Trial Outcomes & Findings for Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant (NCT NCT00530218)

NCT ID: NCT00530218

Last Updated: 2017-12-02

Results Overview

This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 61 participants
• Primary outcome timeframe: From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant
• Results posted on: 2017-12-02

Participant Flow

Participant milestones

Measure	All Study Participants Patients undergo intervention with intravenous ganciclovir followed by oral ganciclovir, if cytomegalovirus reactivation is detected.
Overall Study STARTED	61
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	All Study Participants Patients undergo intervention with intravenous ganciclovir followed by oral ganciclovir, if cytomegalovirus reactivation is detected.
Overall Study CMV Not Detected	13
Overall Study Death	12

Baseline Characteristics

Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant

Baseline characteristics by cohort

Measure	All Study Participants n=61 Participants Blood Culture at Day 21 or later -or- PCR Test at Day 21 or later
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants

PRIMARY outcome

Timeframe: From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant

Population: Patients are treated with Intravenous Ganciclovir followed by Oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.

This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.

Outcome measures

Measure	CMV Reactivation Patients With GCV n=32 Participants CMV reactivation patients with intravenous Ganciclovir followed by oral Ganciclovir.
Number of Participants With Adverse Events Hemolysis	1 Participants
Number of Participants With Adverse Events Leukocytes	22 Participants
Number of Participants With Adverse Events Lymphopenia	2 Participants
Number of Participants With Adverse Events Hair Loss / Alopecia	4 Participants
Number of Participants With Adverse Events Pigmentation Changes	5 Participants
Number of Participants With Adverse Events Pruritus/Itching	3 Participants
Number of Participants With Adverse Events Rash/Desquamation	3 Participants
Number of Participants With Adverse Events Thrombosis/thrombus/embolism	1 Participants
Number of Participants With Adverse Events Haptoglobin	1 Participants
Number of Participants With Adverse Events Hemoglobin	31 Participants
Number of Participants With Adverse Events Neutrophils/granulocytes	12 Participants
Number of Participants With Adverse Events Platelets	26 Participants
Number of Participants With Adverse Events pRBCs	17 Participants
Number of Participants With Adverse Events aGVHD	21 Participants
Number of Participants With Adverse Events cGVHD	1 Participants
Number of Participants With Adverse Events Palpitations	1 Participants
Number of Participants With Adverse Events Supraventricular and nodal arrhythmia	19 Participants
Number of Participants With Adverse Events Cardiac General - Other	1 Participants
Number of Participants With Adverse Events Hypertension	13 Participants
Number of Participants With Adverse Events Hypotension	5 Participants
Number of Participants With Adverse Events Edema	8 Participants
Number of Participants With Adverse Events INR	1 Participants
Number of Participants With Adverse Events Fatigue	21 Participants
Number of Participants With Adverse Events Fever	10 Participants
Number of Participants With Adverse Events Insomnia	3 Participants
Number of Participants With Adverse Events Rigors/Chills	6 Participants
Number of Participants With Adverse Events Sweating	1 Participants
Number of Participants With Adverse Events Weight loss	3 Participants
Number of Participants With Adverse Events Bruising	2 Participants
Number of Participants With Adverse Events Skin - Other	3 Participants
Number of Participants With Adverse Events Dry Skin	5 Participants
Number of Participants With Adverse Events Flushing	4 Participants
Number of Participants With Adverse Events Rash/Desquamation w GVHD	19 Participants
Number of Participants With Adverse Events Wound Complication, Non-infection	1 Participants
Number of Participants With Adverse Events Cushingoid Appearance	15 Participants
Number of Participants With Adverse Events Endocrine - Other	2 Participants
Number of Participants With Adverse Events Thyroid Function, Low (Hypothyroidism)	1 Participants
Number of Participants With Adverse Events Anorexia	15 Participants
Number of Participants With Adverse Events Constipation	1 Participants
Number of Participants With Adverse Events Dehydration	16 Participants
Number of Participants With Adverse Events Diarrhea	4 Participants
Number of Participants With Adverse Events Diarrhea with GVHD	4 Participants
Number of Participants With Adverse Events Dry mouth/Salivary Gland (Xerostomia)	2 Participants
Number of Participants With Adverse Events Esophagitis	2 Participants
Number of Participants With Adverse Events Flatulence	4 Participants
Number of Participants With Adverse Events Gastritis	2 Participants
Number of Participants With Adverse Events Gastrointestinal - Other	6 Participants
Number of Participants With Adverse Events Heartburn/Dyspepsia	4 Participants
Number of Participants With Adverse Events Mucositis/Stomatitis	1 Participants
Number of Participants With Adverse Events Nausea	22 Participants
Number of Participants With Adverse Events Stomatitis/pharyngitis (Oral/Pharyngeal Mucositis)	16 Participants
Number of Participants With Adverse Events Taste Alteration (Dysgeusia)	5 Participants
Number of Participants With Adverse Events Vomiting	14 Participants
Number of Participants With Adverse Events Hematuria (in the absence of vaginal bleeding)	4 Participants
Number of Participants With Adverse Events Hemorrhage/bleeding w/ grade 3 or 4 thrombocytopni	2 Participants
Number of Participants With Adverse Events Hemorrhage/bleeding w/o grade 3 or 4 thrombocytope	2 Participants
Number of Participants With Adverse Events Hemorrhage, pulmonary/upper respiratory	1 Participants
Number of Participants With Adverse Events Hemorrhage/Bleeding - Other	1 Participants
Number of Participants With Adverse Events Petechiae/purpura	1 Participants
Number of Participants With Adverse Events Bilirubin with GVHD	5 Participants
Number of Participants With Adverse Events Febrile Neutropenia	1 Participants
Number of Participants With Adverse Events Infection - Other	1 Participants
Number of Participants With Adverse Events Infection w/ unknown ANC	3 Participants
Number of Participants With Adverse Events Infection - Bacterial	13 Participants
Number of Participants With Adverse Events Infection - Fungal	3 Participants
Number of Participants With Adverse Events Infection - Viral	8 Participants
Number of Participants With Adverse Events Lymphatics	1 Participants
Number of Participants With Adverse Events ALT, SGPT	31 Participants
Number of Participants With Adverse Events AST, SGOT	23 Participants
Number of Participants With Adverse Events Albumin, serum-low (hypoalbuminemia)	25 Participants
Number of Participants With Adverse Events Alkaline phosphatase	11 Participants
Number of Participants With Adverse Events Bilirubin (hyperbilirubinemia)	8 Participants
Number of Participants With Adverse Events CPK (creatine phosphokinase)	1 Participants
Number of Participants With Adverse Events Calcium, serum-high (hypercalcemia)	1 Participants
Number of Participants With Adverse Events Calcium, serum-low (hypocalcemia)	20 Participants
Number of Participants With Adverse Events Cholesterol, serum-high (hypercholesteremia)	23 Participants
Number of Participants With Adverse Events Creatinine	20 Participants
Number of Participants With Adverse Events Glucose, serum-high (hyperglycemia)	24 Participants
Number of Participants With Adverse Events Magnesium, serum-high (hypermagnesemia)	4 Participants
Number of Participants With Adverse Events Magnesium, serum-low (hypomagnesemia)	27 Participants
Number of Participants With Adverse Events Metabolic/Laboratory - Other	1 Participants
Number of Participants With Adverse Events Phosphate, serum-low (hypophosphatemia)	21 Participants
Number of Participants With Adverse Events Potassium, serum-high (hyperkalemia)	7 Participants
Number of Participants With Adverse Events Potassium, serum-low (hypokalemia)	16 Participants
Number of Participants With Adverse Events Proteinuria	1 Participants
Number of Participants With Adverse Events Sodium, serum-low (hyponatremia)	15 Participants
Number of Participants With Adverse Events Uric acid, serum-high (hyperuricemia)	5 Participants
Number of Participants With Adverse Events Muscle weakness, generalized or specific area	3 Participants
Number of Participants With Adverse Events Musculoskeletal/Soft Tissue - Other	2 Participants
Number of Participants With Adverse Events Myositis (inflammation/damage of muscle)	1 Participants
Number of Participants With Adverse Events Confusion	1 Participants
Number of Participants With Adverse Events Dizziness	5 Participants
Number of Participants With Adverse Events Memory Impairment	1 Participants
Number of Participants With Adverse Events Mood Alteration	11 Participants
Number of Participants With Adverse Events Neurology - Other	4 Participants
Number of Participants With Adverse Events Neuropathy: Motor	1 Participants
Number of Participants With Adverse Events Neuropathy: Sensory	3 Participants
Number of Participants With Adverse Events Speech Impairment	1 Participants
Number of Participants With Adverse Events Syncope	1 Participants
Number of Participants With Adverse Events Tremor	12 Participants
Number of Participants With Adverse Events Dry eye syndrome	2 Participants
Number of Participants With Adverse Events Ocular/Visual - Other	4 Participants
Number of Participants With Adverse Events Ophthalmoplegia/diplopia (double vision)	1 Participants
Number of Participants With Adverse Events Pain	25 Participants
Number of Participants With Adverse Events Adult Respiratory Distress Syndrome (ARDS)	2 Participants
Number of Participants With Adverse Events Cough	7 Participants
Number of Participants With Adverse Events Dyspnea (shortness of breath)	7 Participants
Number of Participants With Adverse Events Hypoxia	2 Participants
Number of Participants With Adverse Events Pleural effusion (non-malignant)	1 Participants
Number of Participants With Adverse Events Pneumonitis/pulmonary infiltrates	6 Participants
Number of Participants With Adverse Events Pulmonary/Upper Respiratory - Other	2 Participants
Number of Participants With Adverse Events Urinary frequency/urgency	1 Participants
Number of Participants With Adverse Events Urinary retention (including neurogenic bladder)	1 Participants

PRIMARY outcome

Timeframe: Twice Weekly after day 21 post-transplant

Outcome measures

Measure	CMV Reactivation Patients With GCV n=61 Participants CMV reactivation patients with intravenous Ganciclovir followed by oral Ganciclovir.
Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment CMV Reactivation	36 Participants
Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment No CMV Reactivation	25 Participants

PRIMARY outcome

Timeframe: From first ganciclovir positive test to the end of the 6th week GCV therapy

Population: Among the 36 patients with CMV reactivation, two patients are in-evaluable for compliance.

CMV reactivation patients completed 6-week GCV therapy.

Outcome measures

Measure	CMV Reactivation Patients With GCV n=34 Participants CMV reactivation patients with intravenous Ganciclovir followed by oral Ganciclovir.
Compliance Rate Among Patients With CMV Reactivation Compliance	26 participants
Compliance Rate Among Patients With CMV Reactivation No Compliance	8 participants

Adverse Events

Patients With CMV Reactivation Detected

Serious events: 0 serious events

Other events: 32 other events

Deaths: 19 deaths

Patients Without CMV Reactivation Detected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Patients With CMV Reactivation Detected n=32 participants at risk CMV Positive Blood Culture at Day 21 or later -or- CMV Positive PCR Test at Day 21 or later	Patients Without CMV Reactivation Detected No CMV Positive Blood Culture at Day 21 or later -and- No CMV Positive PCR Test at Day 21 or later
Blood and lymphatic system disorders Haptoglobin	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Hemoglobin	96.9% 31/32 • Number of events 31 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Hemolysis	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Leukocytes	68.8% 22/32 • Number of events 22 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Lymphopenia	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Neutrophils/granulocytes	37.5% 12/32 • Number of events 12 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Platelets	81.2% 26/32 • Number of events 26 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders pRBCs	53.1% 17/32 • Number of events 17 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Acute graft versus host disease	65.6% 21/32 • Number of events 21 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Chronic graft versus host disease	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Cardiac disorders Palpitations	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Cardiac disorders Supraventricular and nodal arrhythmia	59.4% 19/32 • Number of events 19 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Cardiac disorders Cardiac General - Other	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Cardiac disorders Hypertension	40.6% 13/32 • Number of events 13 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Cardiac disorders Hypotension	15.6% 5/32 • Number of events 5 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Cardiac disorders Edema	25.0% 8/32 • Number of events 8 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Cardiac disorders INR (International Normalized Ratio of prothrombin time)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
General disorders Fatigue (asthenia, lethargy, malaise)	65.6% 21/32 • Number of events 21 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
General disorders Fever	31.2% 10/32 • Number of events 10 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
General disorders Insomnia	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
General disorders Rigors/chills	18.8% 6/32 • Number of events 6 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
General disorders Sweating (diaphoresis)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
General disorders Weight loss	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Bruising	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Dry Skin	15.6% 5/32 • Number of events 5 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Flushing	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Pigmentation changes	15.6% 5/32 • Number of events 5 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Pruritus/itching	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Rash/desquamation	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Rash/desquamation with GVHD	59.4% 19/32 • Number of events 19 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Skin and subcutaneous tissue disorders Wound complication, non-infectious	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Endocrine disorders Cushingoid appearance	46.9% 15/32 • Number of events 15 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Endocrine disorders Endocrine - Other	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Endocrine disorders Thyroid function, low (hypothyroidism)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Anorexia	46.9% 15/32 • Number of events 15 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Constipation	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Dehydration	50.0% 16/32 • Number of events 16 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Diarrhea	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Diarrhea with GVHD	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Esophagitis	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Flatulence	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Gastrointestinal - Other	18.8% 6/32 • Number of events 6 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Heartburn/dyspepsia	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Nausea	68.8% 22/32 • Number of events 22 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	50.0% 16/32 • Number of events 16 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Taste alteration (dysgeusia)	15.6% 5/32 • Number of events 5 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Gastrointestinal disorders Vomiting	43.8% 14/32 • Number of events 14 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Investigations Hematuria (in the absence of vaginal bleeding)	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Investigations Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Investigations Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Investigations Hemorrhage, pulmonary/upper respiratory	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Investigations Hemorrhage/Bleeding - Other	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Investigations Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Investigations Bilirubin associated with graft versus host disease (GVHD)	15.6% 5/32 • Number of events 5 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Infections and infestations Febrile neutropenia	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Infections and infestations Infection - Other	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Investigations Infection with unknown ANC	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Infections and infestations Infection, Bacterial	40.6% 13/32 • Number of events 13 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Infections and infestations Infection, Fungal	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Infections and infestations Infection, Viral	25.0% 8/32 • Number of events 8 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Blood and lymphatic system disorders Lymphatics	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	96.9% 31/32 • Number of events 31 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	71.9% 23/32 • Number of events 23 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	78.1% 25/32 • Number of events 25 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Alkaline phosphatase	34.4% 11/32 • Number of events 11 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	25.0% 8/32 • Number of events 8 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders CPK (creatine phosphokinase)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	62.5% 20/32 • Number of events 20 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Cholesterol, serum-high (hypercholesteremia)	71.9% 23/32 • Number of events 23 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Creatinine	62.5% 20/32 • Number of events 20 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	75.0% 24/32 • Number of events 24 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	84.4% 27/32 • Number of events 27 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Metabolic/Laboratory - Other	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	65.6% 21/32 • Number of events 21 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	21.9% 7/32 • Number of events 7 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	50.0% 16/32 • Number of events 16 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Proteinuria	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	46.9% 15/32 • Number of events 15 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	15.6% 5/32 • Number of events 5 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Musculoskeletal and connective tissue disorders Myositis (inflammation/damage of muscle)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Confusion	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Dizziness	15.6% 5/32 • Number of events 5 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Memory impairment	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Mood alteration	34.4% 11/32 • Number of events 11 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Neurology - Other	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Neuropathy: motor	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Neuropathy: sensory	9.4% 3/32 • Number of events 3 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Speech impairment	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Syncope (fainting)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Nervous system disorders Tremor	37.5% 12/32 • Number of events 12 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Eye disorders Dry eye syndrome	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Eye disorders Ocular/Visual - Other	12.5% 4/32 • Number of events 4 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Eye disorders Ophthalmoplegia/diplopia (double vision)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
General disorders Pain	78.1% 25/32 • Number of events 25 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome (ARDS)	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Respiratory, thoracic and mediastinal disorders Cough	21.9% 7/32 • Number of events 7 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	21.9% 7/32 • Number of events 7 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	18.8% 6/32 • Number of events 6 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other	6.2% 2/32 • Number of events 2 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Renal and urinary disorders Urinary frequency/urgency	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
Vascular disorders Thrombosis/thrombus/embolism	3.1% 1/32 • Number of events 1 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.	— 0/0 • Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100. Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.

Additional Information

Ricardo Spielberger, MD

City of Hope National Medical Center

Phone: 626-359-8111

Email: RSpielberger@coh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place