A Safety Trial of Nivolumab in Patients With Advanced or... | NCT02066636

Status Module

Label	Type	Description	Intervention Names
Cohort A: Nivolumab	Experimental	Nivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent	Drug: Nivolumab
Cohort B: Nivolumab	Experimental	Nivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until 1 year (52 weeks). Discontinue treatment and at progression, retreatment allowed	Drug: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug		Cohort A: Nivolumab Cohort B: Nivolumab	BMS-936558

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)	A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

Secondary Outcomes

Measure	Description	Time Frame
Median Time to Onset of Select Adverse Events (Grade 3-5)	The time from first dose to the first occurrence of any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Target Population

Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if tests have not been previously performed. Subjects with progressive disease during or after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are eligible if genetic test results are indeterminate or if no tumor tissue is available or accessible for testing as long as they have received one prior systemic therapy
Experimental therapies when given as separate regimen are considered as separate line of therapy
Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1
Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
PS 0 to 1
PS 2

Exclusion Criteria:

Target Disease Exceptions
- Subjects with active central nervous system (CNS) metastases are excluded
- Subjects with carcinomatous meningitis
Medical History and Concurrent Diseases
- Subjects with a history of interstitial lung disease
- Subjects with active, known or suspected autoimmune disease
- Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents
Prohibited Treatments and/or Restricted Therapies
- Ongoing or planned administration of anti-cancer therapies other than those specified in this study
- Use of corticosteroids or other immunosuppressive medications

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southern Cancer Center Pc		Mobile	Alabama	36608	United States
Cancer Center Treatment Center of America

PubMed Identifier	Type	Citation	Retractions
31121324	Derived	Spigel DR, McCleod M, Jotte RM, Einhorn L, Horn L, Waterhouse DM, Creelan B, Babu S, Leighl NB, Chandler JC, Couture F, Keogh G, Goss G, Daniel DB, Garon EB, Schwartzberg LS, Sen R, Korytowsky B, Li A, Aanur N, Hussein MA. Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153). J Thorac Oncol. 2019 Sep;14(9):1628-1639. doi: 10.1016/j.jtho.2019.05.010. Epub 2019 May 20.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort A: Nivolumab Monotherapy	Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will continue to receive treatment until disease progression, unacceptable toxicity, or withdrawal of informed consent.

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_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 1, 2017

Arm/Group Information

ID	Title	Description
BG000	Cohort A: Nivolumab Monotherapy	Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will continue to receive treatment until disease progression, unacceptable toxicity, or withdrawal of informed consent.
BG001	Cohort B: Nivolumab Monotherapy	Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Each 14 day dosing period will constitute a cycle. After 1 year (52 weeks) of treatment all participants will discontinue treatment. Upon progression, participants can receive retreatment.
BG002	Nivolumab Monotherapy (Not Randomized)	Participants receive nivolumab administered intravenously at 3 mg/kg every two weeks. Non-randomized participants were those participants who were enrolled but (after 1 year) were not randomized to either of the study cohorts (Cohort A or B).
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)

A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

All treated participants prior to randomization and treated participants randomized to Cohort A and B

Posted

Count of Participants

Participants

From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

ID	Title	Description
OG000	Cohort A: Nivolumab Monotherapy (Post-Randomization)	All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
OG001	Cohort B: Nivolumab Monotherapy (Post-Randomization)	All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.
OG002	Nivolumab Monotherapy (Pre-Randomized)	All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.

Units	Counts
Participants	OG000127 OG001125 OG0021428

Title

Denominators

Categories

Gastrointestinal Adverse Event (Grade3-4)

Title	Measurements
	OG0003 OG0010 OG00220

Gastrointestinal Adverse Event (Grade 5)

Secondary

Median Time to Onset of Select Adverse Events (Grade 3-5)

The time from first dose to the first occurrence of any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category

Posted

Median

Full Range

Weeks

From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

ID	Title	Description
OG000	Cohort A: Nivolumab Monotherapy (Post-Randomization)	All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
OG001	Cohort B: Nivolumab Monotherapy (Post-Randomization)

Secondary

Median Time to Resolution of Select Adverse Events (Grade 3-5)

