Trial Outcomes & Findings for PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer (NCT NCT04404361)

Last Updated: 2024-06-05

Results Overview

The percentage is calculated as the number of patients who progress to IMV/ECMO or death divided by the total number of patients in the ITT population (n/N \* 100).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

Baseline to Day 28

Results posted on

2024-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Pacritinib and SOC Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
Overall Study STARTED	99	101
Overall Study COMPLETED	68	80
Overall Study NOT COMPLETED	31	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Pacritinib and SOC Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
Overall Study Death	12	12
Overall Study Withdrawal by Subject	13	5
Overall Study Lost to Follow-up	6	3
Overall Study patient hospitalized and was nonverbal at the end of the study	0	1

Baseline Characteristics

PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pacritinib and SOC n=99 Participants Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 Participants 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules	Total n=200 Participants Total of all reporting groups
Age, Continuous	60.0 years n=5 Participants	59.0 years n=7 Participants	60.0 years n=5 Participants
Age, Customized Age group · <60 years	48 Participants n=5 Participants	51 Participants n=7 Participants	99 Participants n=5 Participants
Age, Customized Age group · ≥60 years	51 Participants n=5 Participants	50 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	37 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	64 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants	81 Participants n=7 Participants	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	99 participants n=5 Participants	101 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28

The percentage is calculated as the number of patients who progress to IMV/ECMO or death divided by the total number of patients in the ITT population (n/N \* 100).

Outcome measures

Outcome measures
Measure	Pacritinib and SOC n=99 Participants Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 Participants 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
Percentage of Participants With Progression to IMV and/or ECMO or Death	26 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline to Day 28

the number of days that patients are alive and not intubated, from randomization to Day 28

Outcome measures

Outcome measures
Measure	Pacritinib and SOC n=99 Participants Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 Participants 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
The Number of Ventilator-Free Days	22.1 days Standard Deviation 10.2	22.6 days Standard Deviation 9.35

SECONDARY outcome

Timeframe: Baseline to Day 28

the number of patients with outcome of death during the 28 days following randomization

Outcome measures

Outcome measures
Measure	Pacritinib and SOC n=99 Participants Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 Participants 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
The Mortality Rate at Day 28	10.1 % of patients with outcome of death /D28 Interval 5.0 to 17.8	7.9 % of patients with outcome of death /D28 Interval 3.5 to 15.0

SECONDARY outcome

Timeframe: Baseline to Day 15

the number of patients with outcome of death in the 15 days following randomization

Outcome measures

Outcome measures
Measure	Pacritinib and SOC n=99 Participants Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 Participants 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
The Mortality Rate at Day 15	5.1 % of patients with outcome of death /D15 Interval 1.7 to 11.4	4.0 % of patients with outcome of death /D15 Interval 1.1 to 9.8

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22, and 28.

Time to Improvement (days) = Date of improvement - Date of randomization + 1. Date of Improvement was defined as the time to first ordinal scale assessment 2 points or more lower than the baseline clinical status assessment.

Outcome measures

Outcome measures
Measure	Pacritinib and SOC n=99 Participants Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 Participants 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status	9.0 days Interval 8.0 to 10.0	9.0 days Interval 7.0 to 11.0

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22, 28

Clinical status assessment based on the adapted scale from Cao et al. The patient CS is summarized by study visit. STATUS: 1. not hospitalized with resumption of normal activities; 2. not hospitalized but unable to resume normal activities; 3. hospitalization, not requiring supplemental oxygen; 4. hospitalization, requiring supplemental oxygen not meeting the criteria for categories 5 or 6; 5. hospitalization, on non-invasive positive pressure ventilation or high-flow nasal cannula; 6. hospitalization, requiring IMV and/or ECMO; 7. death.

