Trial Outcomes & Findings for Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial (NCT NCT00878644)

Last Updated: 2017-09-29

Results Overview

Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

295 participants

Primary outcome timeframe

Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.

Results posted on

2017-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Therapeutic Hypothermia Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Overall Study STARTED	155	140
Overall Study COMPLETED	151	136
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapeutic Hypothermia n=155 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=140 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.	Total n=295 Participants Total of all reporting groups
Age, Continuous	2.1 years n=5 Participants	1.6 years n=7 Participants	2.0 years n=5 Participants
Age, Customized Age Category · < 2 yr	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Age, Customized Age Category · 2 - <12 yr	48 Participants n=5 Participants	45 Participants n=7 Participants	93 Participants n=5 Participants
Age, Customized Age Category · 12 - 17 yr	31 Participants n=5 Participants	22 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	46 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	94 Participants n=7 Participants	196 Participants n=5 Participants

PRIMARY outcome

Timeframe: Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.

Population: Subjects with baseline VABS-II \>= 70, OR unavailable baseline VABS-II but Pediatric Overall Performance Category (POPC) score and Pediatric Cerebral Overall Performance Category (PCPC) both reflecting none or mild disability (1 or 2), are eligible for the primary analysis. Population is analysis-eligible patients with available primary outcome.

Outcome measures

Outcome measures
Measure	Therapeutic Hypothermia n=138 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=122 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Survival With Good Neurobehavioral Outcome Alive with VABS-II >=70 at 1 year	27 Participants	15 Participants
Survival With Good Neurobehavioral Outcome Died or Alive with VABS-II <70 at 1 year	111 Participants	107 Participants

SECONDARY outcome

Timeframe: Measured at one-year anniversary of cardiac arrest.

Population: All randomized patients with available vital status (alive or deceased) at one year after cardiac arrest.

Survival at one year after cardiac arrest

Outcome measures

Outcome measures
Measure	Therapeutic Hypothermia n=151 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=136 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Survival Alive at 1 year	57 Participants	39 Participants
Survival Died at 1 year	94 Participants	97 Participants

SECONDARY outcome

Population: All randomized subjects with available data for this outcome (this implies a child must be either dead at 1 year, have the lowest possible value for the VABS-II score at 1 year, or if neither of these two criteria applies, must have both baseline VABS-II and 1-year VABS-II scores available to allow calculation of change in VABS-II score)

Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome.

Outcome measures

Outcome measures
Measure	Therapeutic Hypothermia n=151 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=134 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest Dead at 1 year	94 Participants	97 Participants
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest Lowest possible VABS-II at 1 year	6 Participants	1 Participants
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest 1-year decrease in VABS-II >30 points	19 Participants	15 Participants
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest 1-year decrease in VABS-II 16-30 points	11 Participants	4 Participants
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest 1-year decrease in VABS-II <=15 points or improved	21 Participants	17 Participants

SECONDARY outcome

Timeframe: Measured at Month 12

Population: Randomized children alive at one year with neuropsychological score available.

Functioning, as assessed by the Mullen Early Learning Composite (for children age \< 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined.

Outcome measures

Outcome measures
Measure	Therapeutic Hypothermia n=52 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=35 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Neuropsychological Scores (for Participants That Survive) Lowest possible score	27 Participants	17 Participants
Neuropsychological Scores (for Participants That Survive) <70 (well below average)	7 Participants	8 Participants
Neuropsychological Scores (for Participants That Survive) 70 - 84 (below average)	5 Participants	6 Participants
Neuropsychological Scores (for Participants That Survive) 85 - 115 (average)	8 Participants	2 Participants
Neuropsychological Scores (for Participants That Survive) >115 (above average)	5 Participants	2 Participants

Adverse Events

Therapeutic Hypothermia

Serious events: 98 serious events

Other events: 145 other events

Deaths: 92 deaths

Therapeutic Normothermia

Serious events: 102 serious events

Other events: 124 other events

Deaths: 96 deaths

Serious adverse events

Other adverse events

Additional Information

Marianne Gildea, BSN, MS; Director of THAPCA Trials

University of Utah

Phone: 801-608-4907

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Therapeutic Hypothermia n=153 participants at risk Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=139 participants at risk Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
General disorders Shivering	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Bigeminy	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Bradycardia	2.0% 3/153 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	2.2% 3/139 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Cardiac arrest	3.3% 5/153 • Number of events 6 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	6.5% 9/139 • Number of events 10 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Cardiac failure	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	2.2% 3/139 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Cardiac failure aggravated	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	1.4% 2/139 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Myocarditis	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Pulseless electrical activity	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Torsades de pointes	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Ventricular tachycardia	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Endocrine disorders Diabetes insipidus	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	1.4% 2/139 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Eye disorders Anisocoria	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
General disorders Multi organ failure	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
General disorders Multi-organ disorder	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
General disorders Multi-organ failure	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
General disorders Multiorgan failure	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
General disorders Multiple organ failure	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	1.4% 2/139 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
General disorders Sudden infant death syndrome	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Hepatobiliary disorders Liver failure	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Candida albicans infection	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Infection pseudomonas aeruginosa	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Respiratory infection	2.6% 4/153 • Number of events 4 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	3.6% 5/139 • Number of events 6 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Sepsis	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Septic shock	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Streptococcal infection	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Tracheitis	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Infections and infestations Urinary infection	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Injury, poisoning and procedural complications Brain herniation	3.3% 5/153 • Number of events 5 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	3.6% 5/139 • Number of events 5 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Injury, poisoning and procedural complications Brain stem herniation	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Investigations Cardiac output decreased	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Investigations HIE	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Investigations QT interval prolonged	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Investigations Sputum culture positive	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Investigations Urine culture positive	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	1.4% 2/139 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Metabolism and nutrition disorders Hypocalcemia	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Metabolism and nutrition disorders Hypoglycemia	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.

Other adverse events
Measure	Therapeutic Hypothermia n=153 participants at risk Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=139 participants at risk Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Blood and lymphatic system disorders Anemia	19.6% 30/153 • Number of events 32 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	12.9% 18/139 • Number of events 19 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Clotting	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Coagulation disorder	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Coagulopathy	10.5% 16/153 • Number of events 16 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	6.5% 9/139 • Number of events 9 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders DIC	2.0% 3/153 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	1.4% 2/139 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Hypercoagulation	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Leukocytosis	3.3% 5/153 • Number of events 5 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	3.6% 5/139 • Number of events 5 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Leukopenia	5.9% 9/153 • Number of events 9 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	1.4% 2/139 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Lymphopenia	3.3% 5/153 • Number of events 5 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Methemoglobinemia	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Neutropenia	2.6% 4/153 • Number of events 4 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Splenic infarction	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Blood and lymphatic system disorders Thrombocytopenia	10.5% 16/153 • Number of events 16 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	1.4% 2/139 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders 2nd degree heart block	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Arrhythmia	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Atrial arrhythmia	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Atrial flutter	0.65% 1/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Atrial tachycardia	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Bigeminy	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Bradycardia	7.8% 12/153 • Number of events 12 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	3.6% 5/139 • Number of events 5 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Bundle branch block	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Cardiac failure	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Cardiac ischemia	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Cardiomegaly	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Fibrosis myocardial	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Junctional arrhythmia	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Junctional rhythm	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Left ventricular dysfunction	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Mitral regurgitation	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Myocardial depression	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders PVC's	2.0% 3/153 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Pericardial effusion	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Pneumopericardium	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Premature ventricular contractions	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Right ventricular dysfunction	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders SVT	1.3% 2/153 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Sinus tachycardia	0.00% 0/153 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.72% 1/139 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.
Cardiac disorders Stenosis pulmonic valve	0.65% 1/153 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.	0.00% 0/139 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 153 patients receiving Therapeutic Hypothermia and 139 patients receiving Therapeutic Normothermia. For all-cause mortality, denominators additionally include only those with known 12-month vital status.