A Study of Intravenous Oseltamivir [Tamiflu] in Infants W... | NCT01053663

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
1	Experimental		Drug: Tamiflu

Name	Type	Description	Arm Group Labels	Other Names
Tamiflu	Drug	10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1		Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2		Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4		Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1		Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1
Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2		Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2
Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4		Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4

Secondary Outcomes

Measure	Description	Time Frame
Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate		Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Little Rock	Arkansas	45229-3039	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26042486	Derived	Munoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Oseltamivir - All Participants	Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's age. Participants aged 91 to less than (<) 365 days received 3 milligrams per kilogram (mg/kg); participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
BG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
BG002	Oseltamivir: Age 0 to 30 Days	Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1

Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.

Posted

Geometric Mean

Geometric Coefficient of Variation

hour*nanogram/milliliter (h*ng/mL)

Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002	Oseltamivir: Age 0 to 30 Days	Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.

Units	Counts
Participants	OG0003 OG0010 OG0021

Title

Denominators

Categories

Oseltamivir

Title	Measurements
	OG000777± 162.8 OG002494

Oseltamivir Carboxylate

Title	Measurements
	OG000

Primary

AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2

PK population. Number of participants analyzed = participants who were evaluable for this outcome.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002	Oseltamivir: Age 0 to 30 Days	Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.

Primary

AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4

PK population. Number of participants analyzed = participants who were evaluable for this outcome.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002	Oseltamivir: Age 0 to 30 Days	Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.

Primary

Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1

PK population. Number of participants analyzed = participants who were evaluable for this outcome.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram/milliliter (ng/mL)

Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002	Oseltamivir: Age 0 to 30 Days

Primary

Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2

PK population. Number of participants analyzed = participants who were evaluable for this outcome.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002	Oseltamivir: Age 0 to 30 Days	Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.

Primary

Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4

PK population. Number of participants analyzed = participants who were evaluable for this outcome.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002	Oseltamivir: Age 0 to 30 Days	Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.

Secondary

Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate

PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002

Secondary

Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate

PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002

Secondary

Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate

PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002

Secondary

Number of Participants With Greater Than or Equal to (≥) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values

IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either ≥5 times change in the NAI IC50 visit value from the Reference value at a visit or ≥5 times change in the NAI IC50 Visit value from the Baseline value.

Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.

Posted

Number

participants

Baseline, Days 1, 3, 4, 6, 15

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.

Secondary

Number of Participants With Oseltamivir Resistance Mutation

Resistance was assessed by neuraminidase (NA) and hemagglutinin (HA) genes sequencing analysis, using Reverse Transcription Polymerase Chain Reaction (RT-PCR).

Safety population.

Posted

Number

participants

Up to Day 30

ID	Title	Description
OG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
OG002	Oseltamivir: Age 0 to 30 Days

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Oseltamivir: Age 91 to < 365 Days	Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.	5	7	4	7
EG001	Oseltamivir: Age 31 to 90 Days	Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.	0	1	0	1
EG002	Oseltamivir: Age 0 to 30 Days	Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.	0	1	1	1
EG003	Oseltamivir: All Participants	Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.	5	9	5	9

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Multi-Organ Failure	General disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG0031 affected9 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Respiratory Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG0031 affected9 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected1 at risk EG0021 affected1 at risk EG003
Application Site Vesicles	General disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected1 at risk EG0021 affected1 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected1 at risk EG0021 affected1 at risk EG003
Brain Oedema	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected1 at risk EG0021 affected1 at risk EG003
Hypotension	Vascular disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003

Certain Agreements

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D053138	Cyclohexenes
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons