Trial Outcomes & Findings for Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome (NCT NCT02582957)

Last Updated: 2024-06-06

Results Overview

Ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation. Patients who died before day 28 were assigned 0 VFDs as were those transferred to a long-term care facility while ventilated.

Recruitment status

COMPLETED

Study phase

Target enrollment

524 participants

Primary outcome timeframe

28 days

Results posted on

2024-06-06

Participant Flow

Patients were recruited in 15 trauma centers in the United States from April, 2016, to September, 2022.

All analyses were based on the intention-to-treat principle. Participants were included in the primary analysis if primary endpoint data was available (ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation).

Participant milestones

Participant milestones
Measure	Sigh Breaths Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.
Overall Study STARTED	261	263
Overall Study COMPLETED	259	261
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data based on available medical records

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sigh Breaths n=261 Participants Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care n=263 Participants Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.	Total n=524 Participants Total of all reporting groups
Age, Continuous Age	43.7 years STANDARD_DEVIATION 19.1 • n=261 Participants	44.2 years STANDARD_DEVIATION 19.2 • n=263 Participants	43.9 years STANDARD_DEVIATION 19.2 • n=524 Participants
Sex: Female, Male Female	64 Participants n=261 Participants	66 Participants n=263 Participants	130 Participants n=524 Participants
Sex: Female, Male Male	197 Participants n=261 Participants	197 Participants n=263 Participants	394 Participants n=524 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=261 Participants	42 Participants n=263 Participants	85 Participants n=524 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	218 Participants n=261 Participants	221 Participants n=263 Participants	439 Participants n=524 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=261 Participants	0 Participants n=263 Participants	0 Participants n=524 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=261 Participants	0 Participants n=263 Participants	2 Participants n=524 Participants
Race (NIH/OMB) Asian	1 Participants n=261 Participants	4 Participants n=263 Participants	5 Participants n=524 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=261 Participants	0 Participants n=263 Participants	0 Participants n=524 Participants
Race (NIH/OMB) Black or African American	55 Participants n=261 Participants	52 Participants n=263 Participants	107 Participants n=524 Participants
Race (NIH/OMB) White	202 Participants n=261 Participants	203 Participants n=263 Participants	405 Participants n=524 Participants
Race (NIH/OMB) More than one race	0 Participants n=261 Participants	3 Participants n=263 Participants	3 Participants n=524 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=261 Participants	1 Participants n=263 Participants	2 Participants n=524 Participants
Region of Enrollment United States	261 participants n=261 Participants	263 participants n=263 Participants	524 participants n=524 Participants
Smoking status Current/Past	134 Participants n=261 Participants	103 Participants n=263 Participants	237 Participants n=524 Participants
Smoking status Never	65 Participants n=261 Participants	80 Participants n=263 Participants	145 Participants n=524 Participants
Smoking status Unknown/Missing	62 Participants n=261 Participants	80 Participants n=263 Participants	142 Participants n=524 Participants
Arterial blood gas pH	7.36 pH STANDARD_DEVIATION 0.08 • n=234 Participants • Data based on available medical records	7.37 pH STANDARD_DEVIATION 0.08 • n=243 Participants • Data based on available medical records	7.36 pH STANDARD_DEVIATION 0.08 • n=477 Participants • Data based on available medical records
Arterial blood gas PaCO2	39.1 mmHg STANDARD_DEVIATION 7.4 • n=234 Participants • Data based on available medical records	38.6 mmHg STANDARD_DEVIATION 7.8 • n=243 Participants • Data based on available medical records	38.9 mmHg STANDARD_DEVIATION 7.6 • n=477 Participants • Data based on available medical records
Arterial blood gas PaO2	157.4 mmHg STANDARD_DEVIATION 84.2 • n=234 Participants • Data based on available medical records	152.5 mmHg STANDARD_DEVIATION 79.9 • n=243 Participants • Data based on available medical records	154.9 mmHg STANDARD_DEVIATION 82.0 • n=477 Participants • Data based on available medical records
Arterial blood gas FIO2	48.2 mmHg STANDARD_DEVIATION 18.9 • n=230 Participants • Data based on available medical records	47.1 mmHg STANDARD_DEVIATION 17.2 • n=228 Participants • Data based on available medical records	47.6 mmHg STANDARD_DEVIATION 18.1 • n=458 Participants • Data based on available medical records
P/F ratio	347.6 Ratio STANDARD_DEVIATION 172.0 • n=230 Participants • Data based on available medical records	349.8 Ratio STANDARD_DEVIATION 214.0 • n=228 Participants • Data based on available medical records	349.2 Ratio STANDARD_DEVIATION 193.8 • n=458 Participants • Data based on available medical records
Hours on ventilator prior to randomization	17.1 hours STANDARD_DEVIATION 5.8 • n=261 Participants	17.0 hours STANDARD_DEVIATION 5.9 • n=263 Participants	17.0 hours STANDARD_DEVIATION 5.8 • n=524 Participants
Injury Severity Score	28.8 units on a scale STANDARD_DEVIATION 12.9 • n=256 Participants • Data based on available medical records	29.9 units on a scale STANDARD_DEVIATION 11.7 • n=259 Participants • Data based on available medical records	29.4 units on a scale STANDARD_DEVIATION 12.3 • n=515 Participants • Data based on available medical records
BMI	28.7 kg/m^2 STANDARD_DEVIATION 6.4 • n=261 Participants	28.4 kg/m^2 STANDARD_DEVIATION 6.5 • n=263 Participants	28.5 kg/m^2 STANDARD_DEVIATION 6.5 • n=524 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Analysis based on participants with available follow-up data

Outcome measures

Outcome measures
Measure	Sigh Breaths n=259 Participants Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care n=261 Participants Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.
Ventilator-free Days (VFDs)	18.4 days Interval 7.0 to 25.2	16.1 days Interval 1.1 to 24.4

SECONDARY outcome

Timeframe: 28 days

Population: Analysis population based on those with follow-up data available

All-cause 28 day mortality

Outcome measures

Outcome measures
Measure	Sigh Breaths n=259 Participants Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care n=261 Participants Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.
All-cause Mortality	30 Participants	46 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Analysis based on participants with available follow-up data

Number of ICU-free days to day 28 after enrollment

Outcome measures

Outcome measures
Measure	Sigh Breaths n=259 Participants Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care n=261 Participants Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.
ICU-free Days	13.7 days Interval 2.0 to 20.6	11.9 days Interval 0.0 to 20.0

SECONDARY outcome

Timeframe: 28 days

Population: Analysis based on participants with available follow-up data

Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles.

Outcome measures

Outcome measures
Measure	Sigh Breaths n=259 Participants Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care n=261 Participants Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.
Number of Participants With Complications of Treatment Pneumothorax	18 Participants	20 Participants
Number of Participants With Complications of Treatment Ventilator-associated pneumonia	57 Participants	69 Participants
Number of Participants With Complications of Treatment Hypotension requiring pressors	127 Participants	120 Participants
Number of Participants With Complications of Treatment Pneumatocele	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 28 days

Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice

Outcome measures

Outcome measures
Measure	Sigh Breaths n=261 Participants Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care n=263 Participants Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.
Discharge Status	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 28 days

Number of Participants newly requiring continuous oxygen therapy at discharge.

Outcome measures

Outcome measures
Measure	Sigh Breaths n=261 Participants Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care n=263 Participants Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.
Number of Participants Requiring Oxygen Therapy at Discharge	20 Participants	12 Participants

Adverse Events

Sigh Breaths

Serious events: 103 serious events

Other events: 0 other events

Deaths: 30 deaths

Usual Care

Serious events: 114 serious events

Other events: 0 other events

Deaths: 46 deaths

Serious adverse events

Serious adverse events
Measure	Sigh Breaths n=259 participants at risk Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.	Usual Care n=261 participants at risk Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.
Respiratory, thoracic and mediastinal disorders Pneumonia	8.5% 22/259 • Number of events 23 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	8.4% 22/261 • Number of events 23 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.9% 18/259 • Number of events 20 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	7.7% 20/261 • Number of events 22 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	3.9% 10/259 • Number of events 12 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	5.0% 13/261 • Number of events 15 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Other Respiratory	4.6% 12/259 • Number of events 12 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	4.6% 12/261 • Number of events 12 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Infections and infestations Infection	3.5% 9/259 • Number of events 10 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	4.6% 12/261 • Number of events 13 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Vascular disorders Stroke	2.7% 7/259 • Number of events 8 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	2.7% 7/261 • Number of events 9 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Gastrointestinal disorders Gastrointestinal Bleed	2.3% 6/259 • Number of events 7 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	2.3% 6/261 • Number of events 6 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Cardiovascular	2.3% 6/259 • Number of events 6 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	2.3% 6/261 • Number of events 6 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Infections and infestations Septic Shock	2.7% 7/259 • Number of events 7 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	1.1% 3/261 • Number of events 4 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Hypotension	2.7% 7/259 • Number of events 7 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	0.00% 0/261 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Infections and infestations Hemorrhagic Shock	2.3% 6/259 • Number of events 6 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	1.9% 5/261 • Number of events 5 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Nervous system disorders Brain Injury	8.1% 21/259 • Number of events 21 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	11.9% 31/261 • Number of events 31 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
General disorders Other	3.1% 8/259 • Number of events 9 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.	3.8% 10/261 • Number of events 11 • Participants were followed for 28 days Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard Albert

University of Colorado

Phone: 303-602-5011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place