Trial Outcomes & Findings for Pediatric Guideline Adherence and Outcomes- Argentina (NCT NCT03896789)

Last Updated: 2025-01-29

Results Overview

Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context. To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention).

Recruitment status

COMPLETED

Study phase

Target enrollment

505 participants

Primary outcome timeframe

ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

Results posted on

2025-01-29

Participant Flow

Participants were screened based on ICU admission at 16 South American study hospitals between September 1, 2019 and September 30, 2023. The first participant was enrolled on September 9, 2019 and the last participant was enrolled September 26, 2023.

Due to COVID-19, we reverted to a parallel-cluster design before randomization, resulting in a baseline period (9/1/19-7/13/20) with usual care data collected at all sites. Arm assignment and site notification was 7/13/20. Participants enrolled between 7/14/20-9/30/20 during intervention site training are included in the assigned arm (intention-to-treat) due to possible behavior change once assignment was known. Intervention implementation began for participants enrolled between 10/1/20-9/30/23.

Unit of analysis: Sites

Participant milestones

Participant milestones
Measure	Usual Care, Then Usual Care (Control) All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Baseline STARTED	55 8	61 8
Baseline 3-month Post-admission Follow-up	52 8	55 8
Baseline COMPLETED	51 8	53 8
Baseline NOT COMPLETED	4 0	8 0
Post-Randomization STARTED	208 8	181 8
Post-Randomization 3-month Post-admission Follow-up	196 8	168 8
Post-Randomization COMPLETED	184 8	157 8
Post-Randomization NOT COMPLETED	24 0	24 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care, Then Usual Care (Control) All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Baseline Lost to Follow-up	1	2
Baseline Death	3	6
Post-Randomization Lost to Follow-up	12	11
Post-Randomization Death	12	13

Baseline Characteristics

The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

Population: We compared control and intervention arms post-randomization (07/13/20) in statistical analysis. Baseline period data contributed to other adjusted analyses.

Outcome measures

Outcome measures
Measure	Usual Care, Then Usual Care (Control) n=263 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) n=242 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall Baseline	81.7 mean percentage of guideline adherence Standard Deviation 12.9	81.0 mean percentage of guideline adherence Standard Deviation 13.2
First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall Post-Randomization	83.7 mean percentage of guideline adherence Standard Deviation 11.5	84.4 mean percentage of guideline adherence Standard Deviation 12.8

SECONDARY outcome

Timeframe: Started within 24 hours of patient eligibility (at admission or deterioration)

Population: Analysis was intention-to-treat. Patients enrolled to the intervention arm after randomization, but before intervention implementation were still included because site investigators and sites were aware of their arm assignment from that date and could have altered behavior during the training interval before implementation start.

This outcome will be measured as yes/no for each participant at intervention sites to assess intervention delivery. In essence, the intervention started (use of PEGASUS program clinical pathway) within 24 hours of their eligibility and enrollment. Due to our intention-to-treat analysis plan, participants who enrolled after randomization but before intervention implementation at intervention sites are included in the analysis. Although they could not have implemented the intervention, sites were aware of their allocation status and were preparing and training during this interval.

Outcome measures

Outcome measures
Measure	Usual Care, Then Usual Care (Control) n=181 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Clinical Pathway Adoption Post-Randomization, Pre-Implementation	11 Participants	—
Clinical Pathway Adoption Post-Randomization, Post-Implementation Implemented Clinical Pathway	170 Participants	—
Clinical Pathway Adoption Post-Randomization, Post-Implementation Did Not Implement Clinical Pathway	0 Participants	—

SECONDARY outcome

Timeframe: Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.

Population: The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis.

Participants' GOS score at hospital discharge from medical record: Death-1 (worse) Vegetative State-2 Severe Disability-3 Moderate Disability-4 Good Recovery-5 (better) The timing varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.

Outcome measures

Outcome measures
Measure	Usual Care, Then Usual Care (Control) n=263 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) n=242 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Glasgow Outcome Scale (GOS) Score at Discharge Post-Randomization · Severe disability	18 Participants	17 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Post-Randomization · Moderate disability	24 Participants	42 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Post-Randomization · Good recovery	139 Participants	100 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Baseline · Death (all-cause)	3 Participants	6 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Baseline · Vegetative state	0 Participants	2 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Baseline · Severe disability	5 Participants	4 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Baseline · Moderate disability	3 Participants	19 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Baseline · Good recovery	44 Participants	30 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Post-Randomization · Death (all-cause)	12 Participants	13 Participants
Glasgow Outcome Scale (GOS) Score at Discharge Post-Randomization · Vegetative state	15 Participants	9 Participants

SECONDARY outcome

Number of survivors at intervention and control sites (descriptive and not powered for this outcome).

Outcome measures

Outcome measures
Measure	Usual Care, Then Usual Care (Control) n=263 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) n=242 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Discharge Survival Baseline · Died in-hospital	3 Participants	6 Participants
Discharge Survival Baseline · Survived	52 Participants	55 Participants
Discharge Survival Post-Randomization · Died in-hospital	12 Participants	13 Participants
Discharge Survival Post-Randomization · Survived	196 Participants	168 Participants

SECONDARY outcome

Timeframe: 3 months post-admission

Population: 3-month outcome assessment among those who survived (enrolled participants less those who died in-hospital) and reached for follow-up. Lost-to-follow-up noted in Participant Flow.

We will examine participants' recovery using GOSE-Peds scores. These were assessed by site study staff either in-person, by telephone, or from medical record approximately 3 months after the admission date. Death-8 (worse) Vegetative State-7 Severe Disability lower-6 Severe Disability upper-5 Moderate Disability lower-4 Moderate Disability upper-3 Good Recovery lower-2 Good Recovery upper-1 (better)

Outcome measures

Outcome measures
Measure	Usual Care, Then Usual Care (Control) n=235 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) n=210 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Baseline · Good recovery-upper	32 Participants	27 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Post-Randomization · Good recovery-lower	26 Participants	26 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Baseline · Death	0 Participants	0 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Baseline · Vegetative state	0 Participants	2 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Baseline · Severe disability-lower	5 Participants	8 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Baseline · Severe disability-upper	7 Participants	10 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Baseline · Moderate disability-lower	0 Participants	1 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Baseline · Moderate disability-upper	4 Participants	1 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Baseline · Good recovery-lower	3 Participants	4 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Post-Randomization · Death	0 Participants	0 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Post-Randomization · Vegetative state	6 Participants	9 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Post-Randomization · Severe disability-lower	27 Participants	25 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Post-Randomization · Severe disability-upper	11 Participants	17 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Post-Randomization · Moderate disability-lower	4 Participants	4 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Post-Randomization · Moderate disability-upper	9 Participants	8 Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) Post-Randomization · Good recovery-upper	101 Participants	68 Participants

SECONDARY outcome

Timeframe: 3 months post admission

We will examine participants' mortality at 3 months post discharge

Outcome measures

Outcome measures
Measure	Usual Care, Then Usual Care (Control) n=235 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) n=210 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Mortality, 3-Month Baseline · Died	0 Participants	0 Participants
Mortality, 3-Month Baseline · Survived	51 Participants	53 Participants
Mortality, 3-Month Post-Randomized · Died	0 Participants	0 Participants
Mortality, 3-Month Post-Randomized · Survived	184 Participants	157 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

Population: We compared control and intervention arms post-randomization (07/13/20) in statistical analysis by extracranial injury status.

Outcome measures

Outcome measures
Measure	Usual Care, Then Usual Care (Control) n=263 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care, Then PEGASUS Program (Intervention) n=242 Participants All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status Baseline, Isolated TBI (non-head AIS=0)	80.2 mean percentage of guideline adherence Standard Deviation 12.1	84.3 mean percentage of guideline adherence Standard Deviation 12.2
Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status Baseline, Extracranial injury (non-head AIS>0)	83.0 mean percentage of guideline adherence Standard Deviation 13.4	79.6 mean percentage of guideline adherence Standard Deviation 13.4
Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status Post-Randomization, Isolated TBI (non-head AIS=0)	81 mean percentage of guideline adherence Standard Deviation 13.9	86.2 mean percentage of guideline adherence Standard Deviation 12.4
Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status Post-Randomization, Extracranial injury (non-head AIS>0)	84.8 mean percentage of guideline adherence Standard Deviation 10.2	84.0 mean percentage of guideline adherence Standard Deviation 12.9

Adverse Events

Usual Care at Baseline (Site That Was Later Assigned to the Control)

Serious events: 6 serious events

Other events: 21 other events

Deaths: 3 deaths

Usual Care at Post-Randomization Control Site

Serious events: 34 serious events

Other events: 72 other events

Deaths: 12 deaths

Usual Care at Baseline (Site That Was Later Assigned to the Intervention)

Serious events: 7 serious events

Other events: 16 other events

Deaths: 6 deaths

PEGASUS Program at Post-Randomization Intervention Site

Serious events: 17 serious events

Other events: 78 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care at Baseline (Site That Was Later Assigned to the Control) n=55 participants at risk All participants received Usual Care. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Data for Adverse Events from the Baseline period (9/1/19-7/13/20) are listed here. See Outcomes for Mortality separated by study period.	Usual Care at Post-Randomization Control Site n=208 participants at risk All participants received Usual Care. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Data for Adverse Events from the Post-Randomization period (7/14/20-9/30/23) are listed here. See Outcomes for Mortality separated by study period. Sites will receive the opportunity for the PEGASUS program training (intervention) after the end of study.	Usual Care at Baseline (Site That Was Later Assigned to the Intervention) n=61 participants at risk All participants received Usual Care. This arm (8 sites) was randomized to PEGASUS (intervention) on 7/13/2020. Data for Adverse Events from the Baseline period (9/1/19-7/13/20) are listed here. See Outcomes for Mortality separated by study period.	PEGASUS Program at Post-Randomization Intervention Site n=181 participants at risk All participants received the PEGASUS Program in addition to Usual Care. This arm (8 sites) was randomized to PEGASUS (intervention) on 7/13/2020. Data for Adverse Events from the Post-Randomization period (7/14/20-9/30/23) are listed here. See Outcomes for Mortality separated by study period. Intervention site training occurred before the intervention was implemented for participants admitted beginning 10/1/2020. Participants in the Post-Randomization were intention-to-treat once site arm was assigned. Participants in this study period received Usual Care while site were receiving pre-implementation training, after implementation, participants received Usual Care and the PEGASUS Program. See Outcomes for Mortality separated by study period. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
Infections and infestations Pneumonia	1.8% 1/55 • Number of events 1 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	4.3% 9/208 • Number of events 12 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	1.6% 1/61 • Number of events 1 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	2.8% 5/181 • Number of events 5 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Cardiac disorders Arrhythmia	0.00% 0/55 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.96% 2/208 • Number of events 5 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/61 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.55% 1/181 • Number of events 1 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
General disorders Shock	7.3% 4/55 • Number of events 4 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	8.2% 17/208 • Number of events 23 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	4.9% 3/61 • Number of events 4 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	4.4% 8/181 • Number of events 8 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Infections and infestations Peritonitis	0.00% 0/55 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/208 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/61 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/181 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Nervous system disorders Intraparenchymal hemorrhage	3.6% 2/55 • Number of events 2 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	1.4% 3/208 • Number of events 3 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	1.6% 1/61 • Number of events 1 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	1.1% 2/181 • Number of events 2 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Respiratory, thoracic and mediastinal disorders Other: Respiratory	3.6% 2/55 • Number of events 3 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	1.4% 3/208 • Number of events 3 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	3.3% 2/61 • Number of events 2 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/181 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Nervous system disorders Other: Neurological	0.00% 0/55 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	5.8% 12/208 • Number of events 15 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	1.6% 1/61 • Number of events 1 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	2.2% 4/181 • Number of events 10 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Metabolism and nutrition disorders Other: Electrolyte/Metabolic	0.00% 0/55 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	1.9% 4/208 • Number of events 9 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/61 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.55% 1/181 • Number of events 2 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Cardiac disorders Other: Cardiac	0.00% 0/55 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.48% 1/208 • Number of events 1 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/61 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/181 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Blood and lymphatic system disorders Other: Hematology	0.00% 0/55 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/208 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/61 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/181 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.
Infections and infestations Other: Infectious	0.00% 0/55 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.96% 2/208 • Number of events 2 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.00% 0/61 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.	0.55% 1/181 • Number of events 1 • Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study. Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant. Other was free text classified into organ system by investigators.

Other adverse events

Additional Information

Dr. Monica S. Vavilala

University of Washington

Phone: 206-744-7235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place