Trial Outcomes & Findings for Asymptomatic Congenital CMV Treatment (NCT NCT03301415)

NCT ID: NCT03301415

Last Updated: 2023-01-26

Results Overview

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each subject and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 6 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 6 month follow-up.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: Between baseline and study month 6
• Results posted on: 2023-01-26

Participant Flow

Male and female infants with asymptomatic congenital CMV infection were recruited at participating sites between 20Aug2019 and 09SEP2020.

Participant milestones

Measure	Confirmed Congenital CMV Without Baseline SNHL Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Overall Study STARTED	7
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Confirmed Congenital CMV Without Baseline SNHL Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Overall Study Lost to Follow-up	2
Overall Study Unable to comply with visit schedule	2

Baseline Characteristics

Asymptomatic Congenital CMV Treatment

Baseline characteristics by cohort

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25.7 days STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Between baseline and study month 6

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study month 6 visit.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each subject and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 6 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 6 month follow-up.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=2 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
The Number of Participants Developing Sensorineural Hearing Loss (SNHL) in at Least One Ear Between Baseline and Study Month 6	0 Participants

SECONDARY outcome

Timeframe: Day 1 through Study month 5

Blood was collected for assessments of hematology and absolute neutrophil count was assessed at each study visit through Month 5

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Absolute Neutrophil Counts Below 500/mm^3	1 Participants

SECONDARY outcome

Timeframe: Day 1 through Study month 6

Population: All participants who have received at least one dose of study product and for whom any data on safety are available.

A count of participants discontinued from valganciclovir therapy due to adverse events were reported during the therapy period, and the count of participants with adverse events not recovered/not resolved were reported throughout the adverse event period.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Adverse Events Leading to Permanent Discontinuation of Valganciclovir Therapy, or Any Adverse Event That is Not Recovered / Not Resolved AEs leading to discontinuation	1 Participants
Number of Participants With Adverse Events Leading to Permanent Discontinuation of Valganciclovir Therapy, or Any Adverse Event That is Not Recovered / Not Resolved AEs not recovered/resolved	4 Participants

SECONDARY outcome

Timeframe: From day 1 through study month 6

Population: All participants who have received at least one dose of study product and for whom any safety data are available.

At each study visit from the receipt of first dose of study drug and continuing through four weeks following the final dose of study drug, the participants were assessed for any adverse events. Lab parameters included ALT, creatinine, direct bilirubin, white blood cell count with differential, hemoglobin, platelets count. Abnormal laboratory values were reported as an AE if they worsened in severity from baseline, per the grading definitions provided in the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Grade 3 or Higher Safety Laboratory Adverse Events	4 Participants

SECONDARY outcome

Timeframe: From day 1 through study month 6

Population: All participants who have received at least one dose of study product and for whom any safety data are available.

Serious adverse events were those defined as: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, or were important medical events that may not result in death, be life-threatening, or require hospitalizations may be considered serious when, based upon appropriate medical judgment they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: From day 1 through study month 6

Population: All participants who have received at least one dose of study product and for whom any safety data are available.

At each study visit from the receipt of first dose of study drug and continuing through four weeks following the final dose of study drug, the participants were assessed for any adverse events. Lab parameters included ALT, creatinine, direct bilirubin, white blood cell count with differential, hemoglobin, platelets count. Abnormal laboratory values were reported as an AE if they worsened in severity from baseline, per the grading definitions provided in the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Grade 3 or Higher Unsolicited Adverse Events Assessed by Adapted From DAIDS Toxicity Tables	4 Participants

SECONDARY outcome

Timeframe: Screening and Study Months 4, 6, 8 and 12

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study month 12 visit.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Mild Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Screening	0 Participants
Number of Participants With Mild Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 4	0 Participants
Number of Participants With Mild Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 6	0 Participants
Number of Participants With Mild Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 8	0 Participants
Number of Participants With Mild Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 12	0 Participants

SECONDARY outcome

Timeframe: Screening and Study Months 4, 6, 8 and 12

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study month 12 visit.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each subject and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Moderate Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Screening	0 Participants
Number of Participants With Moderate Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 4	0 Participants
Number of Participants With Moderate Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 6	0 Participants
Number of Participants With Moderate Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 8	0 Participants
Number of Participants With Moderate Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 12	0 Participants

SECONDARY outcome

Timeframe: Study Months 4, 6, 8 and 12

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study month 18 visit.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Profound Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Screening	0 Participants
Number of Participants With Profound Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 4	0 Participants
Number of Participants With Profound Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 6	0 Participants
Number of Participants With Profound Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 8	0 Participants
Number of Participants With Profound Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 12	0 Participants

SECONDARY outcome

Timeframe: Study Months 4, 6, 8 and 12

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study month 12 visit.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Severe Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Screening	0 Participants
Number of Participants With Severe Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 4	0 Participants
Number of Participants With Severe Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 6	0 Participants
Number of Participants With Severe Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 8	0 Participants
Number of Participants With Severe Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening Month 12	0 Participants

SECONDARY outcome

Timeframe: Between screening and study month 4

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study month 4 visit.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 4 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 4 month follow-up.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=5 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 4	0 Participants

SECONDARY outcome

Timeframe: Between screening and study month 12

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study month 12 visit.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 12 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 12 month follow-up.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=1 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 12	0 Participants

SECONDARY outcome

Timeframe: Between screening and study month 18

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study month 18 visit.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=1 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 18	0 Participants

SECONDARY outcome

Timeframe: Baseline, weeks 2, 4, 6, 8, 10, 12, months 4, 5 and 6.

Population: All participants who have received at least one dose of study product and for whom with any alanine aminotransferase result available from Day 1 through Month 6.

Blood was collected for assessments of clinical chemistry and alanine aminotransferase (ALT) was assessed at screening, week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Month 4, Month 5, and Month 6

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 Participants Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Participants With Transaminase Elevation During Treatment > / = 2 Times the Baseline Value	0 Participants

SECONDARY outcome

Timeframe: Screening and Study Months 4, 6, 12, and 18

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study months 4, 6, 12, 18.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels).

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=10 Ears Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Ears of Mild Worsened Hearing Month 4	0 Ears
Number of Ears of Mild Worsened Hearing Month 6	0 Ears
Number of Ears of Mild Worsened Hearing Month 12	0 Ears
Number of Ears of Mild Worsened Hearing Month 18	0 Ears

SECONDARY outcome

Timeframe: Screening and Study Months 4, 6, 12, and 18

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study months 4, 6, 12, 18.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels).

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=10 Ears Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Ears of Moderate Worsened Hearing Month 4	0 Ears
Number of Ears of Moderate Worsened Hearing Month 6	0 Ears
Number of Ears of Moderate Worsened Hearing Month 12	0 Ears
Number of Ears of Moderate Worsened Hearing Month 18	0 Ears

SECONDARY outcome

Timeframe: Screening and Study Months 4, 6, 12, and 18

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study months 4, 6, 12, 18.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels).

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=10 Ears Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Ears of Profound Worsened Hearing Month 4	0 Ears
Number of Ears of Profound Worsened Hearing Month 6	0 Ears
Number of Ears of Profound Worsened Hearing Month 12	0 Ears
Number of Ears of Profound Worsened Hearing Month 18	0 Ears

SECONDARY outcome

Timeframe: Screening and Study Months 4, 6, 12, and 18

Population: All participants who have received at least one dose of study product and with a normal baseline hearing assessment for both ears and with hearing assessment result available at Study months 4, 6, 12, 18.

Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels).

Outcome measures

Measure	Confirmed Congenital CMV Without Baseline SNHL n=10 Ears Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Number of Ears of Severe Worsened Hearing Month 4	0 Ears
Number of Ears of Severe Worsened Hearing Month 6	0 Ears
Number of Ears of Severe Worsened Hearing Month 12	0 Ears
Number of Ears of Severe Worsened Hearing Month 18	0 Ears

Adverse Events

Confirmed Congenital CMV Without Baseline SNHL

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Confirmed Congenital CMV Without Baseline SNHL n=7 participants at risk Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Blood and lymphatic system disorders Anaemia	42.9% 3/7 • Number of events 7 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Blood and lymphatic system disorders Neutropenia	100.0% 7/7 • Number of events 10 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Gastrointestinal disorders Abdominal pain upper	28.6% 2/7 • Number of events 2 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Gastrointestinal disorders Flatulence	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
General disorders Pyrexia	28.6% 2/7 • Number of events 2 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Infections and infestations Conjunctivitis	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Infections and infestations Oral candidiasis	14.3% 1/7 • Number of events 3 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Investigations Bilirubin conjugated increased	71.4% 5/7 • Number of events 5 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Investigations Haemoglobin decreased	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Investigations Monocyte count increased	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Nervous system disorders Somnolence	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	28.6% 2/7 • Number of events 3 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 1 • All AEs occurring from Study Day 1 through four weeks following the last four weeks following the last dose of study drug and laboratory AEs occurring through Study Month 6 were collected.

Additional Information

David W. Kimberlin, MD

The University of Alabama at Birmingham

Phone: 205-934-5316

Email: dkimberlin@peds.uab.edu

Results disclosure agreements

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

Restriction type: LTE60