Ganciclovir to Prevent Reactivation of Cytomegalovirus in... | NCT04706507

ID	Type	Description	Link
1UG3HL147011-01A1	U.S. NIH Grant/Contract		View source
10547	Other Identifier	Fred Hutch

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Label	Type	Description	Intervention Names
IV Ganciclovir	Experimental	5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge	Drug: IV Ganciclovir
Placebo	Placebo Comparator	normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge	Drug: Normal saline

Name	Type	Description	Arm Group Labels	Other Names
IV Ganciclovir	Drug	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.

Measure	Description	Time Frame
Respiratory-support-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure	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.	up to 28 days

Measure	Description	Time Frame
To Evaluate Whether Administration of Ganciclovir Increases Ventilator-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure.	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.	up to 28 study days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject/next of kin informed consent
Age > 18 years
CMV IgG seropositive by lateral flow assay (LFA) or standard serologic methods
Receiving care in an ICU
Acute respiratory failure as defined in Section 4.1.1.
Expected to require respiratory support for at least 2 more days after randomization
Infection confirmed or suspected by the treating clinician and felt to be the source of acute respiratory failure (Respiratory failure associated with infection confers at least 2 SOFA points above assumed baseline SOFA score of 0, thereby meeting Sepsis-3 definition).

Exclusion Criteria:

Known or suspected immunosuppression, including:
- HIV+ (i.e. prior positive test or clinical signs of suspicion of HIV/AIDS; a negative HIV test is not required for enrollment)
- stem cell transplantation:
  - within 6 months after autologous transplantation or
  - within 1 years after allogeneic transplantation (regardless of immunosuppression)
  - greater than 1 year of allogeneic transplantation if still taking systemic immunosuppression or prophylactic antibiotics (e.g. for chronic graft versus host disease) Note: if details of stem cell transplantation are unknown, patients who do not take systemic immunosuppression and do not take anti-infective prophylaxis are acceptable for enrollment and randomization.
- solid organ transplantation with receipt of systemic immunosuppression (any time)
- cytotoxic anti-cancer chemotherapy within the past three months (Note: next-of-kin estimate is acceptable)
- congenital immunodeficiency requiring antimicrobial prophylaxis (e.g. TMP-SMX, dapsone, antifungal drugs, intravenous immunoglobulin)
- receipt of one or more of the following in the indicated time period (see Appendix C):
  - within 6 months: alemtuzumab, antithymocyte/antilymphocyte antibodies, or other immunosuppressive drugs associated with CMV reactivation Note: if no information on these agents is available in the history and no direct or indirect evidence exists from the history that any condition exists that requires treatment with these agents (based on the investigator's assessment), the subject may be enrolled. For all drug information, next-of-kin estimates are acceptable. See Appendix C for commonly prescribed immunosuppressive agents. Information on the use of biologics with moderate immunosuppressive effect but no known effect on CMV are permitted and will be recorded in the CRFs.
Expected to survive < 72 hours (in the opinion of the investigator)
Has been hospitalized for > 120 hours (subjects who are transferred from a chronic care ward, such as a rehabilitation unit, with an acute event are acceptable).
Pregnant or breastfeeding (either currently or expected within one month). Note: for women of childbearing age (18-60 years, unless documentation of surgical sterilization [hysterectomy, tubal ligation, oophorectomy]), if a pregnancy test has not been done as part of initial ICU admission work-up, it will be ordered stat and documented to be negative before randomization. Both urine and blood tests are acceptable.
Absolute neutrophil count < 1,000/mm3 (if no ANC value is available, the WBC must be > 2500/mm3)
Use of anti-CMV drugs (cidofovir, letermovir, foscarnet, valganciclovir, ganciclovir) within seven (7) days of patient randomization.
Currently enrolled in an interventional trial of an investigational therapeutic agent known or suspected to have anti-CMV activity or to be associated with significant known hematologic toxicity (prior approval required).
At baseline patients who have both a tracheostomy, and have been on continuous 24-hour chronic mechanical ventilation.
Patients with Child Class C Cirrhosis.
Patients with severe (requiring home oxygen) pre-existing interstitial lung disease.
Allergy to ganciclovir
Incarcerated

Name	Affiliation	Role
Michael Boeckh, MD	Fred Hutchinson Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Denver		Denver	Colorado	80204	United States
Johns Hopkins University

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan: Protocol	Jul 23, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Respiratory-support-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure

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.

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

Posted

Mean

Standard Deviation

days

up to 28 days

ID	Title	Description
OG000	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.
OG001	Placebo	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.

Units	Counts
Participants	OG000105 OG00196

Title

Denominators

Categories

Title	Measurements
	OG00012.1± 11.1 OG00114.6± 10.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis is that there is no significant difference in the number of respiratory support free days between the active drug arm and the placebo drug arm based on the student's t-test.	t-test, 2 sided		0.098														Superiority

Secondary

To Evaluate Whether Administration of Ganciclovir Increases Ventilator-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure.

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.

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

Posted

Mean

Standard Deviation

days not on mechanical ventilation

up to 28 study days

ID	Title	Description
OG000	IV Ganciclovir	5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge
OG001	Placebo	normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge

Units	Counts
Participants	OG000

Secondary

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

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.

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

Posted

Mean

Standard Deviation

days

up to 28 days

ID	Title	Description
OG000	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.
OG001	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.

Secondary

To Evaluate Whether Mortality and Time to Death in the 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.

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.

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

Posted

Count of Participants

Participants

at study day 28

ID	Title	Description
OG000	IV Ganciclovir	5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge
OG001	Placebo	normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge

Units	Counts
Participants	OG000

Secondary

To Evaluate Whether Mortality and Time to Death in the 180 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.

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).

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

Posted

Count of Participants

Participants

at the final study visit (day 180)

ID	Title	Description
OG000	IV Ganciclovir	5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge
OG001	Placebo	normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge

Units	Counts
Participants	OG000

Secondary

To Evaluate Whether Duration of Mechanical Ventilation Among Survivors in the First 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients.

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.

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

Posted

Mean

Standard Deviation

days on mechanical ventilation

up to 28 days

ID	Title	Description
OG000	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.
OG001	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.

Secondary

To Evaluate Whether Duration of Respiratory Support Among Survivors in the First 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients.

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.

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

Posted

Mean

Standard Deviation

days on respiratory support

up to 28 days

ID	Title	Description
OG000	IV Ganciclovir	5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge
OG001	Placebo	normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge

Units	Counts
Participants	OG000

Secondary

To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients.

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.

Posted

Mean

Standard Deviation

PaO2/FiO2

up to 7 days

ID	Title	Description
OG000	IV Ganciclovir	5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge
OG001	Placebo	normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge

Units	Counts
Participants	OG000

Secondary

To Evaluate Whether ICU-free Days in the First 28 Days Are Different Among Ganciclovir Recipients Relative to Placebo Recipients.

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.

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

Posted

Mean

Standard Deviation

days

up to 28 days

ID	Title	Description
OG000	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.
OG001	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.

Secondary

To Evaluate Whether CMV DNA Detection in Plasma and Endotracheal Aspirate (ETA) by Day 28 is Different Among Ganciclovir Recipients Relative to Placebo Recipients.

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.

Participants who tested CMV negative at baseline

Posted

Count of Participants

Participants

up to 28 days

ID	Title	Description
OG000	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.
OG001	Placebo	normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge Normal saline: 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.

Secondary

To Assess the Number and Severity of Adverse Events and Serious Adverse Events in the First 28 Days in Both Groups.

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.

Posted

Count of Participants

Participants

up to 28 days

ID	Title	Description
OG000	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.
OG001	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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected99 at risk
Acute cardiac event	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Cardiac arrest	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected99 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Vision blurred	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Peptic ulcer perforation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0010 events0 affected99 at risk
Sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Septic shock	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0013 events3 affected99 at risk
Haemoglobin decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Lipase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Liver function test increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Neutrophil count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Brain oedema	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Seizure	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Subacute inflammatory demyelinating polyneuropathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Delirium	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Urinary retention	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected106 at risk EG0010 events0 affected99 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected99 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected99 at risk
Embolism	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Haematoma	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected99 at risk
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected106 at risk EG0010 events0 affected99 at risk
Hypotension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0011 events1 affected99 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected99 at risk

ID	Term
D000212	Acyclovir
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	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.
BG001	Placebo	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IV Ganciclovir	5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge	45	106	0	106	22	106
EG001	Placebo	normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge	22	99	0	99	18	99