Trial Outcomes & Findings for Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis (NCT NCT04706507)

Last Updated: 2025-12-12

Results Overview

To evaluate whether administration of ganciclovir increases respiratory-support-free days in immunocompetent patients with sepsis-associated acute respiratory failure. The outcome is the number of days the participant is not on respiratory support in the first 28 study days. This outcome uses the last-off approach to calculate the number of respiratory support days. The number of support days after calculated from the last day the participant was on respiratory support.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

205 participants

Primary outcome timeframe

up to 28 days

Results posted on

2025-12-12

Participant Flow

205 participants were enrolled at 19 U.S. clinical sites from June 29, 2021 until September 27, 2024 when the DSMB recommended early study closure.

205 participants met the eligibility criteria. They were enrolled and randomized to study treatment simultaneously.

Participant milestones

Participant milestones
Measure	IV Ganciclovir 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
Overall Study STARTED	106	99
Overall Study COMPLETED	47	59
Overall Study NOT COMPLETED	59	40

Reasons for withdrawal

Reasons for withdrawal
Measure	IV Ganciclovir 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
Overall Study Death	45	22
Overall Study Unable to adhere	0	2
Overall Study Lost to Follow-up	13	12
Overall Study Withdrawal of consent	1	1
Overall Study Patient or LAR refuses further participation	0	3

Baseline Characteristics

Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Ganciclovir n=106 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=99 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Total n=205 Participants Total of all reporting groups
Age, Continuous	63 years n=26 Participants	59 years n=24 Participants	62 years n=50 Participants
Age, Customized 18 - 20	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Age, Customized 21 - 30	5 Participants n=26 Participants	7 Participants n=24 Participants	12 Participants n=50 Participants
Age, Customized 31 - 40	8 Participants n=26 Participants	11 Participants n=24 Participants	19 Participants n=50 Participants
Age, Customized 41 - 50	13 Participants n=26 Participants	14 Participants n=24 Participants	27 Participants n=50 Participants
Age, Customized 51 - 60	21 Participants n=26 Participants	21 Participants n=24 Participants	42 Participants n=50 Participants
Age, Customized 61 - 70	27 Participants n=26 Participants	24 Participants n=24 Participants	51 Participants n=50 Participants
Age, Customized 71 - 80	28 Participants n=26 Participants	16 Participants n=24 Participants	44 Participants n=50 Participants
Age, Customized 81 +	4 Participants n=26 Participants	6 Participants n=24 Participants	10 Participants n=50 Participants
Sex: Female, Male Female	53 Participants n=26 Participants	56 Participants n=24 Participants	109 Participants n=50 Participants
Sex: Female, Male Male	53 Participants n=26 Participants	43 Participants n=24 Participants	96 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=26 Participants	4 Participants n=24 Participants	11 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants n=26 Participants	84 Participants n=24 Participants	176 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=26 Participants	11 Participants n=24 Participants	18 Participants n=50 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=26 Participants	1 Participants n=24 Participants	3 Participants n=50 Participants
Race/Ethnicity, Customized Black or African American	21 Participants n=26 Participants	20 Participants n=24 Participants	41 Participants n=50 Participants
Race/Ethnicity, Customized White	77 Participants n=26 Participants	68 Participants n=24 Participants	145 Participants n=50 Participants
Race/Ethnicity, Customized Unknown or not reported	6 Participants n=26 Participants	10 Participants n=24 Participants	16 Participants n=50 Participants
Respiratory Support On mechanical ventilation	81 Participants n=26 Participants	75 Participants n=24 Participants	156 Participants n=50 Participants
Respiratory Support On NIV	5 Participants n=26 Participants	3 Participants n=24 Participants	8 Participants n=50 Participants
Respiratory Support On HFNC	20 Participants n=26 Participants	21 Participants n=24 Participants	41 Participants n=50 Participants
Respiratory Support Missing	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
CoVID Infected Yes	9 Participants n=26 Participants	17 Participants n=24 Participants	26 Participants n=50 Participants
CoVID Infected No	97 Participants n=26 Participants	82 Participants n=24 Participants	179 Participants n=50 Participants

PRIMARY outcome

Timeframe: up to 28 days

Population: All participants enrolled, eligible, and evaluable (not replaced) and included in this primary analysis.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=105 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=96 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
Respiratory-support-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure	12.1 days Standard Deviation 11.1	14.6 days Standard Deviation 10.5

SECONDARY outcome

Timeframe: up to 28 study days

Population: Only the participants on mechanical ventilation at study entry are included. Participants on other types of respiratory support are excluded from this endpoint analysis.

