Trial Outcomes & Findings for Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza (NCT NCT00391768)
NCT ID: NCT00391768
Last Updated: 2013-05-01
Results Overview
The oseltamivir carboxylate AUC12 was derived from a series of five blood draws over 10 to 12 hours.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Day 3 of drug administration
Results posted on
2013-05-01
Participant Flow
Patients were recruited from the emergency department, hospital, physician's office or clinical care unit. Children of both sexes and all races were included. The recruitment period was January 2007 through May 2010.
Participant milestones
| Measure |
Cohort IA
12 - 23 months of age, 30 mg
|
Cohort IB
12 - 23 months of age, 3.5 mg/kg body weight
|
Cohort IIA
9 - 11 months of age, 3 mg/kg body weight
|
Cohort IIB
9 to 11 months of age, 3.5 mg/kg body weight
|
Cohort III
6 to 8 months of age, 3 mg/kg body weight
|
Cohort IV
3 to 5 months of age, 3 mg/kg body weight
|
Cohort V
0 to 2 months of age, 3 mg/kg body weight
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
3
|
7
|
8
|
24
|
10
|
23
|
|
Overall Study
COMPLETED
|
12
|
3
|
6
|
7
|
22
|
7
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
Cohort IA
12 - 23 months of age, 30 mg
|
Cohort IB
12 - 23 months of age, 3.5 mg/kg body weight
|
Cohort IIA
9 - 11 months of age, 3 mg/kg body weight
|
Cohort IIB
9 to 11 months of age, 3.5 mg/kg body weight
|
Cohort III
6 to 8 months of age, 3 mg/kg body weight
|
Cohort IV
3 to 5 months of age, 3 mg/kg body weight
|
Cohort V
0 to 2 months of age, 3 mg/kg body weight
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
2
|
3
|
Baseline Characteristics
Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
Baseline characteristics by cohort
| Measure |
Cohort IA
n=12 Participants
12 - 23 months of age, 30 mg
|
Cohort IB
n=3 Participants
12 - 23 months of age, 3.5 mg/kg body weight
|
Cohort IIA
n=7 Participants
9 - 11 months of age, 3 mg/kg body weight
|
Cohort IIB
n=8 Participants
9 to 11 months of age, 3.5 mg/kg body weight
|
Cohort III
n=24 Participants
6 to 8 months of age, 3 mg/kg body weight
|
Cohort IV
n=10 Participants
3 to 5 months of age, 3 mg/kg body weight
|
Cohort V
n=23 Participants
0 to 2 months of age, 3 mg/kg body weight
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
87 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
36 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
51 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
24 participants
n=21 Participants
|
10 participants
n=10 Participants
|
23 participants
n=115 Participants
|
87 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 3 of drug administrationPopulation: Subjects that received 3 days study drug administration and had successful PK draws on study day 3.
The oseltamivir carboxylate AUC12 was derived from a series of five blood draws over 10 to 12 hours.
Outcome measures
| Measure |
Cohort IA
n=10 Participants
Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
|
Cohort IB
n=3 Participants
Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIA
n=6 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIB
n=7 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort III
n=22 Participants
Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IV
n=10 Participants
Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort V
n=19 Participants
Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
|---|---|---|---|---|---|---|---|
|
Oseltamivir Carboxylate AUC12 (Area Under the Curve).
AUC12 <2660
|
6 participants
|
1 participants
|
3 participants
|
0 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Oseltamivir Carboxylate AUC12 (Area Under the Curve).
AUC12 > or = 2660 and <7700
|
4 participants
|
2 participants
|
3 participants
|
7 participants
|
19 participants
|
10 participants
|
13 participants
|
|
Oseltamivir Carboxylate AUC12 (Area Under the Curve).
AUC12 > or =7700
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.Population: Intention to treat (ITT)
Any event considered associated with drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.
Outcome measures
| Measure |
Cohort IA
n=12 Participants
Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
|
Cohort IB
n=3 Participants
Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIA
n=7 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIB
n=8 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort III
n=24 Participants
Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IV
n=10 Participants
Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort V
n=23 Participants
Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy.
Event - Vomiting
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy.
Event - Dermatitis Diaper
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy.
Event - Rash
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.Population: Intention to treat (ITT)
Any neurological event that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.
Outcome measures
| Measure |
Cohort IA
n=12 Participants
Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
|
Cohort IB
n=3 Participants
Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIA
n=7 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIB
n=8 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort III
n=24 Participants
Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IV
n=10 Participants
Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort V
n=23 Participants
Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
|---|---|---|---|---|---|---|---|
|
Number and Characteristics of Adverse Events (AEs) Described as Neurological Events.
Event - Lethargy
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number and Characteristics of Adverse Events (AEs) Described as Neurological Events.
Event - Tremor
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 daysPopulation: Intention to treat (ITT)
Any event considered to be related to the study drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately. The Division of AIDS Toxicity Tables (DIAIDS) were used to grade the events.
Outcome measures
| Measure |
Cohort IA
n=12 Participants
Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
|
Cohort IB
n=3 Participants
Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIA
n=7 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIB
n=8 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort III
n=24 Participants
Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IV
n=10 Participants
Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort V
n=23 Participants
Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
|---|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade
Grade I - Mild
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade
Grade II - Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade
Grade III - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade
Grade IV - Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade
Grade V - Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 5 plus or minus 1 dayStudy drug was administered for 5 days; any event that occurred prior to the last dose of study medication that was considered related to an AE and that caused the subject to stop taking study drug.
Outcome measures
| Measure |
Cohort IA
n=12 Participants
Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
|
Cohort IB
n=3 Participants
Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIA
n=7 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIB
n=8 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort III
n=24 Participants
Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IV
n=10 Participants
Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort V
n=23 Participants
Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
|---|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort Leading to Discontinuation of Study Medication
|
0 events
|
0 events
|
1 events
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 daysSerious Adverse Event (SAE) were classified by MedDRA System Organ Class (SOC). An SAE was reported if it met the following criteria and occurred after the first dose of study medication through the end of the study: death throughout study participation; life threatening; requires inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance; results in congenital anomaly or birth defect; results in a persistent or significant disability; and an event considered serious by the PI.
Outcome measures
| Measure |
Cohort IA
n=12 Participants
Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
|
Cohort IB
n=3 Participants
Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIA
n=7 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIB
n=8 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort III
n=24 Participants
Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IV
n=10 Participants
Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort V
n=23 Participants
Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
|---|---|---|---|---|---|---|---|
|
Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)
General Disorders & Administration Site Conditions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)
Immune System Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)
Infections and Infestations
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)
Total
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)
Investigations
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)
Respiratory, thoracic & mediastinal disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day to negative viral load for subjects positive at baselinePopulation: Subjects included in this analysis are those who had positive culture at baseline (day 0) and had a negative culture on one of the following study visit days: Day 3, Day 5 or Day 10. Culture was obtained from a a nasal swab. Subjects also would have had evaluable PK samples on study day 3.
The Spearman coefficient and the p-values were computed between the clearance of Viral RNA and Oseltamivir Carboxylate Area under the curve from 0 to 12 hours (AUC0-12)
Outcome measures
| Measure |
Cohort IA
n=8 Participants
Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
|
Cohort IB
n=2 Participants
Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIA
n=4 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIB
n=5 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort III
n=12 Participants
Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IV
n=8 Participants
Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort V
n=18 Participants
Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
|---|---|---|---|---|---|---|---|
|
Correlation of Clearance of Viral RNA by Culture With Pharmacokinetic Parameters by Cohort
|
0.67 Spearman coefficient
|
NA Spearman coefficient
too few subjects
|
0.40 Spearman coefficient
|
0.62 Spearman coefficient
|
0.09 Spearman coefficient
|
0.30 Spearman coefficient
|
0.01 Spearman coefficient
|
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented absence of viral load by culture, assessed up to 10 days after enrollment.Population: Subjects included in this analysis are those who had viral loads at baseline (day 0) and had a non-detectable viral load on one of the following study visit days: day 3, day 5, or day 10. Virus was obtained from a nasal swab. Subjects also would have had evaluable PK samples on study day 3.
The Spearman coefficient and the p-values were computed between the clearance of viral RNA and oseltamivir carboxylate Area Under the Curve from 0 to 12 hours (AUC 0-12)
Outcome measures
| Measure |
Cohort IA
n=10 Participants
Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
|
Cohort IB
n=2 Participants
Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIA
n=4 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IIB
n=5 Participants
Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort III
n=16 Participants
Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort IV
n=8 Participants
Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
Cohort V
n=18 Participants
Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
|
|---|---|---|---|---|---|---|---|
|
Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort.
AUC0-12 (hr*ng/mL) unit: Spearman Coefficient
|
0.57 correlation measure
|
NA correlation measure
too few subjects available
|
0.21 correlation measure
|
0.90 correlation measure
|
0.28 correlation measure
|
0.04 correlation measure
|
0.07 correlation measure
|
|
Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort.
AUC0-12 (hr*ng/mL) unit: P value
|
0.08 correlation measure
|
NA correlation measure
too few subjects available
|
0.79 correlation measure
|
0.04 correlation measure
|
0.30 correlation measure
|
0.93 correlation measure
|
0.77 correlation measure
|
Adverse Events
Cohort IA
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort IB
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort IIA
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort IIB
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort III
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort IV
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort V
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort IA
n=12 participants at risk
12 - 23 months of age, 30 mg
|
Cohort IB
n=3 participants at risk
12 - 23 months of age, 3.5 mg/kg body weight
|
Cohort IIA
n=7 participants at risk
9 - 11 months of age, 3 mg/kg body weight
|
Cohort IIB
n=8 participants at risk
9 to 11 months of age, 3.5 mg/kg body weight
|
Cohort III
n=24 participants at risk
6 to 8 months of age, 3 mg/kg body weight
|
Cohort IV
n=10 participants at risk
3 to 5 months of age, 3 mg/kg body weight
|
Cohort V
n=23 participants at risk
0 to 2 months of age, 3 mg/kg body weight
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Pnuemonia
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
10.0%
1/10 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
Other adverse events
| Measure |
Cohort IA
n=12 participants at risk
12 - 23 months of age, 30 mg
|
Cohort IB
n=3 participants at risk
12 - 23 months of age, 3.5 mg/kg body weight
|
Cohort IIA
n=7 participants at risk
9 - 11 months of age, 3 mg/kg body weight
|
Cohort IIB
n=8 participants at risk
9 to 11 months of age, 3.5 mg/kg body weight
|
Cohort III
n=24 participants at risk
6 to 8 months of age, 3 mg/kg body weight
|
Cohort IV
n=10 participants at risk
3 to 5 months of age, 3 mg/kg body weight
|
Cohort V
n=23 participants at risk
0 to 2 months of age, 3 mg/kg body weight
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Candidiasis
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
33.3%
1/3 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Croup infectious
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
16.7%
2/12 • Number of events 3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
3/24 • Number of events 3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
10.0%
1/10 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
13.0%
3/23 • Number of events 3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Number of events 2 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
17.4%
4/23 • Number of events 4 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
8.3%
2/24 • Number of events 3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
General disorders
Injection site pain
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
8.3%
2/24 • Number of events 2 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Otitis media
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
16.7%
4/24 • Number of events 4 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
10.0%
1/10 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Pharyngitis streptococcal
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
8.3%
2/24 • Number of events 2 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
8.3%
2/24 • Number of events 2 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
8.7%
2/23 • Number of events 2 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
10.0%
1/10 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Roseola
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Skin infection
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Psychiatric disorders
Staring
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Tracheitis
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 2 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
33.3%
1/3 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
8.3%
2/24 • Number of events 2 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
14.3%
1/7 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.3%
1/23 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Viral infection
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/24 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • Number of events 4 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
12.5%
1/8 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
16.7%
4/24 • Number of events 4 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/3 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/7 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/8 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
4.2%
1/24 • Number of events 1 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/10 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
0.00%
0/23 • Adverse/Serious adverse events were collected from Day 1 to Day 30 of protocol
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place