A Study of Intravenously Administered Tamiflu (Oseltamivi... | NCT01050257

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oseltamivir (TAMIFLU®) 100 mg	Experimental	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.	Drug: Oseltamivir IV Drug: Oseltamivir Oral
Oseltamivir (TAMIFLU®) 200 mg	Experimental	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.	Drug: Oseltamivir IV Drug: Oseltamivir Oral
Oseltamivir Open Label	Experimental	Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.	Drug: Oseltamivir IV Drug: Oseltamivir Oral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oseltamivir IV	Drug	Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment. Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death	Safety was assessed by adverse events (AEs) as measured by the collection of AEs, vital signs, electrocardiograms and laboratory parameters. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. On treatment = AEs that started between the day of first dose and within 2 days after the last dose. Off treatment = AEs that started more than 2 days after the last dose of study drug.	Up to 30 days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics		Days 1, 3
Percentage of Participants With Viral Shedding by Culture or RT-PCR	Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture [log10 median tissue culture infective dose (TCID50) > 0.5) or detection by RT-PCR (log 10 copies/mL).](streamdown:incomplete-link)

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35233	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
BG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
BG002	Oseltamivir Open Label	Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Death

Title	Measurements
	OG0001 OG0011 OG0023

AEs on treatment: IV dose

Secondary

Pharmacokinetics

Not Posted

Dec 2013

Days 1, 3

Secondary

Percentage of Participants With Viral Shedding by Culture or RT-PCR

Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture [log10 median tissue culture infective dose (TCID50) > 0.5) or detection by RT-PCR (log 10 copies/mL).](streamdown:incomplete-link)

Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.

Posted

Number

Percentage of participants

Days 1, 4, 6, 11, 15 and 30

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Secondary

Percentage of Participants With Viral Shedding by Culture

Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture=log10 median tissue culture infective dose (TCID50) > 0.5.

Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.

Posted

Number

Percentage of participants

Days 1, 4, 6, 11, 15, 30

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Secondary

Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by detection by RT-PCR (log 10 copies/mL).

Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.

Posted

Number

Percentage of participants

Days 1, 4, 6, 11, 15 and 30

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Secondary

Change From Baseline in Influenza Titer by Culture at Day 4

Nasal and throat swabs collected at Baseline and Day 4 were sent to a laboratory for analysis. Viral influenza titer (amount of virus present) was determined by culture. A log 10 median tissue culture infective dose (TCID50) > 0.5= Positive culture. A negative change from Baseline indicated improvement (less virus present).

Participants from the Intent-to-treat Influenza Infected population with data available for analysis. Only participants with positive influenza results are included.

Posted

Mean

Standard Deviation

log10 TCID50

Baseline, Day 4

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Secondary

Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4

Nasal and throat swabs were collected at Baseline and Day 4 and were sent to a central laboratory for analysis. Influenza Viral titers (amount of virus present) were determined by RT-PCR for Flu A and Flu B and were reported in log 10 copies/milliliter (mL). A negative change from Baseline indicated improvement (less virus present).

Participants from the Intent-to-Treat Infected population with data available for analysis. Only participants with positive influenza results are included.

Posted

Mean

Standard Deviation

log 10 copies/mL

Baseline, Day 4

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Secondary

Percentage of Participants Who Had a Fever During the Study

Fever was defined as a temperature of ≥ 37.8 C (degrees Celcius).

Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.

Posted

Number

Percentage of participants

Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Secondary

Time to Resolution of Fever for Participants Who Had a Fever at Baseline

Fever was defined as a temperature of ≥ 37.8 C (degrees Celsius). Resolution of fever was a temperature ≤ 37.2 for at least 21.5 hours.

Participants from the Intent-to-Treat Infected population, all treated participants with confirmed influenza infection by culture or RT-PCR, who had a fever at Baseline.

Posted

Median

95% Confidence Interval

Hours

Baseline, Up to 30 Days

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Secondary

Number of Participants With Viral Resistance

Nasal and Throat swabs were collected on Days 1, 4, 6, 11, 15 and 30 and were sent to a central laboratory for testing. Viral resistance was determined by phenotypic and genotypic testing.

Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.

Posted

Number

Participants

30 days

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Secondary

Percentage of Participants With Influenza Symptoms

Influenza (flu) symptoms were nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills.

Intent-to-Treat population included all treated participants.

Posted

Number

Percentage of participants

Days 1, 11, 15, 30

ID	Title	Description
OG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
OG002

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Oseltamivir (TAMIFLU®) 100 mg	Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.	9	48	17	48
EG001	Oseltamivir (TAMIFLU®) 200 mg	Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.	5	51	18	51
EG002	Oseltamivir Open Label	Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.	7	14	10	14

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Renal failure acute	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0020 affected14 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0020 affected14 at risk
Sepsis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0020 affected14 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0020 affected14 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0020 affected14 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0020 affected14 at risk
Abortion threatened	Pregnancy, puerperium and perinatal conditions	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0020 affected14 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected48 at risk EG0010 affected51 at risk EG0020 affected14 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0021 affected14 at risk
Pyrexia	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0020 affected14 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0020 affected14 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0020 affected14 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0020 affected14 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Cardiac arrest	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Hypotension	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Renal failure	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0020 affected14 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0006 affected48 at risk EG0011 affected51 at risk EG0021 affected14 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected48 at risk EG0014 affected51 at risk EG0020 affected14 at risk
Constipation	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected48 at risk EG0013 affected51 at risk EG0021 affected14 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected48 at risk EG0011 affected51 at risk EG0020 affected14 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Headache	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0014 affected51 at risk EG0022 affected14 at risk
Dizziness	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Anxiety	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected48 at risk EG0011 affected51 at risk EG0021 affected14 at risk
Agitation	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Delirium	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Depression	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Infusion site pain	General disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected48 at risk EG0014 affected51 at risk EG0020 affected14 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected48 at risk EG0011 affected51 at risk EG0022 affected14 at risk
Hypertension	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected48 at risk EG0011 affected51 at risk EG0021 affected14 at risk
Hypotension	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0022 affected14 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0021 affected14 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0021 affected14 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0022 affected14 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected48 at risk EG0010 affected51 at risk EG0022 affected14 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0011 affected51 at risk EG0021 affected14 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk
Blood magnesium decreased	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected48 at risk EG0010 affected51 at risk EG0021 affected14 at risk

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