During the first 28 study days, the number of days the participants are not on mechanical ventilation using the last off approach is compared between the two treatment arms.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=80 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=73 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether Administration of Ganciclovir Increases Ventilator-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure.	11.7 days not on mechanical ventilation Standard Deviation 11.1	15.3 days not on mechanical ventilation Standard Deviation 10.6

SECONDARY outcome

Timeframe: up to 28 days

Population: All participants enrolled, eligible, and evaluable (not replaced) and included in this primary analysis.

During the first 28 study days, the number of days the participants are not on any respiratory-support is compared between the two treatment arms. Instead of using last-off approach, we will count all the days during 28 days period.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=105 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=96 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether Administration of Ganciclovir Increases Total Respiratory-support-free Days (All RSFDS, Instead of Last-off Approach) in Immunocompetent Patients With Sepsis- Associated Acute Respiratory Failure	12.9 days Standard Deviation 11.1	15.2 days Standard Deviation 10.2

SECONDARY outcome

Timeframe: at study day 28

Population: Includes all participant enrolled, eligible, and evaluable (not replaced).

This is a time to event outcome with death as the event and censoring at the time of study termination if the participant is alive at 28 days. The hazard ratio and Cox proportional hazards models are used for this endpoint.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=106 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=99 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether Mortality and Time to Death in the 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	34 Participants	13 Participants

SECONDARY outcome

Timeframe: at the final study visit (day 180)

Population: Includes all participant enrolled, eligible, and evaluable (not replaced).

This is a time to event outcome with death as the event and censoring at the time of study termination if the participant is alive at the end of the study (day 180).

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=106 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=99 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether Mortality and Time to Death in the 180 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	45 Participants	22 Participants

SECONDARY outcome

Timeframe: up to 28 days

Population: Only the participants on mechanical ventilation at study entry are included. Participants on other types of respiratory support are excluded from this endpoint analysis.

This endpoint summarizes the days of mechanical ventilation for those participants who survive the first 28 days of the study. Participants who die in the first 28 days are excluded.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=52 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=62 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether Duration of Mechanical Ventilation Among Survivors in the First 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	10.0 days on mechanical ventilation Standard Deviation 8.7	10.4 days on mechanical ventilation Standard Deviation 9.3

SECONDARY outcome

Timeframe: up to 28 days

Population: Participants who survive the first 28 days of this study are included.

This endpoint summarizes the days of all types of respiratory support for those participants who survive the first 28 days of the study. Participants who die in the first 28 days are excluded.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=71 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=82 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether Duration of Respiratory Support Among Survivors in the First 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	10.1 days on respiratory support Standard Deviation 8.8	11.2 days on respiratory support Standard Deviation 9.3

SECONDARY outcome

Timeframe: up to 7 days

The PaO2/FiO2 (P/F) ratio was used to define oxygenation. The P/F ratio was summarized over the first 7 days of the study. The lowest PaO2 value within each study day was reported and used in the oxygenation calculation. If the PaO2 value was not available, an estimate of PaO2 was calculated from the SpO2 lowest value.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=106 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=99 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients. Oxygenation Day 1	155.4 PaO2/FiO2 Standard Deviation 78.4	184.8 PaO2/FiO2 Standard Deviation 132.9
To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients. Oxygenation Day 2	177.3 PaO2/FiO2 Standard Deviation 78.3	186.8 PaO2/FiO2 Standard Deviation 112.2
To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients. Oxygenation Day 3	178.9 PaO2/FiO2 Standard Deviation 72.0	186.8 PaO2/FiO2 Standard Deviation 106.5
To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients. Oxygenation Day 4	190.5 PaO2/FiO2 Standard Deviation 87.8	189.4 PaO2/FiO2 Standard Deviation 79.1
To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients. Oxygenation Day 5	184.6 PaO2/FiO2 Standard Deviation 80.3	196.3 PaO2/FiO2 Standard Deviation 80.5
To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients. Oxygenation Day 6	209.1 PaO2/FiO2 Standard Deviation 80.8	199.1 PaO2/FiO2 Standard Deviation 106.6
To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients. Oxygenation Day 7	193.5 PaO2/FiO2 Standard Deviation 81.1	198.5 PaO2/FiO2 Standard Deviation 88.2

SECONDARY outcome

Timeframe: up to 28 days

Population: All participants enrolled, eligible, and evaluable (not replaced) and included in this primary analysis.

During the first 28 study days, the number of days the participants are not in ICU using the last off approach is compared between the two treatment arms.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=105 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=95 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether ICU-free Days in the First 28 Days Are Different Among Ganciclovir Recipients Relative to Placebo Recipients.	10.9 days Standard Deviation 10.4	13.9 days Standard Deviation 9.7

SECONDARY outcome

Timeframe: up to 28 days

Population: Participants who tested CMV negative at baseline

CMV DNA detection in plasma and endotracheal aspirate (ETA) by day 28 is defined as positive CMV PCR result from any ETA, plasma, or serum specimen collected through day 28. CMV reactivation by day 28 will be summarized with number of participants with CMV reactivation in two levels: as any detectable CMV DNA (any level) and as high-level reactivation (\>1000 IU/mL) for CMV negative patients at baseline.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=85 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=77 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Evaluate Whether CMV DNA Detection in Plasma and Endotracheal Aspirate (ETA) by Day 28 is Different Among Ganciclovir Recipients Relative to Placebo Recipients. Any CMV reactivation	5 Participants	20 Participants
To Evaluate Whether CMV DNA Detection in Plasma and Endotracheal Aspirate (ETA) by Day 28 is Different Among Ganciclovir Recipients Relative to Placebo Recipients. > 1000 UI/mL	1 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 28 days

During the first 28 days, this endpoint summarizes the number of participants who experienced adverse events (AEs) of severity grade ≥3 and whether any serious adverse events (SAEs) occurred in each study arm.

Outcome measures

Outcome measures
Measure	IV Ganciclovir n=106 Participants 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.	Placebo n=99 Participants normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
To Assess the Number and Severity of Adverse Events and Serious Adverse Events in the First 28 Days in Both Groups. Participants with at least one reportable AE of grade 3 or greater	13 Participants	11 Participants
To Assess the Number and Severity of Adverse Events and Serious Adverse Events in the First 28 Days in Both Groups. Participants with at least one SAE	0 Participants	0 Participants

Adverse Events

IV Ganciclovir

Serious events: 0 serious events

Other events: 22 other events

Deaths: 45 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 22 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Michael J. Boeckh

Fred Hutch Cancer Center

Phone: 2066676706

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	IV Ganciclovir n=106 participants at risk 5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge	Placebo n=99 participants at risk normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge
Blood and lymphatic system disorders Anaemia	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Blood and lymphatic system disorders Thrombocytopenia	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	2.0% 2/99 • Number of events 2 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Cardiac disorders Acute cardiac event	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Cardiac disorders Acute myocardial infarction	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Cardiac disorders Atrial fibrillation	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Cardiac disorders Cardiac arrest	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	2.0% 2/99 • Number of events 2 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Cardiac disorders Cardiac tamponade	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Cardiac disorders Right ventricular dysfunction	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Cardiac disorders Sinus tachycardia	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Eye disorders Vision blurred	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Gastrointestinal disorders Gastric ulcer	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Gastrointestinal disorders Nausea	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Gastrointestinal disorders Peptic ulcer perforation	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
General disorders Pyrexia	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Hepatobiliary disorders Hypertransaminasaemia	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Infections and infestations Clostridium difficile colitis	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Infections and infestations Pneumonia	2.8% 3/106 • Number of events 3 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Infections and infestations Sepsis	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Infections and infestations Septic shock	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Alanine aminotransferase increased	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Aspartate aminotransferase increased	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Blood alkaline phosphatase increased	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Blood creatinine increased	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	3.0% 3/99 • Number of events 3 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Haemoglobin decreased	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Lipase increased	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Liver function test increased	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Neutrophil count decreased	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Investigations Platelet count decreased	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Metabolism and nutrition disorders Hyperkalaemia	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Metabolism and nutrition disorders Hyponatraemia	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Nervous system disorders Brain oedema	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Nervous system disorders Cerebrovascular accident	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Nervous system disorders Neuropathy peripheral	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/106 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	1.0% 1/99 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.
Nervous system disorders Seizure	0.94% 1/106 • Number of events 1 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.	0.00% 0/99 • Up to study final visit (180 days) Because critically ill patients exhibit numerous expected abnormalities, this study used a modified definition of reportable adverse events. A reportable AE is any clinically important untoward medical occurrence that (1) differs from what is expected, or (2) is considered related to the study drug or procedures, regardless of expectedness. More detail can be found in Protocol section 11.1. Note, most deaths were not reportable AEs but all deaths are included in the All Cause Mortality results.