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Trial record 25 of 101 for:    Valcyte

Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00466817
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : November 13, 2013
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Cytomegalovirus Infection
Interventions Other: Placebo
Drug: Valganciclovir
Enrollment 109
Recruitment Details  
Pre-assignment Details All 109 subjects started on valganciclovir. At the end of 6 weeks, subjects were randomized to valganciclovir or placebo. of the 109 subject that started, 12 dropped out before randomization and 1 subject was randomized but never received any blinded study drug.
Arm/Group Title Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Period Title: Overall Study
Started 49 47
Completed 44 43
Not Completed 5 4
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir Total
Hide Arm/Group Description

Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Total of all reporting groups
Overall Number of Baseline Participants 49 47 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 49 participants 47 participants 96 participants
19
(2 to 30)
14
(5 to 30)
15
(2 to 30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 47 participants 96 participants
Female
20
  40.8%
16
  34.0%
36
  37.5%
Male
29
  59.2%
31
  66.0%
60
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 47 participants 96 participants
49 47 96
1.Primary Outcome
Title Change in Best Ear Hearing Assessments at 6 Months.
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported
Arm/Group Title Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: participants
Worsened 3 5
No Change 37 36
One point improvement 3 2
2.Secondary Outcome
Title Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.
Hide Description Adverse events were assessed at each visit through month 7 of the study. No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event.
Time Frame baseline through 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo Valganciclovir: 24 Wks Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 49 47
Measure Type: Number
Unit of Measure: participants
Permanent discontinuation of study drug 0 0
Irreversible outcome from use of study drug 0 0
3.Secondary Outcome
Title Change in Best Ear Hearing Assessments at 12 Months.
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods
Arm/Group Title Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Weeks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 40 41
Measure Type: Number
Unit of Measure: participants
Improved hearing 2 2
No change - normal hearing 23 30
No change - same degree of hearing loss 10 6
Worsening hearing 5 3
4.Secondary Outcome
Title Change in Best Ear Hearing Assessments at 24 Months.
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods
Arm/Group Title Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 31 37
Measure Type: Number
Unit of Measure: participants
Improved hearing 2 2
No change - normal hearing 20 30
No change - same degree of hearing loss 7 2
Worsening hearing 2 3
5.Secondary Outcome
Title Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported
Arm/Group Title Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: ears
Improved or protected hearing 46 52
Same hearing loss or deterioration 38 30
6.Secondary Outcome
Title Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects that were randomized and had baseline and 12 month hearing exams were analyzed.
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 40 41
Measure Type: Number
Unit of Measure: ears
Improved or protected hearing 44 58
Same hearing loss or worsening 33 21
7.Secondary Outcome
Title Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 31 37
Measure Type: Number
Unit of Measure: ears
Improved or protected 37 54
Same hearing loss or worsened hearing 21 16
8.Secondary Outcome
Title Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported
Arm/Group Title Placebo: 6 Wks of Vlaganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: ears
No worsening of hearing 75 71
Worsening hearing 9 11
9.Secondary Outcome
Title Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 40 41
Measure Type: Number
Unit of Measure: ears
No worsening of hearing 67 73
Worsening hearing 10 6
10.Secondary Outcome
Title Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)
Hide Description Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.
Time Frame Between baseline and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 31 37
Measure Type: Number
Unit of Measure: ears
No worsening of hearing 53 62
Worsening hearing 5 8
11.Secondary Outcome
Title Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).
Hide Description Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cogonitive skills score for a child (age adjusted) is 100 with standard deviation of 15.
Time Frame 12 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 12 month Bayleys exam Cognitive Composite Score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 45 43
Mean (Standard Error)
Unit of Measure: units on a scale
76.5  (3.4) 84.2  (3.0)
12.Secondary Outcome
Title Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).
Hide Description Receptive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
Time Frame 12 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 12 month Bayleys exam Receptive Communications scorewere analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 43 41
Mean (Standard Error)
Unit of Measure: units on a scale
5.8  (0.5) 6.8  (0.6)
13.Secondary Outcome
Title Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).
Hide Description Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
Time Frame 12 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 12 month Bayleys exam expressinve Communications scaled score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 44 41
Mean (Standard Error)
Unit of Measure: units on a scale
6.1  (0.5) 7.3  (0.5)
14.Secondary Outcome
Title Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).
Hide Description Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.
Time Frame 12 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 12 month Bayleys exam language composite score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 43 41
Mean (Standard Error)
Unit of Measure: units on a scale
74.8  (3.2) 82.9  (2.9)
15.Secondary Outcome
Title Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).
Hide Description Fine Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
Time Frame 12 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 12 month Bayleys exam fine motor score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 44 41
Mean (Standard Error)
Unit of Measure: units on a scale
5.5  (0.6) 6.5  (0.6)
16.Secondary Outcome
Title Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).
Hide Description Gross Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
Time Frame 12 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 12 month Bayleys exam gross motor score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 44 42
Mean (Standard Error)
Unit of Measure: units on a scale
4.9  (0.6) 5.6  (0.5)
17.Secondary Outcome
Title Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).
Hide Description Motor Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.
Time Frame 12 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 12 month Bayleys exam motor composite score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 44 42
Mean (Standard Error)
Unit of Measure: units on a scale
70.0  (3.7) 76.5  (3.1)
18.Secondary Outcome
Title Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).
Hide Description Receptive Communication Scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
Time Frame 24 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 24 month Bayleys exam receptive communication scaled were analyzed
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 41 41
Mean (Standard Error)
Unit of Measure: units on a scale
4.9  (0.5) 6.4  (0.6)
19.Secondary Outcome
Title Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).
Hide Description Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores are between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cognitive skills score for a child (age adjusted) is 100 with standard deviation of 15.
Time Frame 24 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 24 month Bayleys exam cognitive composite score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
74.9  (2.8) 79.6  (2.9)
20.Secondary Outcome
Title Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).
Hide Description Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.
Time Frame 24 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 24 month Bayleys exam expressive communications scaled score were analyzed
Arm/Group Title Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 41 41
Mean (Standard Error)
Unit of Measure: units on a scale
5.3  (0.6) 6.5  (0.5)
21.Secondary Outcome
Title Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).
Hide Description Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.
Time Frame 24 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 24 month Bayleys exam language composite score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Vlaganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 41 41
Mean (Standard Error)
Unit of Measure: units on a scale
71.2  (3.3) 79.5  (3.1)
22.Secondary Outcome
Title Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).
Hide Description Fine motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
Time Frame 24 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 24 month Bayleys exam fine motor were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 40 42
Mean (Standard Error)
Unit of Measure: units on a scale
6.0  (0.7) 6.9  (0.6)
23.Secondary Outcome
Title Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).
Hide Description Gross motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.
Time Frame 24 Months after enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 24 month Bayleys exam gross motor score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 40 42
Mean (Standard Error)
Unit of Measure: units on a scale
4.9  (0.6) 6.1  (0.5)
24.Secondary Outcome
Title Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).
Hide Description Motor composite score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.
Time Frame 24 Months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
only subjects that were randomized and had the 24 month Bayleys exam motor composite score were analyzed
Arm/Group Title Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo Valganciclovir: 24 Wks of Valganciclovir
Hide Arm/Group Description:

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Overall Number of Participants Analyzed 40 41
Mean (Standard Error)
Unit of Measure: units on a scale
71.8  (3.7) 80.1  (3.3)
Time Frame Adverse events were reported between baseline and 7 months
Adverse Event Reporting Description There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
 
Arm/Group Title Non Randomized Active Placebo After 6 Weeks of Valganciclovir
Hide Arm/Group Description 6 weeks of open label valganciclovir only 6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir 6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo
All-Cause Mortality
Non Randomized Active Placebo After 6 Weeks of Valganciclovir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Non Randomized Active Placebo After 6 Weeks of Valganciclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      11/47 (23.40%)      19/49 (38.78%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 2/49 (4.08%)  2
Neutropenia * 1  0/13 (0.00%)  0 3/47 (6.38%)  3 8/49 (16.33%)  9
Congenital, familial and genetic disorders       
Ankyloglossia congenital * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea haemorrhagic * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Gastrooesophageal reflux disease * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Vomoting * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
General disorders       
Pyrexia * 1  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Infections and infestations       
Bronchiolitis * 1  0/13 (0.00%)  0 2/47 (4.26%)  2 1/49 (2.04%)  1
Gastroenteritis viral * 1  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Otitis medial * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Pneumonia * 1  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Respiratory syncytial virus bronchiolitis * 1  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Respiratory syncytial virus infection * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 3/49 (6.12%)  3
Respiratory tract infection viral * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Urinary tract infection * 1  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Injury, poisoning and procedural complications       
Head injury * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Failure to thrive * 1  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Feeding disorder neonatal * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Respiratory distress * 1  1/13 (7.69%)  1 0/47 (0.00%)  0 0/49 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non Randomized Active Placebo After 6 Weeks of Valganciclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/13 (23.08%)      45/47 (95.74%)      47/49 (95.92%)    
Blood and lymphatic system disorders       
Anaemia * 1  2/13 (15.38%)  2 5/47 (10.64%)  6 9/49 (18.37%)  13
Neutropenia * 2  0/13 (0.00%)  0 11/47 (23.40%)  15 14/49 (28.57%)  33
Neutropenia Neonatal * 2  0/13 (0.00%)  0 1/47 (2.13%)  2 0/49 (0.00%)  0
Red blood cell abnormality * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Splenomegaly * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 2/49 (4.08%)  2
Thrombocytopenia * 2  0/13 (0.00%)  0 1/47 (2.13%)  2 1/49 (2.04%)  1
Thrombocytosis * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
White blood cell disorder * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Cardiac disorders       
Cyanosis * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Ear and labyrinth disorders       
Hearing impaired * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Middle ear effusion * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Otorrhoea * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Sudden hearing loss * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Endocrine disorders       
Hypothyroidism * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Eye disorders       
Astigmatism * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Blindness * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Conjunctival irritation * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Conjunctivitis * 2  0/13 (0.00%)  0 4/47 (8.51%)  4 4/49 (8.16%)  5
Dacryostenosis acquired * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Eye discharge * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 1/49 (2.04%)  1
Eye movement disorder * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Lacrimal disorder * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Photalgia * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Strabismus * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 3/49 (6.12%)  3
Swollen tear duct * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Gastrointestinal disorders       
Abdominal discomfort * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Anal fistula * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Constipation * 2  0/13 (0.00%)  0 7/47 (14.89%)  8 4/49 (8.16%)  4
Diarrhoea * 2  0/13 (0.00%)  0 9/47 (19.15%)  9 13/49 (26.53%)  23
Dysphagia * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Enteritis * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Flatulence * 2  0/13 (0.00%)  0 5/47 (10.64%)  6 8/49 (16.33%)  8
Gastrooesophageal reflux disease * 2  1/13 (7.69%)  1 5/47 (10.64%)  6 10/49 (20.41%)  11
Gingival pain * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Infantile colic * 2  0/13 (0.00%)  0 5/47 (10.64%)  5 3/49 (6.12%)  3
Infantile spitting up * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Melaena * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Mouth ulceration * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Oral pain * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 2/49 (4.08%)  2
Reflux gastritis * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Umbilical hernia * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Vomiting * 2  1/13 (7.69%)  1 9/47 (19.15%)  14 6/49 (12.24%)  12
General disorders       
Developmental delay * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 2/49 (4.08%)  2
Discomfort * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Feeling jittery * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Fever neonatal * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Irritability * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 3/49 (6.12%)  4
Irritability postvaccinal * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 0/49 (0.00%)  0
Pyrexia * 2  0/13 (0.00%)  0 3/47 (6.38%)  4 8/49 (16.33%)  10
Hepatobiliary disorders       
Cholestasis * 2  1/13 (7.69%)  1 0/47 (0.00%)  0 0/49 (0.00%)  0
Hepatomegaly * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Hyperbilirubinaemia * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Immune system disorders       
Anaphylactic reaction * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Milk allergy * 2  0/13 (0.00%)  0 1/47 (2.13%)  3 0/49 (0.00%)  0
Infections and infestations       
Adenoviral upper respiratory infection * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Bronchiolitis * 2  0/13 (0.00%)  0 1/47 (2.13%)  2 3/49 (6.12%)  3
Candida nappy rash * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 1/49 (2.04%)  1
Bronchitis * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 1/49 (2.04%)  1
Candidiasis * 2  0/13 (0.00%)  0 3/47 (6.38%)  3 2/49 (4.08%)  2
Cellulitis * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Croup infectious * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Ear infection * 2  0/13 (0.00%)  0 3/47 (6.38%)  3 2/49 (4.08%)  2
Gastroenteritis * 2  0/13 (0.00%)  0 5/47 (10.64%)  5 3/49 (6.12%)  3
Gastroenteritis viral * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 2/49 (4.08%)  2
Genital candidiasis * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Lower respiratory tract infection * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Nasopharyngitis * 2  0/13 (0.00%)  0 1/47 (2.13%)  2 0/49 (0.00%)  0
Oral candidiasis * 2  0/13 (0.00%)  0 7/47 (14.89%)  9 6/49 (12.24%)  6
Oral fungal infection * 2  1/13 (7.69%)  1 0/47 (0.00%)  0 2/49 (4.08%)  2
Otitis media * 2  0/13 (0.00%)  0 11/47 (23.40%)  15 12/49 (24.49%)  23
Otitis media acute * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Otitis media bacterial * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Pneumonia * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Recurring skin boils * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Respiratory syncytial virus bronchiolitis * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Respiratory syncytial virus infection * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 0/49 (0.00%)  0
Respiratory tract infection * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Rhinitis * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Sinusitis * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Skin candida * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Upper respiratory tract infection * 2  0/13 (0.00%)  0 15/47 (31.91%)  24 14/49 (28.57%)  19
Urinary tract infection * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Viral infection * 2  0/13 (0.00%)  0 3/47 (6.38%)  5 0/49 (0.00%)  0
Viral rash * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Viral upper respiratory tract infection * 2  0/13 (0.00%)  0 1/47 (2.13%)  2 1/49 (2.04%)  2
Injury, poisoning and procedural complications       
Feeding tube complication * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Scratch * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Investigations       
Alanine aminotransferase increased * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Aspartate aminotransferase increased * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 2/49 (4.08%)  2
Bacteria stool identified * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Blood bilirubin increased * 2  0/13 (0.00%)  0 1/47 (2.13%)  2 0/49 (0.00%)  0
Blood calcium increased * 2  0/13 (0.00%)  0 2/47 (4.26%)  3 0/49 (0.00%)  0
Blood potassium increased * 2  0/13 (0.00%)  0 2/47 (4.26%)  4 1/49 (2.04%)  1
Body temperature increased * 2  0/13 (0.00%)  0 2/47 (4.26%)  4 2/49 (4.08%)  2
Carbon dioxide decreased * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Cardiac murmur * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Eosinophil count increased * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Haemoglobin abnormal * 2  0/13 (0.00%)  0 1/47 (2.13%)  3 1/49 (2.04%)  1
Haemoglobin decreased * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Head lag * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 3/49 (6.12%)  3
Liver function test abnormal * 2  1/13 (7.69%)  1 6/47 (12.77%)  6 4/49 (8.16%)  7
Neutrophil count abnormal * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Neutrophil count decreased * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 2/49 (4.08%)  2
Nuclear magnetic resonance imaging abnormal * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Occult blood positive * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 3/49 (6.12%)  3
Stool analysis abnormal * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Transaminases increased * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Weight decreased * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
White blood cell count decreased * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
White blood cell count increased * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Metabolism and nutrition disorders       
Decreased appetite * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Dehydration * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Failure to thrive * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 2/49 (4.08%)  2
Fluid intake reduced * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 1/49 (2.04%)  1
Hyperkalaemia * 2  0/13 (0.00%)  0 2/47 (4.26%)  3 0/49 (0.00%)  0
Iron deficiency * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders       
Head deformity * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Ligament laxity * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Loose body in joint * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Temporomandibular joint syndrome * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Nervous system disorders       
Convulsion * 2  0/13 (0.00%)  0 1/47 (2.13%)  2 0/49 (0.00%)  0
Crying * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Dystonia * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Hypersomnia * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Hypertonia * 2  0/13 (0.00%)  0 4/47 (8.51%)  4 4/49 (8.16%)  4
Infantile spasms * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Muscle spasticity * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Partial seizures * 2  0/13 (0.00%)  0 1/47 (2.13%)  2 3/49 (6.12%)  3
Poor quality sleep * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Reflexes abnormal * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Sleep phase rhythm disturbance * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Hypotonia * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 4/49 (8.16%)  4
Renal and urinary disorders       
Hydronephrosis * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Reproductive system and breast disorders       
Genital erythema * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Penile pain * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders       
Allergic respiratory disease * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Allergic respiratory symptom * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Cough * 2  0/13 (0.00%)  0 7/47 (14.89%)  8 5/49 (10.20%)  5
Epistaxis * 2  1/13 (7.69%)  1 0/47 (0.00%)  0 0/49 (0.00%)  0
Nasal congestion * 2  1/13 (7.69%)  1 4/47 (8.51%)  4 6/49 (12.24%)  8
Nasopharyngeal reflux * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Pneumonitis * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Respiratory tract congestion * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Rhinorrhoea * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Sleep apnoea syndrome * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  2
Sneezing * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Stridor * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Tachypnoea * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Upper airway obstruction * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Upper respiratory tract congestion * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 3/49 (6.12%)  3
Wheezing * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Skin and subcutaneous tissue disorders       
Acne * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Acne infantile * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  1
Dermatitis * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 2/49 (4.08%)  2
Dermatitis atopic * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Dermatitis contact * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  3
Dermatitis diaper * 2  0/13 (0.00%)  0 11/47 (23.40%)  11 4/49 (8.16%)  5
Dry skin * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 0/49 (0.00%)  0
Ecchymosis * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Eczema * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 2/49 (4.08%)  2
Eczema infantile * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 0/49 (0.00%)  0
Erythema toxicum neonatorum * 2  0/13 (0.00%)  0 2/47 (4.26%)  3 0/49 (0.00%)  0
Heat rash * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Petechiae * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  2
Rash * 2  0/13 (0.00%)  0 6/47 (12.77%)  7 11/49 (22.45%)  13
Rash macular * 2  0/13 (0.00%)  0 1/47 (2.13%)  1 1/49 (2.04%)  2
Rash pruritic * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
Seborrhoeic dermatitis * 2  0/13 (0.00%)  0 3/47 (6.38%)  3 1/49 (2.04%)  1
Surgical and medical procedures       
Circumcision * 2  0/13 (0.00%)  0 2/47 (4.26%)  2 1/49 (2.04%)  1
Oxygen supplementation * 2  0/13 (0.00%)  0 0/47 (0.00%)  0 1/49 (2.04%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
2
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Kimberlin, MD
Organization: University of Alabama in Birmingham
Phone: 205-934-2424
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00466817     History of Changes
Other Study ID Numbers: 06-0046
CASG 112
First Submitted: April 26, 2007
First Posted: April 27, 2007
Results First Submitted: August 29, 2013
Results First Posted: November 13, 2013
Last Update Posted: August 26, 2015