Outcome measures

Outcome measures
Measure	Pacritinib and SOC n=99 Participants Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 Participants 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 28: Clinical status 2	32 participants	42 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 8 : Clinical status 1	15 participants	11 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 8 : Clinical status 2	23 participants	37 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 8 : Clinical status 3	5 participants	3 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 8 : Clinical status 4	20 participants	11 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 8 : Clinical status 5	15 participants	20 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 8 : Clinical status 6	9 participants	14 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 8 : Clinical status 7	0 participants	1 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 8 : Clinical status Missing	12 participants	4 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 15: Clinical status 1	19 participants	17 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 15: Clinical status 2	43 participants	47 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 15: Clinical status 3	1 participants	1 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 15: Clinical status 4	2 participants	8 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 15: Clinical status 5	5 participants	2 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 15: Clinical status 6	10 participants	16 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 15: Clinical status 7	0 participants	2 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 15: Clinical status Missing	19 participants	8 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 22: Clinical status 1	27 participants	24 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 22: Clinical status 2	36 participants	48 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 22: Clinical status 3	1 participants	0 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 22: Clinical status 4	0 participants	1 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 22: Clinical status 5	4 participants	1 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 22: Clinical status 6	7 participants	12 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 22: Clinical status 7	3 participants	1 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 22: Clinical status Missing	21 participants	14 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 28: Clinical status 1	31 participants	30 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 28: Clinical status 3	0 participants	0 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 28: Clinical status 4	3 participants	2 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 28: Clinical status 5	2 participants	1 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 28: Clinical status 6	6 participants	10 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 28: Clinical status 7	0 participants	1 participants
The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 Day 28: Clinical status Missing	25 participants	15 participants

SECONDARY outcome

Timeframe: Baseline to Day 28

the proportion of patients reporting use of medications such as corticosteroids, tocilizumab, anakinra, or eculizumab as treatment for COVID-19, during 28 days following randomization

Outcome measures

Outcome measures
Measure	Pacritinib and SOC n=99 Participants Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 Participants 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19	97 Participants	96 Participants

Adverse Events

Pacritinib and SOC

Serious events: 20 serious events

Other events: 74 other events

Deaths: 12 deaths

Placebo and SOC

Serious events: 33 serious events

Other events: 79 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Pacritinib and SOC n=96 participants at risk Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC Pacritinib: 100 mg capsules	Placebo and SOC n=101 participants at risk 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC Placebo: Placebo capsules matching pacritinib 100 mg capsules
Respiratory, thoracic and mediastinal disorders respiratory failure	7.3% 7/96 • Number of events 7 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	14.9% 15/101 • Number of events 15 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Respiratory, thoracic and mediastinal disorders acute respiratory failure	6.2% 6/96 • Number of events 6 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	7.9% 8/101 • Number of events 8 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Respiratory, thoracic and mediastinal disorders hypoxia	4.2% 4/96 • Number of events 5 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	5.9% 6/101 • Number of events 8 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Infections and infestations septic shock	2.1% 2/96 • Number of events 2 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	5.9% 6/101 • Number of events 6 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Renal and urinary disorders acute kidney injury	3.1% 3/96 • Number of events 3 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	3.0% 3/101 • Number of events 3 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Cardiac disorders cardiac arrest	1.0% 1/96 • Number of events 1 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	3.0% 3/101 • Number of events 3 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Respiratory, thoracic and mediastinal disorders acute respiratory distress syndrome	3.1% 3/96 • Number of events 3 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	0.00% 0/101 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Cardiac disorders hypotension	2.1% 2/96 • Number of events 2 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	0.99% 1/101 • Number of events 1 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/96 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	3.0% 3/101 • Number of events 3 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).
Cardiac disorders cardio-respiratory arrest	2.1% 2/96 • Number of events 2 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).	0.00% 0/101 • Daily (Days 2 through 28), End of Treatment (for inpatients only), Day of hospital discharge, Weekly outpatient assessment (to evaluate daily AEs), 30-day Post End of Treatment. AE data were collected from the time of randomization through 30 days following the last dose of pacritinib/placebo. regular investigator assessment 3 patients randomized to PAC but received the Placebo + SOC, the randomized treatment did not match with the actual treatment received. Because this is a safety summary the Safety population summarizes the information according to the actual treatment received and not the treatment that was assigned (randomized).

Other adverse events

Additional Information

John Volpone

CTI BioPharma Corp.

Phone: 206-351-7663

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place