EINSTEIN Junior: Oral Rivaroxaban in Children With Venous... | NCT02234843

NCT02234843

ID	Type	Description	Link
2014-000565-47	EudraCT Number

Status Module

Name	Class
Janssen Research & Development, LLC	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BAY59-7939	Experimental	Rivaroxaban (tablets and oral suspension) Dose: Age and body weight-adjusted dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban.	Drug: Rivaroxaban (Xarelto, BAY59-7939)
Standard of Care	Experimental	Subcutaneous low molecular weight heparin (LMWH), subcutaneous fondaparinux and/or oral vitamin K antagonist (VKA) Dose : as per standard of care	Drug: Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban (Xarelto, BAY59-7939)	Drug	Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets	BAY59-7939

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period	The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population	During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)
Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period	The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population	During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period	Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.	During extended treatment period: up to month 12.
Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication)

Secondary Outcomes

Measure	Description	Time Frame
Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period	The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36006613	Derived	Palumbo JS, Lensing AWA, Brandao LR, Hooimeijer HL, Kenet G, van Ommen H, Pap AF, Majumder M, Kubitza D, Thelen K, Willmann S, Prins MH, Monagle P, Male C. Anticoagulation in pediatric cancer-associated venous thromboembolism: a subgroup analysis of EINSTEIN-Jr. Blood Adv. 2022 Nov 22;6(22):5821-5828. doi: 10.1182/bloodadvances.2022008160.
33351120

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 27, 2017	Jan 29, 2020

Arm/Group Information

ID	Title	Description
BG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
BG001	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
BG002	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
BG003	Rivaroxaban, Aged 0.5-<2	Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
BG004	Rivaroxaban, Aged Birth-<0.5	Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.
BG005	Comparator, Aged 12-<18	Children aged 12-<18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
BG006	Comparator, Aged 6-<12	Children aged 6-<12 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
BG007	Comparator, Aged 2-<6	Children aged 2-<6 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
BG008	Comparator, Aged 0.5-<2	Children aged 0.5-<2 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
BG009	Comparator, Aged Birth-<0.5	Children aged birth-<0.5 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
BG010	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

Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period

The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population

Full analysis set (FAS)

Posted

Number

95% Confidence Interval

Percentage of participants

During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)

ID	Title	Description
OG000	Rivaroxaban Group	Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
OG001	Comparator Group	Children randomized to the comparator group will continue with UFH, LMWH or fondaparinux or may switch to VKA therapy. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux can be discontinued once the INR is above 2.0 on two separate occasions, 24 hours apart

Units	Counts
Participants	OG000335 OG001165

Title

Denominators

Categories

Title	Measurements
	OG0001.2(0.4 to 3.0) OG0013.0(1.2 to 6.6)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Expl. Cox Proportional Hazards Model		0.1509		Hazard Ratio (HR)	0.4			2-Sided	95	0.11	1.41					Other

Primary

Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period

Full analysis set (FAS)

Posted

Number

95% Confidence Interval

Percentage of participants

During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
OG002

Primary

Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period

Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.

Full analysis set (FAS)

Posted

Number

95% Confidence Interval

Percentage of participants

During extended treatment period: up to month 12.

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001	Comparator, Aged 12-<18	Children aged 12-<18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.

Primary

Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication)

The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.

Full analysis set (FAS)

Posted

Count of Participants

Participants

More than 2 and up to 30 days after stop of study medication

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001	Comparator, Aged 12-<18	Children aged 12-<18 years randomized to the comparator group continued with unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or may switch to VKA therapy. VKA dosages were adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux could be discontinued once the INR was above 2.0 on two separate occasions, 24 hours apart.
OG002	Rivaroxaban, Aged 6-<12

Primary

Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period

The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization).

Safety analysis set (SAF)

Posted

Number

95% Confidence Interval

Percentage of participants

During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)

ID	Title	Description
OG000	Rivaroxaban Group	Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Primary

Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period

Safety analysis set (SAF)

Posted

Number

95% Confidence Interval

Percentage of participants

During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001

Primary

Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period

Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life.

Safety analysis set (SAF)

Posted

Number

95% Confidence Interval

Percentage of participants

During extended treatment period: up to month 12.

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001

Secondary

Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period

The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population

Full analysis set (FAS)

Posted

Number

95% Confidence Interval

Percentage of participants

During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Secondary

AUC(0-24)ss in Plasma

AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.

Pharmacokinetics analysis set (PKS)

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram*hour per liter

over 24 hours

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
OG002	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Secondary

Cmax,ss in Plasma

Maximum drug concentration in measured matrix at steady state during a dosage interval

Pharmacokinetics analysis set (PKS)

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram per liter

0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
OG002	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Secondary

Ctrough,ss in Plasma

Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state

Pharmacokinetics analysis set (PKS)

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram per liter

0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.
OG001	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.
OG002	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Secondary

Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.

Units	Counts
Participants	OG000

Secondary

Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 0.5-<2	Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratios

Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 0.5-<2	Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged Birth-<0.5	Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.

Units	Counts
Participants	OG000

Secondary

Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 0.5-<2	Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 0.5-<2	Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

ratio

Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged Birth-<0.5	Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

microgram per liter (mcg/L)

Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90

ID	Title	Description
OG000	Rivaroxaban, Aged 12-<18	Children aged 12-<18 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension.

Units	Counts
Participants	OG000

Secondary

Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

microgram per liter (mcg/L)

Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90

ID	Title	Description
OG000	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

microgram per liter (mcg/L)

Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90

ID	Title	Description
OG000	Rivaroxaban, Aged 6-<12	Children aged 6-<12 years randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

microgram per liter (mcg/L)

Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90

ID	Title	Description
OG000	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

microgram per liter (mcg/L)

Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged 0.5-<2	Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

microgram per liter (mcg/L)

Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90

ID	Title	Description
OG000	Rivaroxaban, Aged 2-<6	Children aged 2-<6 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

microgram per liter (mcg/L)

Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, up to 16 hours on Day 90 and follow-up up to 30 days

ID	Title	Description
OG000	Rivaroxaban, Aged 0.5-<2	Children aged 0.5-<2 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Secondary

Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.

Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.

Posted

Mean

Standard Deviation

microgram per liter (mcg/L)

Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

ID	Title	Description
OG000	Rivaroxaban, Aged Birth-<0.5	Children aged birth-<0.5 years randomized to rivaroxaban received oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux . Children with body weight of < 20 kg received rivaroxaban as oral suspension.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Comparator Group	Children randomized to the comparator group will continue with UFH, LMWH or fondaparinux or may switch to VKA therapy. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux can be discontinued once the INR is above 2.0 on two separate occasions, 24 hours apart	0	162	35	162	121	162
EG001	Rivaroxaban Group	Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of < 20 kg received rivaroxaban as oral suspension.	2	329	78	329	275	329

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0019 events8 affected329 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0010 events0 affected329 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Postural orthostatic tachycardia syndrome	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Muscular dystrophy	Congenital, familial and genetic disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Papilloedema	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Retinal haemorrhage	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Intestinal dilatation	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0016 events6 affected329 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Chest pain	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Pyrexia	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events2 affected162 at risk EG0016 events6 affected329 at risk
Peripheral swelling	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Autoimmune disorder	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events1 affected329 at risk
Bacteraemia	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Bronchiolitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Eczema herpeticum	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Herpes zoster	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Mastoiditis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Meningitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Meningitis bacterial	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events2 affected329 at risk
Peritonitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Pneumonia viral	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Pyoderma streptococcal	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Tonsillitis streptococcal	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Varicella	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Viral infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Wound infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Gastritis viral	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Bacterial sepsis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Implant site infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Device related infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Infected dermal cyst	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Candida infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Accidental underdose	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Incorrect route of product administration	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Blood bilirubin increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Oxygen saturation decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Drug clearance decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Gastrointestinal stoma output decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Craniopharyngioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Myxofibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Dizziness	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Dysaesthesia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Epilepsy	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Headache	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events3 affected162 at risk EG0012 events2 affected329 at risk
Hemiparesis	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Neuralgia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Seizure	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Syncope	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Sciatic nerve neuropathy	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Encephalitis autoimmune	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0010 events0 affected329 at risk
Hemianaesthesia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hemiparaesthesia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Confusional state	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Drug abuse	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
IgA nephropathy	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Nephropathy	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Renal impairment	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Diaphragmatic paralysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pulmonary vein stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Colostomy	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Mastoidectomy	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Sclerotherapy	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Lumboperitoneal shunt	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Faecal disimpaction	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Haematoma	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Haemorrhage	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Device malfunction	Product Issues	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0005 events5 affected162 at risk EG00120 events11 affected329 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events3 affected162 at risk EG0011 events1 affected329 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events2 affected329 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0018 events4 affected329 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0012 events2 affected329 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0015 events1 affected329 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG0017 events6 affected329 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG00115 events10 affected329 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0012 events1 affected329 at risk
Autoimmune neutropenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Cytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0010 events0 affected329 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Bradycardia	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Palpitations	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Tachycardia	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0016 events6 affected329 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Immunodeficiency congenital	Congenital, familial and genetic disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Protein S deficiency	Congenital, familial and genetic disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Conductive deafness	Ear and labyrinth disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Deafness	Ear and labyrinth disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0017 events6 affected329 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Ear pruritus	Ear and labyrinth disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Cushingoid	Endocrine disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Amblyopia	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Astigmatism	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Cataract	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Diplopia	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Eye inflammation	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Eye irritation	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Eye pain	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Eye swelling	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Eyelid ptosis	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Glaucoma	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Heterophoria	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Myopia	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Ocular hyperaemia	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Ocular hypertension	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Optic disc haemorrhage	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Papilloedema	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events3 affected162 at risk EG0015 events4 affected329 at risk
Photophobia	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Retinal haemorrhage	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Strabismus	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Vision blurred	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Visual impairment	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Eye pruritus	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG00011 events9 affected162 at risk EG00127 events17 affected329 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG00112 events11 affected329 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events1 affected329 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Breath odour	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG00010 events10 affected162 at risk EG00111 events8 affected329 at risk
Dental caries	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG00012 events11 affected162 at risk EG00130 events25 affected329 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Flatulence	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG00113 events13 affected329 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Glossitis	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0016 events6 affected329 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0007 events6 affected162 at risk EG00125 events22 affected329 at risk
Oral pain	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events3 affected162 at risk EG0018 events7 affected329 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0017 events4 affected329 at risk
Tongue blistering	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Tongue coated	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Tongue geographic	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Toothache	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0014 events3 affected329 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG00017 events13 affected162 at risk EG00142 events36 affected329 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Perianal erythema	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Appendix disorder	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Tooth socket haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Asthenia	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0015 events3 affected329 at risk
Chest discomfort	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Chest pain	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0006 events5 affected162 at risk EG00118 events16 affected329 at risk
Cyst	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Fatigue	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0006 events6 affected162 at risk EG00123 events21 affected329 at risk
Feeling abnormal	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Feeling cold	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Gait disturbance	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Granuloma	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hyperthermia	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hypothermia	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Influenza like illness	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Injection site bruising	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0008 events8 affected162 at risk EG0010 events0 affected329 at risk
Injection site extravasation	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0010 events0 affected329 at risk
Injection site haematoma	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events3 affected162 at risk EG0010 events0 affected329 at risk
Injection site haemorrhage	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Injection site induration	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events1 affected162 at risk EG0010 events0 affected329 at risk
Injection site mass	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Injection site pruritus	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Malaise	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Mucosal inflammation	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events4 affected329 at risk
Oedema	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Oedema peripheral	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0014 events4 affected329 at risk
Pain	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0017 events7 affected329 at risk
Pyrexia	General disorders	MedDRA 21.1	Non-systematic Assessment	EG00022 events14 affected162 at risk EG00151 events37 affected329 at risk
Application site vesicles	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Peripheral swelling	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0005 events4 affected162 at risk EG0015 events5 affected329 at risk
Catheter site haemorrhage	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Puncture site haemorrhage	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0008 events5 affected162 at risk EG0011 events1 affected329 at risk
Catheter site pain	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Catheter site rash	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Vessel puncture site haemorrhage	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Nodule	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Application site hypersensitivity	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Infusion site extravasation	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Vaccination site pain	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Medical device site haemorrhage	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Allergy to animal	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0010 events0 affected329 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Serum sickness	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Seasonal allergy	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Secondary immunodeficiency	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Graft versus host disease in skin	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Graft versus host disease in liver	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Angular cheilitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Bacteriuria	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Bronchiolitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Bronchitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events4 affected329 at risk
Cellulitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0014 events3 affected329 at risk
Ear infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Eye infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Eyelid infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Folliculitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0012 events2 affected329 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0017 events7 affected329 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events4 affected329 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Giardiasis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Herpes virus infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Herpes zoster	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hordeolum	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Impetigo	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Influenza	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0004 events3 affected162 at risk EG0016 events6 affected329 at risk
Injection site infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Localised infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events3 affected329 at risk
Mastoiditis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG00013 events10 affected162 at risk EG00136 events29 affected329 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0015 events5 affected329 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Otitis media	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Otitis media acute	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Otitis media chronic	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Paronychia	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Periodontitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Pharyngitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG0012 events2 affected329 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0003 events1 affected162 at risk EG0012 events2 affected329 at risk
Pneumonia	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Rhinitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG00112 events11 affected329 at risk
Scarlet fever	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Sinusitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0016 events6 affected329 at risk
Skin infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Tonsillitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG0015 events5 affected329 at risk
Tooth abscess	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0008 events8 affected162 at risk EG00113 events10 affected329 at risk
Urethritis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0014 events4 affected329 at risk
Varicella	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Viral infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0014 events4 affected329 at risk
Viral pharyngitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Viral rash	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Vulvitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Wound infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Oral infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Tooth infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Abscess limb	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Cardiac infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Tinea versicolour	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Catheter site infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Enteritis infectious	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Implant site infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Sinusitis bacterial	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Adenovirus infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Bacterial infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Mastoid abscess	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Ear infection viral	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Acarodermatitis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Device related infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Oral herpes	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0015 events4 affected329 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Candida infection	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0017 events7 affected329 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0016 events5 affected329 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Greenstick fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0003 events3 affected162 at risk EG0014 events2 affected329 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0003 events3 affected162 at risk EG0011 events1 affected329 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0005 events5 affected162 at risk EG00121 events14 affected329 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events2 affected329 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Mouth injury	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Exposure to communicable disease	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG00010 events9 affected162 at risk EG00119 events15 affected329 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events4 affected329 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0003 events2 affected162 at risk EG00114 events13 affected329 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Underdose	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Stoma site rash	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0014 events4 affected329 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0014 events4 affected329 at risk
Anaphylactic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0010 events0 affected329 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Stoma site erythema	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Accidental underdose	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0018 events7 affected329 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Cerebral radiation injury	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Product prescribing error	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Alanine aminotransferase abnormal	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG00010 events6 affected162 at risk EG00111 events6 affected329 at risk
Aspartate aminotransferase abnormal	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG00110 events6 affected329 at risk
Aspiration bone marrow	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Bilirubin conjugated increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events3 affected329 at risk
Biopsy liver	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Blood bicarbonate decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Blood bilirubin increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0014 events4 affected329 at risk
Blood bilirubin unconjugated increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Blood glucose decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
C-reactive protein increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Cardiac murmur	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Coagulation factor VIII level increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Fibrin D dimer increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Full blood count abnormal	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Haemoglobin decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
International normalised ratio abnormal	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Lumbar puncture	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events1 affected329 at risk
Lymphocyte count increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Neutrophil count decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events2 affected329 at risk
Neutrophil count increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Nuclear magnetic resonance imaging	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Oxygen saturation decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Platelet count decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG00120 events9 affected329 at risk
Prothrombin time prolonged	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Weight increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
White blood cell count decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Blood phosphorus decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Platelet count increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Lymphocyte percentage decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Lipoprotein (a) increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Transaminases increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Bacterial test positive	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Blood alkaline phosphatase decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Anticoagulation drug level below therapeutic	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hepatic enzyme increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Angiogram	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Vitamin D decreased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Epstein-Barr virus test positive	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Clostridium test positive	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Staphylococcus test positive	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Chlamydia test positive	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Influenza B virus test positive	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Influenza A virus test positive	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Human rhinovirus test positive	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Liver function test increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0018 events8 affected329 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events2 affected329 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events2 affected329 at risk
Selenium deficiency	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Hyperhomocysteinaemia	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0017 events6 affected329 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG00113 events12 affected329 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events3 affected162 at risk EG00111 events11 affected329 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0013 events1 affected329 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0015 events5 affected329 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0015 events4 affected329 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0016 events6 affected329 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG00012 events9 affected162 at risk EG00125 events23 affected329 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events3 affected329 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Craniopharyngioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Ewing's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Lymphangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Clumsiness	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Dizziness	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG00111 events11 affected329 at risk
Dizziness exertional	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Head discomfort	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Headache	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG00028 events24 affected162 at risk EG00175 events56 affected329 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hypersomnia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hypotonia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Memory impairment	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Migraine	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Muscle contractions involuntary	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0015 events5 affected329 at risk
Presyncope	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Seizure	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Syncope	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Tension headache	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Tremor	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Balance disorder	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
VIth nerve disorder	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Toxic neuropathy	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Choroid fissure cyst	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Agitation	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Anxiety	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0015 events4 affected329 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Depressed mood	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Depression	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Disorientation	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Emotional disorder	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Insomnia	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Mood altered	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Nervousness	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Panic attack	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Somnambulism	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Phonophobia	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Post stroke depression	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0018 events5 affected329 at risk
Hypercalciuria	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Renal atrophy	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0015 events4 affected329 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 events1 affected162 at risk EG0012 events2 affected329 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG00111 events4 affected329 at risk
Genital rash	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0006 events5 affected162 at risk EG00129 events21 affected329 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Polycystic ovaries	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Priapism	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG00110 events4 affected329 at risk
Genital tract inflammation	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Perineal erythema	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG00011 events11 affected162 at risk EG00120 events18 affected329 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0018 events7 affected329 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG00032 events20 affected162 at risk EG00162 events40 affected329 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0004 events3 affected162 at risk EG0017 events6 affected329 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pleural adhesion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events2 affected329 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG00116 events13 affected329 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Mediastinal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Oropharyngeal plaque	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG0019 events8 affected329 at risk
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0005 events5 affected162 at risk EG0018 events8 affected329 at risk
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0011 events1 affected329 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0011 events1 affected329 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events4 affected329 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0010 events0 affected329 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0012 events2 affected329 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0018 events6 affected329 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Livedo reticularis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0018 events8 affected329 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0004 events4 affected162 at risk EG00119 events17 affected329 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Rash follicular	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events1 affected162 at risk EG0011 events1 affected329 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0011 events1 affected329 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Skin striae	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Umbilical haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0013 events3 affected329 at risk
Skin swelling	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0014 events4 affected329 at risk
Bladder catheterisation	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Intra-uterine contraceptive device insertion	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Ventricular drainage	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Gastrointestinal tube insertion	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Central venous catheterisation	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0013 events3 affected329 at risk
Hepatitis B immunisation	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Oophorectomy	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Mastoid operation	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0015 events4 affected329 at risk
Stem cell transplant	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events1 affected329 at risk
Central venous catheter removal	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Endotracheal intubation	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Ventriculo-cardiac shunt	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Laryngeal mask airway insertion	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Arterial thrombosis	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Flushing	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0012 events2 affected329 at risk
Haematoma	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk
Hypertension	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 events2 affected162 at risk EG0014 events3 affected329 at risk
Hypotension	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Pallor	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0015 events2 affected329 at risk
Phlebitis	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Varicose vein	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Post thrombotic syndrome	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0014 events3 affected329 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Extremity necrosis	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Hot flush	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 events0 affected162 at risk EG0011 events1 affected329 at risk
Superficial vein prominence	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
May-Thurner syndrome	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Device leakage	Product Issues	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0010 events0 affected329 at risk
Device occlusion	Product Issues	MedDRA 21.1	Non-systematic Assessment	EG0001 events1 affected162 at risk EG0012 events2 affected329 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85016	United States

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation