NCT00530218 · OUTCOME

Number of Participants With Adverse Events

Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant · Source last updated 2017-12-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant

What was measured

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

Analysis 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.

Groups in this outcome

CMV Reactivation Patients With GCV

CMV reactivation patients with intravenous Ganciclovir followed by oral Ganciclovir.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
CMV Reactivation Patients With GCV	32

Reported measurements

Haptoglobin

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Hemoglobin

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	31	Not reported	Not reported	Not reported	Not reported

Hemolysis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Leukocytes

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	22	Not reported	Not reported	Not reported	Not reported

Lymphopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Neutrophils/granulocytes

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	12	Not reported	Not reported	Not reported	Not reported

Platelets

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	26	Not reported	Not reported	Not reported	Not reported

pRBCs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	17	Not reported	Not reported	Not reported	Not reported

aGVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	21	Not reported	Not reported	Not reported	Not reported

cGVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Palpitations

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Supraventricular and nodal arrhythmia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	19	Not reported	Not reported	Not reported	Not reported

Cardiac General - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	13	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	5	Not reported	Not reported	Not reported	Not reported

Edema

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	8	Not reported	Not reported	Not reported	Not reported

INR

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	21	Not reported	Not reported	Not reported	Not reported

Fever

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	10	Not reported	Not reported	Not reported	Not reported

Insomnia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Rigors/Chills

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	6	Not reported	Not reported	Not reported	Not reported

Sweating

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Weight loss

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Bruising

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Skin - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Dry Skin

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	5	Not reported	Not reported	Not reported	Not reported

Flushing

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Hair Loss / Alopecia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Pigmentation Changes

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	5	Not reported	Not reported	Not reported	Not reported

Pruritus/Itching

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Rash/Desquamation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Rash/Desquamation w GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	19	Not reported	Not reported	Not reported	Not reported

Wound Complication, Non-infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Cushingoid Appearance

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	15	Not reported	Not reported	Not reported	Not reported

Endocrine - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Thyroid Function, Low (Hypothyroidism)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	15	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	16	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Diarrhea with GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Dry mouth/Salivary Gland (Xerostomia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Esophagitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Flatulence

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Gastritis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Gastrointestinal - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	6	Not reported	Not reported	Not reported	Not reported

Heartburn/Dyspepsia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Mucositis/Stomatitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	22	Not reported	Not reported	Not reported	Not reported

Stomatitis/pharyngitis (Oral/Pharyngeal Mucositis)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	16	Not reported	Not reported	Not reported	Not reported

Taste Alteration (Dysgeusia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	5	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	14	Not reported	Not reported	Not reported	Not reported

Hematuria (in the absence of vaginal bleeding)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Hemorrhage/bleeding w/ grade 3 or 4 thrombocytopni

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Hemorrhage/bleeding w/o grade 3 or 4 thrombocytope

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Hemorrhage, pulmonary/upper respiratory

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Hemorrhage/Bleeding - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Petechiae/purpura

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Bilirubin with GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	5	Not reported	Not reported	Not reported	Not reported

Febrile Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Infection - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Infection w/ unknown ANC

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Infection - Bacterial

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	13	Not reported	Not reported	Not reported	Not reported

Infection - Fungal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Infection - Viral

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	8	Not reported	Not reported	Not reported	Not reported

Lymphatics

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

ALT, SGPT

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	31	Not reported	Not reported	Not reported	Not reported

AST, SGOT

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	23	Not reported	Not reported	Not reported	Not reported

Albumin, serum-low (hypoalbuminemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	25	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	11	Not reported	Not reported	Not reported	Not reported

Bilirubin (hyperbilirubinemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	8	Not reported	Not reported	Not reported	Not reported

CPK (creatine phosphokinase)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Calcium, serum-high (hypercalcemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Calcium, serum-low (hypocalcemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	20	Not reported	Not reported	Not reported	Not reported

Cholesterol, serum-high (hypercholesteremia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	23	Not reported	Not reported	Not reported	Not reported

Creatinine

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	20	Not reported	Not reported	Not reported	Not reported

Glucose, serum-high (hyperglycemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	24	Not reported	Not reported	Not reported	Not reported

Magnesium, serum-high (hypermagnesemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Magnesium, serum-low (hypomagnesemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	27	Not reported	Not reported	Not reported	Not reported

Metabolic/Laboratory - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Phosphate, serum-low (hypophosphatemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	21	Not reported	Not reported	Not reported	Not reported

Potassium, serum-high (hyperkalemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	7	Not reported	Not reported	Not reported	Not reported

Potassium, serum-low (hypokalemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	16	Not reported	Not reported	Not reported	Not reported

Proteinuria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Sodium, serum-low (hyponatremia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	15	Not reported	Not reported	Not reported	Not reported

Uric acid, serum-high (hyperuricemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	5	Not reported	Not reported	Not reported	Not reported

Muscle weakness, generalized or specific area

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Musculoskeletal/Soft Tissue - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Myositis (inflammation/damage of muscle)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Confusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Dizziness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	5	Not reported	Not reported	Not reported	Not reported

Memory Impairment

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Mood Alteration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	11	Not reported	Not reported	Not reported	Not reported

Neurology - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Neuropathy: Motor

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Neuropathy: Sensory

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	3	Not reported	Not reported	Not reported	Not reported

Speech Impairment

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Syncope

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Tremor

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	12	Not reported	Not reported	Not reported	Not reported

Dry eye syndrome

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Ocular/Visual - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	4	Not reported	Not reported	Not reported	Not reported

Ophthalmoplegia/diplopia (double vision)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	25	Not reported	Not reported	Not reported	Not reported

Adult Respiratory Distress Syndrome (ARDS)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Cough

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	7	Not reported	Not reported	Not reported	Not reported

Dyspnea (shortness of breath)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	7	Not reported	Not reported	Not reported	Not reported

Hypoxia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Pleural effusion (non-malignant)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Pneumonitis/pulmonary infiltrates

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	6	Not reported	Not reported	Not reported	Not reported

Pulmonary/Upper Respiratory - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	2	Not reported	Not reported	Not reported	Not reported

Urinary frequency/urgency

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Urinary retention (including neurogenic bladder)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Thrombosis/thrombus/embolism

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CMV Reactivation Patients With GCV	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
title
Haptoglobin
categories
measurements
group Id
OG000
value
31
title
Hemoglobin
categories
measurements
group Id
OG000
value
1
title
Hemolysis
categories
measurements
group Id
OG000
value
22
title
Leukocytes
categories
measurements
group Id
OG000
value
2
title
Lymphopenia
categories
measurements
group Id
OG000
value
12
title
Neutrophils/granulocytes
categories
measurements
group Id
OG000
value
26
title
Platelets
categories
measurements
group Id
OG000
value
17
title
pRBCs
categories
measurements
group Id
OG000
value
21
title
aGVHD
categories
measurements
group Id
OG000
value
1
title
cGVHD
categories
measurements
group Id
OG000
value
1
title
Palpitations
categories
measurements
group Id
OG000
value
19
title
Supraventricular and nodal arrhythmia

denoms

counts
group Id
OG000
value
32
units
Participants

description

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

groups

description
CMV reactivation patients with intravenous Ganciclovir followed by oral Ganciclovir.
id
OG000
title
CMV Reactivation Patients With GCV

param Type

COUNT_OF_PARTICIPANTS

population Description

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.

reporting Status

POSTED

time Frame

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

title

Number of Participants With Adverse Events

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice