Trial Outcomes & Findings for ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium (NCT NCT00300391)

NCT ID: NCT00300391

Last Updated: 2017-12-20

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

Daily

Results posted on

2017-12-20

Participant Flow

This study was pre-maturely terminated and although sincere efforts were made to locate the relevant (and accurate) data for results reporting, limited data could be obtained and are reported in the Results section. Some data were either missing or were conflicting and were therefore, excluded.

7 of 40 enrolled subjects never developed delirium, while 2 of 40 had persistent coma and died without ever opening eyes. Subjects were randomized to groups once the delirium was diagnosed. 31 subjects developed delirium and were eligible to randomized. 1 withdrew before starting/being randomized, as a result, 30 subjects were randomized.

Participant milestones

Participant milestones
Measure	Haloperidol Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.	Placebo Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
Overall Study STARTED	16	14
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Haloperidol n=16 Participants Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.	Placebo n=14 Participants Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.	Total n=30 Participants Total of all reporting groups
Age, Customized >=18 Years	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Daily

Population: This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the "Delirium," "Persistent Coma," and "No delirium".

Outcome measures

Outcome measures
Measure	Delirium n=30 Participants Once diagnosed as delirious, randomized to haloperidol 5 mg IV haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.	Persistent Coma n=2 Participants	No Delirium n=7 Participants
28-day All-cause Mortality	4 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 90 Days from enrollment in study

Outcome measures

Outcome measures
Measure	Delirium n=30 Participants Once diagnosed as delirious, randomized to haloperidol 5 mg IV haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.	Persistent Coma n=2 Participants	No Delirium n=7 Participants
90-day All-cause Mortality	4 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: daily

Outcome measures

Outcome measures
Measure	Delirium n=30 Participants Once diagnosed as delirious, randomized to haloperidol 5 mg IV haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.	Persistent Coma n=2 Participants	No Delirium n=7 Participants
Duration of Mechanical Ventilation	4.5 day Interval 3.0 to 10.0	6 day Interval 4.0 to 8.0	4 day Interval 2.0 to 13.0

SECONDARY outcome

Timeframe: Daily

Outcome measures

Outcome measures
Measure	Delirium n=30 Participants Once diagnosed as delirious, randomized to haloperidol 5 mg IV haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.	Persistent Coma n=2 Participants	No Delirium n=7 Participants
ICU Length of Stay	9 day Interval 5.0 to 14.0	6 day Interval 4.0 to 8.0	7 day Interval 6.0 to 16.0

Adverse Events

Haloperidol

Serious events: 0 serious events

Other events: 16 other events

Deaths: 1 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Barb Early, RN, BSN, CCRC

UPittsburgh

Phone: (412) 647-9745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Haloperidol n=16 participants at risk Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.	Placebo n=13 participants at risk Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
Cardiac disorders Elevated QTc .494	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Cardiac disorders Elevated QTc .505	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Cardiac disorders Elevated QTc 548	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Cardiac disorders Elevated QTc 520	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Hypoxemic resp failure ARDS	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Infections and infestations Cellulitis	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Nosocomial pneumonia	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders RUL collapse	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Bilateral infiltrates	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Trachestomy	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	15.4% 2/13 • Number of events 2 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Surgical and medical procedures Abdominal surgery (closure)	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Intrapulmonary hemorrhage	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Tachycardia, restlessness desat	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Surgical and medical procedures OR-cleansing and closure of leg wound	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Lower lobectomy	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Self extubation with continued resp. insufficiency	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Gastrointestinal disorders GU hemorrhage related to selfremoval of Foley catheter	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Reintubated for resp. insufficiency	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Failure to wean from ventilator	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Pseudomonas pneumonia	12.5% 2/16 • Number of events 2 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Infections and infestations MRSA	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Renal and urinary disorders ARF	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Cardiac disorders VTach	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Vascular disorders Hypertension	12.5% 2/16 • Number of events 2 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Viral pneumonia, ARDS	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Vascular disorders Lower extremity DVT	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Psychiatric disorders Agitation/delirium	25.0% 4/16 • Number of events 4 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Vascular disorders Hypotension	12.5% 2/16 • Number of events 2 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Cardiac disorders A Fib	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Apnea/desaturation during weaning	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Sedation interruption associated with desaturation and tachycardia	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Blood and lymphatic system disorders Anemia	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Gastrointestinal disorders Gastritis	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Blood and lymphatic system disorders Azotemia	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Renal and urinary disorders Urinary tract infection	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Blood and lymphatic system disorders Chronic hyponatremia	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Gastrointestinal disorders Gastric and duodenal ulcers	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Respiratory, thoracic and mediastinal disorders Polymicrobial bilateral pneumonia	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	0.00% 0/13 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Hepatobiliary disorders Hepatic encephalopathy	6.2% 1/16 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	7.7% 1/13 • Number of events 1 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.
Infections and infestations Sepsis	0.00% 0/16 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.	23.1% 3/13 • Number of events 3 • Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was. All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.