Trial Outcomes & Findings for Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation (NCT NCT00227370)

Last Updated: 2024-10-04

Results Overview

The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

136 participants

Primary outcome timeframe

over the course of 300 days after randomization

Results posted on

2024-10-04

Participant Flow

Prospective subjects were screened and enrolled from July 2003 - January 2007 at 11 US lung transplant centers. 189 subjects were screened and 157 met inclusion criteria and were therefore enrolled in the study.

Upon receipt of a lung transplant, enrolled subjects received 90 days of valganciclovir for CMV prophylaxis, per standard of care, and then were randomly assigned, 1:1, in a double blind fashion, to either the extended prophylaxis group (9 additional months of standard of care dosing Valganciclovir, adjusted for renal function) or placebo group.

Participant milestones

Participant milestones
Measure	Placebo Group Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis). 3 months of Valganciclovir was the standard of care for CMV prevention at the time of study initiation. This was the prespecified placebo group/intervention arm.	Treatment Group Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Overall Study STARTED	66	70
Overall Study COMPLETED	45	46
Overall Study NOT COMPLETED	21	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Group Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis). 3 months of Valganciclovir was the standard of care for CMV prevention at the time of study initiation. This was the prespecified placebo group/intervention arm.	Treatment Group Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Overall Study Withdrawal by Subject	1	2
Overall Study Death	3	4
Overall Study Adverse Event	6	11
Overall Study Physician Decision	9	6
Overall Study Other reasons	2	1

Baseline Characteristics

Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=66 Participants Upon randomisation at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis	Treatment Group n=70 Participants Upon randomisation at 3 months, patients remained on Valganciclovir for 9 additional months.	Total n=136 Participants Total of all reporting groups
Age, Continuous Age	50.6 years STANDARD_DEVIATION 13.8 • n=5 Participants	51.9 years STANDARD_DEVIATION 12.2 • n=7 Participants	51.3 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	41 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	29 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	63 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
FEV1, liters	0.75 liters n=5 Participants	0.80 liters n=7 Participants	0.79 liters n=5 Participants
Indication for Lung Transplant COPD	35 subjects n=5 Participants	33 subjects n=7 Participants	68 subjects n=5 Participants
Indication for Lung Transplant Idiopathic Pulmonary Fibrosis	16 subjects n=5 Participants	16 subjects n=7 Participants	32 subjects n=5 Participants
Indication for Lung Transplant Cystic Fibrosis	11 subjects n=5 Participants	12 subjects n=7 Participants	23 subjects n=5 Participants
Indication for Lung Transplant Sarcoid	2 subjects n=5 Participants	3 subjects n=7 Participants	5 subjects n=5 Participants
Indication for Lung Transplant Other	2 subjects n=5 Participants	6 subjects n=7 Participants	8 subjects n=5 Participants
FVC, liters	2.02 liters n=5 Participants	1.89 liters n=7 Participants	1.95 liters n=5 Participants
6MWD, feet	1168 feet n=5 Participants	1120 feet n=7 Participants	1155 feet n=5 Participants
Smoking History No Smoking History/Never Smoked (past or present)	22 subjects n=5 Participants	21 subjects n=7 Participants	43 subjects n=5 Participants
Smoking History Past Smoking History: former smokers who quit	44 subjects n=5 Participants	49 subjects n=7 Participants	93 subjects n=5 Participants
Smoking History Current Smoking	0 subjects n=5 Participants	0 subjects n=7 Participants	0 subjects n=5 Participants
Daily Supplemental Oxygen Use Supplemental Oxygen use	53 subjects n=5 Participants	51 subjects n=7 Participants	104 subjects n=5 Participants
Daily Supplemental Oxygen Use No supplemental oxygen use	13 subjects n=5 Participants	19 subjects n=7 Participants	32 subjects n=5 Participants

PRIMARY outcome

Timeframe: over the course of 300 days after randomization

Population: Intention to treat analysis was conducted.

The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.

Outcome measures

Outcome measures
Measure	Placebo Group n=66 Participants Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)	Treatment Group n=70 Participants Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Incidence of CMV End Organ Disease	21 participants	1 participants

PRIMARY outcome

Timeframe: over the course of 300 days after randomization

Population: intention to treat analysis

CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)

Outcome measures

Outcome measures
Measure	Placebo Group n=66 Participants Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)	Treatment Group n=70 Participants Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Incidence of CMV Syndrome	13 participants	0 participants

SECONDARY outcome

Timeframe: over the course of 300 days post randomization

Population: intention to treat

Inclusive of CMV syndrome, disease, or infection not meeting primary end point.

Outcome measures

Outcome measures
Measure	Placebo Group n=66 Participants Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)	Treatment Group n=70 Participants Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Any CMV Infection	42 participants	7 participants

SECONDARY outcome

Timeframe: over the course of 300 days of randomization

Population: intention to treat

Outcome measures

Outcome measures
Measure	Placebo Group n=66 Participants Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)	Treatment Group n=70 Participants Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Biopsy Proven Acute Lung Rejection	22 participants	15 participants

SECONDARY outcome

Timeframe: over the course of 300 days after randomization

Population: intention to treat

non cmv opportunistic infections

Outcome measures

Outcome measures
Measure	Placebo Group n=66 Participants Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)	Treatment Group n=70 Participants Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Non-CMV Infection	35 participants	38 participants

SECONDARY outcome

Timeframe: over the course of 300 days after randomization

Population: Intention to treat

upon diagnosis of cmv disease, the number of CMV DNA copies/mL as measured by PCR

Outcome measures

Outcome measures
Measure	Placebo Group n=66 Participants Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)	Treatment Group n=70 Participants Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Severity of Viremia	110,000 CMV copies/mL	3,200 CMV copies/mL

SECONDARY outcome

Timeframe: over the course of 300 days post randomization

Population: intention to treat

UL97 genotyping was done on all positive samples for CMV DNA at 1000 copies/mL, with resistance defined by the presence of 1 or more mutations shown by marker transfer to confer phenotypic ganciclovir resistance

Outcome measures

Outcome measures
Measure	Placebo Group n=66 Participants Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)	Treatment Group n=70 Participants Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Ganciclovir Resistance	1 participants	2 participants

Adverse Events

Placebo Group

Serious events: 35 serious events

Other events: 64 other events

Deaths: 0 deaths

Treatment Group

Serious events: 38 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Scott M. Palmer, MD, MHS

Duke Clinical Research Institute

Phone: 919 684 0254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo Group n=66 participants at risk Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)	Treatment Group n=70 participants at risk Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
Infections and infestations SEPSIS	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Gastrointestinal disorders GASTROENTERITIS	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	4.3% 3/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Gastrointestinal disorders CLOSTRIDIUM DIFFICILE COLITIS	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	0.00% 0/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations CYTOMEGALOVIRUS COLITIS	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	0.00% 0/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations WOUND INFECTION	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	0.00% 0/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations PLEURAL EFFUSION	3.0% 2/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	0.00% 0/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations RESPIRATORY FAILURE	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
General disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
General disorders BRONCHOSTENOSIS	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations LUNG INFILTRATION	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Respiratory, thoracic and mediastinal disorders PULMONARY HAEMORRHAGE	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Immune system disorders LUNG TRANSPLANT REJECTION	7.6% 5/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	5.7% 4/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Immune system disorders TRANSPLANT REJECTION	4.5% 3/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	2.9% 2/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Gastrointestinal disorders GASTROINTESTINAL DISORDERS	10.6% 7/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	4.3% 3/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Gastrointestinal disorders ABDOMINAL PAIN	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Gastrointestinal disorders VOMITING	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Gastrointestinal disorders GASTROINTESTINAL DISORDER	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	0.00% 0/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Gastrointestinal disorders INTESTINAL OBSTRUCTION	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	0.00% 0/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Immune system disorders NEUTROPENIA	4.5% 3/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	12.9% 9/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Blood and lymphatic system disorders ANAEMIA	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	2.9% 2/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Gastrointestinal disorders PYREXIA	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	4.3% 3/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
General disorders MULTI-ORGAN FAILURE	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Cardiac disorders CARDIAC DISORDERS	3.0% 2/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	7.1% 5/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Cardiac disorders CARDIAC ARREST	1.5% 1/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	0.00% 0/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Vascular disorders ENCEPHALOPATHY	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	2.9% 2/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
General disorders HEADACHE	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Blood and lymphatic system disorders ISCHAEMIC STROKE	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations Opportunistic Infections, all organ systems	47.0% 31/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	45.7% 32/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations Opportunistic Infections, all organ systems, mild	16.7% 11/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	11.4% 8/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations Opportunistic Infections, all organ systems, moderate	25.8% 17/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	24.3% 17/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations Opportunistic Infections, all organ systems, severe	4.5% 3/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	10.0% 7/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Cardiac disorders Hospitalization	0.00% 0/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	1.4% 1/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).
Infections and infestations Death	4.5% 3/66 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).	5.7% 4/70 • Adverse events were collected from the first day posttransplant to the close of the study (day 390); however they were stratified by Phases (I and II) therefore SAEs are only reported for phase II subjects (ie only randomized subjects).