Trial Outcomes & Findings for Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia (NCT NCT04571645)
NCT ID: NCT04571645
Last Updated: 2024-04-15
Results Overview
Overall survival was defined for all study participants through 5 years after randomization. Overall survival was to be measured from the date of randomization to the date of death from any cause. Participants not known to have died at last follow-up contact were to be censored on the date they were last known to be alive. Due to early termination, subjects did not complete long term follow-up and efficacy (including overall survival outcome) was not analyzed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
Measured from randomization to date of death from any cause, up to 1 year.
Results posted on
2024-04-15
Participant Flow
Participant milestones
| Measure |
Dociparstat Sodium (DSTAT)
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Dociparstat 4 mg/kg IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.
Dociparstat sodium: Dociparstat is a glycosaminoglycan derived from porcine heparin.
|
Control
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Placebo IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Placebo via continuous IV infusion 24 hours daily for 5 or 7 days.
Placebo: 0.9% Normal Saline
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Dociparstat Sodium (DSTAT)
n=5 Participants
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Dociparstat 4 mg/kg IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.
Dociparstat sodium: Dociparstat is a glycosaminoglycan derived from porcine heparin.
|
Control
n=4 Participants
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Placebo IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Placebo via continuous IV infusion 24 hours daily for 5 or 7 days.
Placebo: 0.9% Normal Saline
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=99 Participants
|
64 years
n=107 Participants
|
65 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Measured from randomization to date of death from any cause, up to 1 year.Population: Due to the early termination of the study, efficacy (overall survival) was not formally analyzed.
Overall survival was defined for all study participants through 5 years after randomization. Overall survival was to be measured from the date of randomization to the date of death from any cause. Participants not known to have died at last follow-up contact were to be censored on the date they were last known to be alive. Due to early termination, subjects did not complete long term follow-up and efficacy (including overall survival outcome) was not analyzed.
Outcome measures
| Measure |
Dociparstat Sodium (DSTAT)
n=5 Participants
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Dociparstat 4 mg/kg IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.
Dociparstat sodium: Dociparstat is a glycosaminoglycan derived from porcine heparin.
|
Control
n=4 Participants
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Placebo IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Placebo via continuous IV infusion 24 hours daily for 5 or 7 days.
Placebo: 0.9% Normal Saline
|
|---|---|---|
|
Overall Survival
|
4 Participants
|
4 Participants
|
Adverse Events
Dociparstat Sodium (DSTAT)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Control
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dociparstat Sodium (DSTAT)
n=5 participants at risk
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Dociparstat 4 mg/kg IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.
Dociparstat sodium: Dociparstat is a glycosaminoglycan derived from porcine heparin.
|
Control
n=4 participants at risk
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Placebo IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Placebo via continuous IV infusion 24 hours daily for 5 or 7 days.
Placebo: 0.9% Normal Saline
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
General disorders
Pyrexia
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
Other adverse events
| Measure |
Dociparstat Sodium (DSTAT)
n=5 participants at risk
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Dociparstat 4 mg/kg IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.
Dociparstat sodium: Dociparstat is a glycosaminoglycan derived from porcine heparin.
|
Control
n=4 participants at risk
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Placebo IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Placebo via continuous IV infusion 24 hours daily for 5 or 7 days.
Placebo: 0.9% Normal Saline
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
3/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
60.0%
3/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
50.0%
2/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Cardiac disorders
Cardiac failure
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Cardiac disorders
Diastolic dysfunction
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Cardiac disorders
Ventricular tachycardia
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Eye disorders
Eye pain
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Eye disorders
Periorbital oedema
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Constipation
|
80.0%
4/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Dental caries
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
5/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
75.0%
3/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Dyspepsia
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
50.0%
2/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Haemorrhoids
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Melaena
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Oral pain
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Stomatitis
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Toothache
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
General disorders
Catheter site rash
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
General disorders
Chills
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
General disorders
Fatigue
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
General disorders
Mucosal inflammation
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
General disorders
Oedema peripheral
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
50.0%
2/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
General disorders
Pyrexia
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
50.0%
2/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Adenovirus infection
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Bacteraemia
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Enterocolitis infectious
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Pneumonia
|
80.0%
4/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Pneumonia bacterial
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Rhinovirus infection
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Infections and infestations
Skin infection
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Investigations
Blood albumin decreased
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Investigations
Brain natriuretic peptide increased
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Investigations
International normalised ratio increased
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
50.0%
2/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Investigations
White blood cell count decreased
|
80.0%
4/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Fluid overload
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
60.0%
3/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
50.0%
2/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Psychiatric disorders
Hallucination
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Renal and urinary disorders
Bladder spasm
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
50.0%
2/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
40.0%
2/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
25.0%
1/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
|
Vascular disorders
Orthostatic hypotension
|
20.0%
1/5 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
0.00%
0/4 • All-cause mortality was assessed through study completion, up to 1 year; all adverse events were collected through 42 days after the start of the last cycle of study intervention, up to 168 days.
Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within 18 months of the completion of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given opportunity to review and comment. Institution publications may be delayed up to an additional 60 days to allow Sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER