Trial Outcomes & Findings for Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants (NCT NCT03107871)
NCT ID: NCT03107871
Last Updated: 2026-08-27
Results Overview
Baseline hearing thresholds were summarized descriptively using the average minimum response levels (MRLs) at 2 kHz and 4 kHz for each ear. Lower values indicate better hearing sensitivity.
TERMINATED
PHASE2
10 participants
Baseline assessment
2026-08-27
Participant Flow
Recruitment occurred through ENT clinics, pediatric referrals, and Department of Health referrals across participating sites. The study was terminated early by NIDCD because of slow enrollment after 10 participants were randomized. Although follow-up data were collected for several participants, target enrollment was not achieved and the prespecified efficacy analyses could not be performed.
No significant events occurred.
Participant milestones
| Measure |
Valganciclovir 16 mg/kg
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
Randomization
|
6
|
4
|
|
Overall Study
Baseline Hearing Outcomes
|
6
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Valganciclovir 16 mg/kg
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
Overall Study
Non-compliance
|
1
|
0
|
Baseline Characteristics
Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants
Baseline characteristics by cohort
| Measure |
Valganciclovir 16 mg/kg
n=6 Participants
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
n=4 Participants
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
10 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Age, Continuous
|
0.33 years
n=31 Participants
|
0.47 years
n=49 Participants
|
0.38 years
n=80 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
9 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=31 Participants
|
4 participants
n=49 Participants
|
10 participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Baseline assessmentPopulation: All randomized participants with baseline hearing assessments were included (6 valganciclovir, 4 placebo).
Baseline hearing thresholds were summarized descriptively using the average minimum response levels (MRLs) at 2 kHz and 4 kHz for each ear. Lower values indicate better hearing sensitivity.
Outcome measures
| Measure |
Valganciclovir 16mg/kg
n=6 Participants
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
n=4 Participants
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
Baseline Total Ear Hearing Thresholds
|
53.59 decibels (dB)
Standard Deviation 15.93
|
53.59 decibels (dB)
Standard Deviation 15.93
|
SECONDARY outcome
Timeframe: Baseline assessmentPopulation: All randomized participants with baseline best-ear hearing assessments were included (6 valganciclovir, 4 placebo).
Baseline best-ear hearing thresholds were summarized descriptively using the average minimum response levels (MRLs) at 2 kHz and 4 kHz. Lower values indicate better hearing sensitivity.
Outcome measures
| Measure |
Valganciclovir 16mg/kg
n=6 Participants
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
n=4 Participants
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
Baseline Best-Ear Hearing Thresholds (2 kHz and 4 kHz)
|
53.59 decibels (dB)
Standard Deviation 15.93
|
53.59 decibels (dB)
Standard Deviation 15.93
|
SECONDARY outcome
Timeframe: 20 months of agePopulation: Ten participants were randomized (6 valganciclovir, 4 placebo). Because the study was terminated early by NIDCD due to slow enrollment, the target sample size was not achieved and the planned inferential efficacy analysis was not performed. The reported values are descriptive summaries of available participant data only.
The MacArthur-Bates Communicative Development Inventories (CDI) Words Produced subscale is a parent-reported measure of expressive language development. Percentile scores range from 0 to 100, with higher percentile scores indicating better expressive language performance.
Outcome measures
| Measure |
Valganciclovir 16mg/kg
n=6 Participants
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
n=4 Participants
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
MacArthur-Bates Communicative Development Inventories (CDI): Words Produced Percentile Score
|
40.63 percentile
Standard Deviation 5
|
57.5 percentile
Standard Deviation 5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 and 20 months of age assessmentsParticipants were classified according to whether their MacArthur-Bates Communicative Development Inventories (CDI) Words Produced percentile score was below the 10th percentile. Scores below the 10th percentile indicate increased risk for expressive language delay. The study was terminated early because of slow enrollment; therefore, the prespecified efficacy analyses were not performed, and only descriptive summaries of available data are reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 20 months of agePopulation: Ten participants were randomized (6 valganciclovir, 4 placebo). Because the study was terminated early by NIDCD due to slow enrollment, the target sample size was not achieved and the prespecified inferential efficacy analyses were not performed. The reported values are descriptive summaries of available participant data only.
The MacArthur-Bates Communicative Development Inventories (CDI) Words and Sentences subscales assess expressive language development. This outcome summarizes the Complexity, Word Forms, and Mean Length of Utterance percentile scores. Percentile scores range from 0 to 100, with higher scores indicating better expressive language performance.
Outcome measures
| Measure |
Valganciclovir 16mg/kg
n=6 Participants
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
n=4 Participants
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
MacArthur-Bates CDI: Words and Sentences Subscale Percentiles
Complexity
|
40.0 percentile (0-100)
Interval 40.0 to 40.0
|
35.0 percentile (0-100)
Interval 35.0 to 35.0
|
|
MacArthur-Bates CDI: Words and Sentences Subscale Percentiles
Word Forms
|
45.5 percentile (0-100)
Interval 45.5 to 45.5
|
38.7 percentile (0-100)
Interval 38.7 to 38.7
|
|
MacArthur-Bates CDI: Words and Sentences Subscale Percentiles
Mean Length of Utterance
|
42.1 percentile (0-100)
Interval 42.1 to 42.1
|
37.9 percentile (0-100)
Interval 37.9 to 37.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments performed at 14 and 20 months of ageThe LittlEARS Auditory Questionnaire is a parent-reported measure of auditory development in young children. Raw scores range from 0 to 35, with higher scores indicating better auditory development. Normative values vary by age. Because the study was terminated early by the National Institute on Deafness and Other Communication Disorders (NIDCD) due to slow enrollment, the target sample size was not achieved and the prespecified inferential efficacy analyses were not performed. Only descriptive summaries of available participant data are reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 20 months of agePopulation: Ten participants were randomized (6 valganciclovir, 4 placebo). Because the study was terminated early by NIDCD due to slow enrollment, the target sample size was not achieved and the prespecified inferential efficacy analyses were not performed. No ASQ-3 outcome data were available for reporting.
The Ages and Stages Questionnaire, Third Edition (ASQ-3) is a parent-completed developmental screening instrument that evaluates five developmental domains: Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social. Each domain is scored separately; higher scores indicate better developmental performance within that domain. Because the study was terminated early by the National Institute on Deafness and Other Communication Disorders (NIDCD) due to slow enrollment, the target sample size was not achieved and the prespecified inferential efficacy analyses were not performed. No ASQ-3 outcome data are reported.
Outcome measures
| Measure |
Valganciclovir 16mg/kg
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
Developmental Domain Endpoints
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From week 2 to month 6 post-randomizationPharmacokinetic (PK) blood samples were collected between Week 2 and Month 6 after randomization to characterize valganciclovir exposure. Because the study was terminated early by the National Institute on Deafness and Other Communication Disorders (NIDCD) due to slow enrollment, the planned PK assays were not completed before study closure. Therefore, no pharmacokinetic results are available for reporting.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 7 post-randomizationPopulation: Ten participants were randomized (6 valganciclovir, 4 placebo). Viral load testing was planned but was not completed before study closure. Therefore, no viral load results are available for reporting.
Viral resistance testing was planned to evaluate the development of cytomegalovirus (CMV) resistance mutations following valganciclovir treatment. Because the study was terminated early by the National Institute on Deafness and Other Communication Disorders (NIDCD) due to slow enrollment, the planned viral resistance assays were not completed before study closure. Therefore, no viral resistance results are available for reporting.
Outcome measures
| Measure |
Valganciclovir 16mg/kg
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
Number of Participants With Viral Resistance Results
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline, Month 3, and Month 7 post-randomizationPopulation: Ten participants were randomized (6 valganciclovir, 4 placebo). Viral resistance testing was planned but was not completed before study closure. Therefore, no viral resistance results are available for reporting.
Cytomegalovirus (CMV) viral load testing was planned at baseline, Month 3, and Month 7 after randomization to assess CMV viral burden during and after treatment. Because the study was terminated early by the National Institute on Deafness and Other Communication Disorders (NIDCD) due to slow enrollment, the planned viral load assays were not completed before study closure. Therefore, no viral load results are available for reporting.
Outcome measures
| Measure |
Valganciclovir 16mg/kg
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
Viral Load
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 20 months of age (planned assessment)Population: Ten participants were randomized (6 valganciclovir, 4 placebo). Because the study was terminated early by NIDCD due to slow enrollment, the target sample size was not achieved and the prespecified inferential efficacy analyses were not performed. No analyzable LittlEARS outcome data were available for this endpoint.
The LittlEARS Auditory Questionnaire is a parent-reported measure of auditory development in young children. Raw scores range from 0 to 35, with higher scores indicating better auditory development. Because the study was terminated early by the National Institute on Deafness and Other Communication Disorders (NIDCD) due to slow enrollment, the target sample size was not achieved and the prespecified inferential efficacy analyses were not performed. No analyzable LittlEARS outcome data were available for reporting.
Outcome measures
| Measure |
Valganciclovir 16mg/kg
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
LittlEARS Auditory Questionnaire Score
|
0 participants
|
0 participants
|
Adverse Events
Valganciclovir 16 mg/kg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Valganciclovir 16 mg/kg
n=6 participants at risk
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Valganciclovir: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
|
Placebo
n=4 participants at risk
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Simple Syrup: Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
|
|---|---|---|
|
General disorders
Constipation
|
0.00%
0/6 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
25.0%
1/4 • Number of events 1 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
|
General disorders
Petechiae
|
0.00%
0/6 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
25.0%
1/4 • Number of events 1 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
|
General disorders
Neutropenia
|
50.0%
3/6 • Number of events 4 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
0.00%
0/4 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
|
Immune system disorders
Vomiting
|
16.7%
1/6 • Number of events 2 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
25.0%
1/4 • Number of events 2 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
|
General disorders
Poor Sleep
|
0.00%
0/6 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
25.0%
1/4 • Number of events 1 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
|
General disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
25.0%
1/4 • Number of events 2 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
|
General disorders
Viral Illness
|
16.7%
1/6 • Number of events 2 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
0.00%
0/3 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
|
Ear and labyrinth disorders
Otitis Media
|
33.3%
2/6 • Number of events 4 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
0.00%
0/4 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
|
General disorders
Bruise
|
0.00%
0/6 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
25.0%
1/4 • Number of events 1 • From baseline (randomization) through last study follow-up visit, up to 20 months per participant.
Serious Adverse Events can be downgraded by Medical Monitor if no harm, hospitalization, or any changes need to be made for participant for grade severity. No deaths or serious adverse events occurred during the study. There were zero Serious Adverse Events during the time of the study as no participants were hospitalized or had any harm occur.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place