The time from the onset of any select adverse event of interest to its resolution or stabilization. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category

Posted

Median

Full Range

Weeks

From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

ID	Title	Description
OG000	Cohort A: Nivolumab Monotherapy (Post-Randomization)	All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
OG001	Cohort B: Nivolumab Monotherapy (Post-Randomization)

Secondary

The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events

The number of participants receiving medication meant to trigger an immune response for any select Adverse events of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category

Posted

Count of Participants

Participants

From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

ID	Title	Description
OG000	Cohort A: Nivolumab Monotherapy (Post-Randomization)	All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
OG001

Secondary

The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events

The number of participants receiving > 40mg prednisone equivalents for any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category

Posted

Count of Participants

Participants

From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

ID	Title	Description
OG000	Cohort A: Nivolumab Monotherapy (Post-Randomization)	All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
OG001	Cohort B: Nivolumab Monotherapy (Post-Randomization)

Secondary

The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events

The duration of time participants received medication meant to trigger an immune response for any select Adverse events of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

All treated participants (both included and excluded from Cohort randomization) with at least one select adverse event from the category

Posted

Median

Full Range

Weeks

From first dose first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

ID	Title	Description
OG000	Cohort A: Nivolumab Monotherapy (Post-Randomization)	All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
OG001	Cohort B: Nivolumab Monotherapy (Post-Randomization)

Secondary

The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.

All treated participants prior to randomization and treated participants randomized to Cohort A and B

Posted

Count of Participants

Participants

From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

ID	Title	Description
OG000	Cohort A: Nivolumab Monotherapy (Post-Randomization)	All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.
OG001	Cohort B: Nivolumab Monotherapy (Post-Randomization)	All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.

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	Cohort A: Nivolumab Monotherapy (Post-Randomization)	All participants that continued to receive treatment after completing 1 year (52 weeks) of nivolumab administered intravenously at 3 mg/kg every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent.	63	127	57	127	101	127
EG001	Cohort B: Nivolumab Monotherapy (Post-Randomization)	All participants that discontinued treatment after 1 year (52 weeks) of receiving nivolumab administered intravenously at 3 mg/kg every two weeks. Upon progression, participants can receive retreatment.	77	125	52	125	82	125
EG002	Nivolumab Monotherapy (Pre-Randomized)	All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks for up to 1 year.	1,040	1,428	870	1,428	1,287	1,428
EG003	Nivolumab Monotherapy (Total)	All Participants that received nivolumab administered intravenously at 3 mg/kg every two weeks regardless of continuation or discontinuation of treatment.	1,180	1,428	918	1,428	1,306	1,428

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk EG00212 affected1,428 at risk EG00313 affected1,428 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0027 affected1,428 at risk EG003
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0025 affected1,428 at risk EG003
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0025 affected1,428 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0022 affected1,428 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG00212 affected1,428 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Atrial thrombosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0024 affected1,428 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0029 affected1,428 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0026 affected1,428 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0027 affected1,428 at risk EG003
Palpitations	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG00211 affected1,428 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0025 affected1,428 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Vestibular disorder	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Hypercalcaemia of malignancy	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Ocular myasthenia	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Vision blurred	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG00217 affected1,428 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected127 at risk EG0010 affected125 at risk EG0027 affected1,428 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0028 affected1,428 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG00213 affected1,428 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0028 affected1,428 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Enterocolonic fistula	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Gastrointestinal angiectasia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0026 affected1,428 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0024 affected1,428 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG00212 affected1,428 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Oesophageal fistula	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0021 affected1,428 at risk EG003
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG0024 affected1,428 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG0029 affected1,428 at risk EG003
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0028 affected1,428 at risk EG003
Catheter site injury	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0024 affected1,428 at risk EG003
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG00214 affected1,428 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0029 affected1,428 at risk EG003
General physical health deterioration	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Generalised oedema	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Infusion site extravasation	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Localised oedema	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Malaise	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG00215 affected1,428 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Physical deconditioning	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0012 affected125 at risk EG0028 affected1,428 at risk EG003
Sudden death	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Autoimmune cholangitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0023 affected1,428 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Abscess intestinal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Abscess oral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected127 at risk EG0011 affected125 at risk EG0024 affected1,428 at risk EG003
Catheter site cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0021 affected1,428 at risk EG003
Cryptococcosis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Device related infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Empyema	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Enterobacter pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Enterococcal infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Groin infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Influenza	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Large intestine infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Meningitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Otitis media	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Papilloma viral infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pleural infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pneumococcal sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00017 affected127 at risk EG0017 affected125 at risk EG002118 affected1,428 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0028 affected1,428 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Pneumonia haemophilus	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pneumonia necrotising	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pneumonia pseudomonal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0023 affected1,428 at risk EG003
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected127 at risk EG0012 affected125 at risk EG00222 affected1,428 at risk EG003
Septic shock	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG0023 affected1,428 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0028 affected1,428 at risk EG003
Urosepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Vascular device infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Wound infection staphylococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0024 affected1,428 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0025 affected1,428 at risk EG003
Ilium fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Product administration error	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Brain natriuretic peptide increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Influenza A virus test positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
International normalised ratio increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Staphylococcus test positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Troponin I increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Troponin increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected127 at risk EG0010 affected125 at risk EG00233 affected1,428 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0028 affected1,428 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0029 affected1,428 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0025 affected1,428 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected127 at risk EG0011 affected125 at risk EG0028 affected1,428 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0026 affected1,428 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG00211 affected1,428 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0026 affected1,428 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0029 affected1,428 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0025 affected1,428 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0025 affected1,428 at risk EG003
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0027 affected1,428 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG00011 affected127 at risk EG00115 affected125 at risk EG002509 affected1,428 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0026 affected1,428 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0029 affected1,428 at risk EG003
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0026 affected1,428 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Respiratory papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Second primary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Amnesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Aphasia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Brain oedema	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Central nervous system haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cerebellar stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0029 affected1,428 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Dyskinesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Lacunar stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Lethargy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Presyncope	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected127 at risk EG0011 affected125 at risk EG00212 affected1,428 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0029 affected1,428 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Syncope	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG0029 affected1,428 at risk EG003
Vocal cord paralysis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Device malfunction	Product Issues	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG00211 affected1,428 at risk EG003
Delirium	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0023 affected1,428 at risk EG003
Depression	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0029 affected1,428 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG00215 affected1,428 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0024 affected1,428 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Adnexal torsion	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk EG00218 affected1,428 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0023 affected1,428 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0021 affected1,428 at risk EG003
Bronchial fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected125 at risk EG0020 affected1,428 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected127 at risk EG0017 affected125 at risk EG00227 affected1,428 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0025 affected1,428 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG00291 affected1,428 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG00210 affected1,428 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG00216 affected1,428 at risk EG003
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Lung opacity	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0012 affected125 at risk EG00237 affected1,428 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG00223 affected1,428 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG00210 affected1,428 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected127 at risk EG0011 affected125 at risk EG00240 affected1,428 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0022 affected1,428 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0024 affected1,428 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected125 at risk EG00222 affected1,428 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG0020 affected1,428 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected125 at risk EG00216 affected1,428 at risk EG003
Embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0027 affected1,428 at risk EG003
Haematoma	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0021 affected1,428 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Hypertensive urgency	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0027 affected1,428 at risk EG003
Jugular vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected125 at risk EG0020 affected1,428 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0022 affected1,428 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0021 affected1,428 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected125 at risk EG0024 affected1,428 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected127 at risk EG0017 affected125 at risk EG002208 affected1,428 at risk EG003222 affected1,428 at risk
Hypothyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected127 at risk EG0014 affected125 at risk EG002129 affected1,428 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00014 affected127 at risk EG0017 affected125 at risk EG002117 affected1,428 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0009 affected127 at risk EG0016 affected125 at risk EG002274 affected1,428 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00036 affected127 at risk EG00117 affected125 at risk EG002275 affected1,428 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00022 affected127 at risk EG0019 affected125 at risk EG002332 affected1,428 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00015 affected127 at risk EG0015 affected125 at risk EG002191 affected1,428 at risk EG003
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected127 at risk EG0010 affected125 at risk EG00273 affected1,428 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG00026 affected127 at risk EG00117 affected125 at risk EG002516 affected1,428 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected127 at risk EG0013 affected125 at risk EG00284 affected1,428 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG00013 affected127 at risk EG0019 affected125 at risk EG002180 affected1,428 at risk EG003
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG00016 affected127 at risk EG0012 affected125 at risk EG002123 affected1,428 at risk EG003
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00014 affected127 at risk EG0015 affected125 at risk EG00250 affected1,428 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00015 affected127 at risk EG00114 affected125 at risk EG00289 affected1,428 at risk EG003
Sinusitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0008 affected127 at risk EG0014 affected125 at risk EG00259 affected1,428 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00028 affected127 at risk EG00115 affected125 at risk EG002128 affected1,428 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00012 affected127 at risk EG00111 affected125 at risk EG00260 affected1,428 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG00011 affected127 at risk EG00110 affected125 at risk EG00254 affected1,428 at risk EG003
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00017 affected127 at risk EG0014 affected125 at risk EG00265 affected1,428 at risk EG003
Weight decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG00012 affected127 at risk EG00120 affected125 at risk EG002182 affected1,428 at risk EG003
Weight increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00015 affected127 at risk EG0014 affected125 at risk EG00239 affected1,428 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00018 affected127 at risk EG00113 affected125 at risk EG002313 affected1,428 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0009 affected127 at risk EG0013 affected125 at risk EG002127 affected1,428 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected127 at risk EG0014 affected125 at risk EG00261 affected1,428 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00016 affected127 at risk EG0019 affected125 at risk EG002126 affected1,428 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00014 affected127 at risk EG0018 affected125 at risk EG002149 affected1,428 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected127 at risk EG0015 affected125 at risk EG00297 affected1,428 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00030 affected127 at risk EG00118 affected125 at risk EG002284 affected1,428 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00017 affected127 at risk EG00111 affected125 at risk EG002189 affected1,428 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected127 at risk EG0014 affected125 at risk EG00244 affected1,428 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected127 at risk EG0018 affected125 at risk EG00274 affected1,428 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0009 affected127 at risk EG0012 affected125 at risk EG00290 affected1,428 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected127 at risk EG0016 affected125 at risk EG00260 affected1,428 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected127 at risk EG0017 affected125 at risk EG00244 affected1,428 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00012 affected127 at risk EG0018 affected125 at risk EG002101 affected1,428 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00017 affected127 at risk EG0017 affected125 at risk EG002140 affected1,428 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00017 affected127 at risk EG0018 affected125 at risk EG002140 affected1,428 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected127 at risk EG0013 affected125 at risk EG00296 affected1,428 at risk EG003
Depression	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected127 at risk EG0015 affected125 at risk EG00271 affected1,428 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG00015 affected127 at risk EG0017 affected125 at risk EG002128 affected1,428 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00012 affected127 at risk EG0019 affected125 at risk EG00241 affected1,428 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00027 affected127 at risk EG00122 affected125 at risk EG002302 affected1,428 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00014 affected127 at risk EG00117 affected125 at risk EG002339 affected1,428 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected127 at risk EG0018 affected125 at risk EG00282 affected1,428 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected127 at risk EG0014 affected125 at risk EG00249 affected1,428 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected127 at risk EG0011 affected125 at risk EG00251 affected1,428 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00010 affected127 at risk EG0014 affected125 at risk EG00233 affected1,428 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected127 at risk EG0017 affected125 at risk EG00294 affected1,428 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected127 at risk EG0013 affected125 at risk EG00221 affected1,428 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected127 at risk EG0015 affected125 at risk EG00271 affected1,428 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG00012 affected127 at risk EG0015 affected125 at risk EG002119 affected1,428 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG00010 affected127 at risk EG0015 affected125 at risk EG00298 affected1,428 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected127 at risk EG0014 affected125 at risk EG00262 affected1,428 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected127 at risk EG0010 affected125 at risk EG00237 affected1,428 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00012 affected127 at risk EG0016 affected125 at risk EG00256 affected1,428 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected127 at risk EG0015 affected125 at risk EG00270 affected1,428 at risk EG003

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins