29 days
Interval 1.0 to 56.0
|
|
Time to Platelet Recovery
Recovery to >100,000µL
|
38 days
Interval 1.0 to 71.0
|
50 days
Interval 16.0 to 70.0
|
32 days
Interval 1.0 to 56.0
|
SECONDARY outcome
Timeframe: 30 days (from first day of induction treatment to 30 days after)Mortality (rate of death) of subjects by Day 30, measured from the first day of induction treatment to 30 days post-induction.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Number of Subjects Who Died by Day 30
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 60 days (from the first day of induction treatment to 60 days after)Mortality (rate of death) of subjects by Day 60, measured from the first day of induction treatment to 60 days post-induction.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Number of Subjects Who Died by Day 60.
|
2 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 90 days (from the first day of induction treatment to 90 days after)Mortality (rate of death) of subjects at Day 90, measured from the first day of induction treatment to 90 days post-induction.
Outcome measures
| Measure |
Control (Idarubicin+Cytarabine)
n=26 Participants
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/h continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=24 Participants
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Number of Subjects Who Died by Day 90
|
2 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Control (Idarubicin+Cytarabine)
Serious events: 7 serious events
Other events: 25 other events
Deaths: 14 deaths
Dociparstat 0.125 mg/kg
Serious events: 8 serious events
Other events: 25 other events
Deaths: 14 deaths
Dociparstat 0.25 mg/kg
Serious events: 13 serious events
Other events: 23 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Control (Idarubicin+Cytarabine)
n=25 participants at risk
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 participants at risk
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=23 participants at risk
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hr IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Pyrexia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Pneumonia fungal
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Urosepsis
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
Other adverse events
| Measure |
Control (Idarubicin+Cytarabine)
n=25 participants at risk
Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.125 mg/kg
n=25 participants at risk
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
Dociparstat 0.25 mg/kg
n=23 participants at risk
Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hr IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
|
|---|---|---|---|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.0%
9/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
34.8%
8/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.0%
8/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
21.7%
5/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
36.0%
9/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
17.4%
4/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
28.0%
7/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Vascular disorders
Hypertension
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
26.1%
6/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Vascular disorders
Hypotension
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Vascular disorders
Thrombophlebitis superficial
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
56.0%
14/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
64.0%
16/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
73.9%
17/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
52.0%
13/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
48.0%
12/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
34.8%
8/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
17.4%
4/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.0%
7/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Cardiac disorders
Tachycardia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Cardiac disorders
Atrial flutter
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Eye disorders
Vision blurred
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Eye disorders
Eye irritation
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Eye disorders
Eye pain
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
64.0%
16/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
60.0%
15/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
65.2%
15/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
56.0%
14/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
56.0%
14/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
65.2%
15/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
10/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
28.0%
7/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
39.1%
9/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
32.0%
8/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
39.1%
9/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
34.8%
8/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
21.7%
5/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
30.4%
7/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Chapped lips
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Haematochezia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Ileus
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Oedema peripheral
|
56.0%
14/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
64.0%
16/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
52.2%
12/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Pyrexia
|
52.0%
13/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
32.0%
8/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
39.1%
9/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Fatigue
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
44.0%
11/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
43.5%
10/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Chills
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
17.4%
4/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Mucosal inflammation
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
17.4%
4/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Peripheral swelling
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Localised oedema
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Oedema
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Injection site bruising
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Pneumonia
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Sepsis
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Clostridium difficile colitis
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Bacteraemia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Candida infection
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Enterococcal infection
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Pneumonia fungal
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Platelet count decreased
|
32.0%
8/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
36.0%
9/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
30.4%
7/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
White blood cell count decreased
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
28.0%
7/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
30.4%
7/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
21.7%
5/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Neutrophil count decreased
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
30.4%
7/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
17.4%
4/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
26.1%
6/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Blood bilirubin increased
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Blood creatinine increased
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
Weight decreased
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Investigations
International normalised ration increased
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
60.0%
15/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
64.0%
16/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
56.5%
13/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.0%
7/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
40.0%
10/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
39.1%
9/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
36.0%
9/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
32.0%
8/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
39.1%
9/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
30.4%
7/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
21.7%
5/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
26.1%
6/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
28.0%
7/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Alkalosis
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Malnutrition
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Nervous system disorders
Headache
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
36.0%
9/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
26.1%
6/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Nervous system disorders
Dizziness
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
20.0%
5/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
17.4%
4/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Nervous system disorders
Dysgeusia
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Nervous system disorders
Encephalopathy
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Nervous system disorders
Syncope
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Psychiatric disorders
Insomnia
|
32.0%
8/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
24.0%
6/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
26.1%
6/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Psychiatric disorders
Anxiety
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
13.0%
3/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
21.7%
5/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Psychiatric disorders
Hallucination
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Psychiatric disorders
Delirium
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.3%
1/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Psychiatric disorders
Agitation
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
0.00%
0/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Renal and urinary disorders
Pollakiuria
|
16.0%
4/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
17.4%
4/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
1/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Renal and urinary disorders
Haematuria
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.0%
2/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
12.0%
3/25 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
8.7%
2/23 • From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Details of the Study and its results shall not be publicized or published in any form without prior consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER