Trial Outcomes & Findings for The Intravascular Cooling in the Treatment of Stroke 2/3 Trial (NCT NCT01123161)

NCT ID: NCT01123161

Last Updated: 2017-04-05

Results Overview

Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2017-04-05

Participant Flow

Participant milestones

Measure	Group1: IV t-PA and Normothermia IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
Overall Study STARTED	57	63
Overall Study COMPLETED	55	63
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Group1: IV t-PA and Normothermia IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

The Intravascular Cooling in the Treatment of Stroke 2/3 Trial

Baseline characteristics by cohort

Measure	Group1: IV t-PA and Normothermia n=57 Participants IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=63 Participants IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming	Total n=120 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 11.1 • n=5 Participants	65.5 years STANDARD_DEVIATION 10.3 • n=7 Participants	66.4 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Baseline NIHSS	14.5 points STANDARD_DEVIATION 4.9 • n=5 Participants	14.1 points STANDARD_DEVIATION 4.8 • n=7 Participants	14.3 points STANDARD_DEVIATION 4.8 • n=5 Participants
Baseline temperature	36.4 degrees (C) STANDARD_DEVIATION 0.50 • n=5 Participants	36.6 degrees (C) STANDARD_DEVIATION 0.46 • n=7 Participants	36.5 degrees (C) STANDARD_DEVIATION 0.48 • n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Intention to Treat Population

Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability

Outcome measures

Measure	Group1: IV t-PA and Normothermia n=55 Participants IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=63 Participants IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
The Primary Outcome is the Proportion of Patients Achieving a Favorable Outcome Defined as Modified Rankin Scale Score of 0 or 1, Assessed 90 Days After Treatment.	21 participants	21 participants

PRIMARY outcome

Timeframe: 48 hours

Population: Intention to treat patients with imaging obtained 36 to 48 hours after treatment

Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.

Outcome measures

Measure	Group1: IV t-PA and Normothermia n=57 Participants IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=63 Participants IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset	13 participants	9 participants

PRIMARY outcome

Timeframe: 48 hours

Population: ITT patients in whom a brain image was obtained 36 yo 48 hours after treatment

Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.

Outcome measures

Measure	Group1: IV t-PA and Normothermia n=57 Participants IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=63 Participants IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset	2 participants	1 participants

PRIMARY outcome

Timeframe: 7 days or discharge whichever comes first

Population: ITT population

Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness

Outcome measures

Measure	Group1: IV t-PA and Normothermia n=57 Participants IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=63 Participants IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
Incidence of Pneumonia	6 participants	12 participants

PRIMARY outcome

Timeframe: 90 days

Population: ITT population

Mortality prior to the 90-day evaluation.

Outcome measures

Measure	Group1: IV t-PA and Normothermia n=57 Participants IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=63 Participants IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
90 Day Mortality	5 participants	10 participants

SECONDARY outcome

Timeframe: 90 days

Population: The intention to treat population with a 90-day Barthel index available was used, therefore the numbers are fewer than in the total population.

The Barthel index measures independence in activities of daily living from 0 (worst) to 100 (best) in 5 point increments. Higher scores between 0 and 100 reflect progressively greater levels of independence. Scores were dichotomized at 90 so that a score of 95 or 100 was considered a successful treatment.

Outcome measures

Measure	Group1: IV t-PA and Normothermia n=46 Participants IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=49 Participants IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
The Barthel Index Measure of Activities of Daily Living;	25 participants	24 participants

SECONDARY outcome

Timeframe: 90 days

Population: Intention to treat patients with an available 90-day NIHSS values therefore the total numbers available are fewer than the total ITT population.

The National Institutes of Health Stroke Scale (NIHSS) is used to quantify neurological deficit. The scale ranges from 0 (best) to 42 points (worst). Between scores of 0 to 42, higher values reflect progressively greater deficit.

Outcome measures

Measure	Group1: IV t-PA and Normothermia n=44 Participants IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=43 Participants IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.
NIHSS Scores at 90 Days	6.1 units on a scale Standard Deviation 6.6	4.8 units on a scale Standard Deviation 5.4

Adverse Events

Group1: IV t-PA and Normothermia

Serious events: 20 serious events

Other events: 53 other events

Deaths: 0 deaths

Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment

Serious events: 26 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group1: IV t-PA and Normothermia n=57 participants at risk IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=63 participants at risk IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming.
Cardiac disorders Cardiac Disorders	5.3% 3/57 • Number of events 3 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	3.2% 2/63 • Number of events 2 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Infections and infestations Infections	0.00% 0/57 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	6.3% 4/63 • Number of events 4 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Injury, poisoning and procedural complications injury	5.3% 3/57 • Number of events 3 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	0.00% 0/63 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Metabolism and nutrition disorders Metabolism	0.00% 0/57 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	3.2% 2/63 • Number of events 2 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Musculoskeletal and connective tissue disorders muskuloskeletal	0.00% 0/57 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	1.6% 1/63 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	1.8% 1/57 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	0.00% 0/63 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Nervous system disorders Nervous System Disorders	22.8% 13/57 • Number of events 17 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	20.6% 13/63 • Number of events 13 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Psychiatric disorders psychiatric disorders	0.00% 0/57 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	1.6% 1/63 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Renal and urinary disorders renal	0.00% 0/57 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	1.6% 1/63 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory	3.5% 2/57 • Number of events 3 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	14.3% 9/63 • Number of events 10 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Vascular disorders vascular	5.3% 3/57 • Number of events 4 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	1.6% 1/63 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.

Other adverse events

Measure	Group1: IV t-PA and Normothermia n=57 participants at risk IV tpa and normothermia Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia	Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment n=63 participants at risk IV tpa and hypothermia and anti-shivering treatment hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming.
Blood and lymphatic system disorders Blood and lymphatic	12.3% 7/57 • Number of events 7 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	6.3% 4/63 • Number of events 4 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Cardiac disorders Cardiac	26.3% 15/57 • Number of events 16 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	30.2% 19/63 • Number of events 33 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Endocrine disorders Endocrine	0.00% 0/57 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	9.5% 6/63 • Number of events 6 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Eye disorders Eye	3.5% 2/57 • Number of events 2 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	3.2% 2/63 • Number of events 2 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Gastrointestinal disorders GI	40.4% 23/57 • Number of events 30 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	57.1% 36/63 • Number of events 50 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
General disorders General	29.8% 17/57 • Number of events 21 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	54.0% 34/63 • Number of events 38 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Immune system disorders immune	1.8% 1/57 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	3.2% 2/63 • Number of events 2 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Infections and infestations Infection	17.5% 10/57 • Number of events 11 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	22.2% 14/63 • Number of events 14 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Injury, poisoning and procedural complications injury	10.5% 6/57 • Number of events 6 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	11.1% 7/63 • Number of events 7 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Investigations investigations	59.6% 34/57 • Number of events 83 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	82.5% 52/63 • Number of events 139 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Metabolism and nutrition disorders Metabolism	10.5% 6/57 • Number of events 6 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	17.5% 11/63 • Number of events 11 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Musculoskeletal and connective tissue disorders Muskuloskeletal	12.3% 7/57 • Number of events 8 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	17.5% 11/63 • Number of events 12 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms	1.8% 1/57 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	0.00% 0/63 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Nervous system disorders Nervous Systen	57.9% 33/57 • Number of events 54 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	58.7% 37/63 • Number of events 46 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Psychiatric disorders Psychiatric	14.0% 8/57 • Number of events 8 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	12.7% 8/63 • Number of events 8 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Renal and urinary disorders Renal	10.5% 6/57 • Number of events 6 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	7.9% 5/63 • Number of events 6 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Reproductive system and breast disorders Reproductive	1.8% 1/57 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	0.00% 0/63 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory	26.3% 15/57 • Number of events 21 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	49.2% 31/63 • Number of events 44 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Skin and subcutaneous tissue disorders Skin	3.5% 2/57 • Number of events 2 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	1.6% 1/63 • Number of events 1 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.
Vascular disorders Vascular	33.3% 19/57 • Number of events 23 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.	44.4% 28/63 • Number of events 33 • Adverse events were collected for 7 days or discharge whichever came first. Serious adverse events were collected for 90 days. Adverse events and Other (not including serious) events are summarized by system organ class, rather than Adverse Event Terms, due to the small number of subjects and infrequency of adverse events.

Additional Information

Dr. Patrick Lyden

Cedars-Sinai Medical Center

Phone: 310-423-5166

Email: lydenp@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place