Controlled Comparison of Two Moxifloxacin Containing Trea... | NCT00864383

ID	Type	Description	Link
ISRCTN85595810

Status Module

Name	Class
European and Developing Countries Clinical Trials Partnership (EDCTP)	OTHER_GOV
University College, London	OTHER
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma	INDUSTRY

Description Module

Detailed Description

The current recommended treatments for tuberculosis (TB) require a patient to take multiple drugs for six to eight months. Because the course of therapy is long, many patients do not adhere to treatment and as a consequence they have a poor outcome. In these cases either the sputum is not cleared of the bacteria causing tuberculosis, or the disease returns again (called relapse). Response to medication can be monitored during treatment by collecting regular sputum samples and examining these samples by culture, for the organisms that cause tuberculosis.

The commonly used drugs to treat tuberculosis are rifampicin, isoniazid, ethambutol and pyrazinamide. Previous studies in animals and in humans suggest that a new drug called moxifloxacin may also be an effective treatment in tuberculosis. Moreover, promising laboratory studies on mice suggest that moxifloxacin may enable the total duration of chemotherapy to be reduced to four months, which would be a significant improvement for patients taking medication for tuberculosis.

This study will involve comparisons that are designed to assess whether substituting moxifloxacin for individual drugs in existing treatment combinations will enable tuberculosis treatment to be shortened. Patients selected for the study will be allocated to one of three treatment groups. The first group will be given six months standard treatment. A second group will receive moxifloxacin substituted for ethambutol, as part of a four month regimen, to see whether the shorter treatment is not inferior to the standard six month treatment. The third group will receive moxifloxacin substituted for isoniazid, as part of a four month regimen, to see whether the shorter treatment is not inferior to the standard six month treatment.

Hypotheses:

In treatment-naïve adults with active pulmonary TB treated with eight weeks of moxifloxacin (M), isoniazid (H), rifampicin (R) and pyrazinamide (Z) (i.e. a standard regimen where moxifloxacin is substituted for ethambutol (E)), followed by nine weeks of moxifloxacin, isoniazid and rifampicin, followed by nine weeks of placebo, the proportion of patients who experience treatment failure or disease relapse in the twelve months following treatment completion will not be inferior to that observed in patients who are treated with a standard regimen (eight weeks of ethambutol, isoniazid, rifampicin and pyrazinamide followed by eighteen weeks of isoniazid plus rifampicin) (Comparison 1).
In treatment-naïve adults with active pulmonary TB treated with eight weeks of ethambutol, moxifloxacin, rifampicin and pyrazinamide (i.e. a standard regimen where moxifloxacin is substituted for isoniazid), followed by nine weeks of moxifloxacin and rifampicin followed by nine weeks of placebo, the proportion of patients who experience treatment failure or disease relapse in the twelve months following treatment completion will not be inferior to that observed in patients who are treated with a standard regimen (eight weeks of ethambutol, isoniazid, rifampicin and pyrazinamide followed by eighteen weeks of isoniazid plus rifampicin) (Comparison 2).

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regimen 1 - 2EHRZ/4HR (control regimen)	Placebo Comparator	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only.	Drug: Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin
Regimen 2 - 2MHRZ/2MHR	Experimental	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo.	Drug: Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin
Regimen 3 - 2EMRZ/2MR	Experimental	Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo	Drug: Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin	Drug	Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).	The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.	18 months (within one year of completion of therapy)
Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)	The number of participants includes all patients who had at least one grade 3 or 4 adverse event.	18 months (within one year of completion of therapy)

Secondary Outcomes

Measure	Description	Time Frame
Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).	The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity.
Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.
Aged 18 years or over.
No previous anti-tuberculosis chemotherapy.
A firm home address that is readily accessible for visiting and willingness to inform the study team of any change of address during the treatment and follow-up period.
Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 & 2).
Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.
Laboratory parameters performed up to 14 days before enrolment.
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) activity less than 3 times the upper limit of normal.
- Serum total bilirubin level less than 2.5 times upper limit of normal. Creatinine clearance (CrCl) level greater than 30 mls/min.
- Haemoglobin level of at least 7.0 g/dL.
- Platelet count of at least 50x109cells/L.
- Serum potassium greater than 3.5 mmol/L.
Negative pregnancy test (women of childbearing potential).

Exclusion Criteria:

Unable to take oral medication.
Previously enrolled in this study.
Received any investigational drug in the past 3 months.
Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
Any condition that may prove fatal during the first two months of the study period.
TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome
Pre-existing non-tuberculosis disease e.g. diabetes, liver or kidney disease, blood disorders,peripheral neuritis, chronic diarrhoeal disease in which the current clinical condition of the patient is likely to prejudice the response to, or assessment of treatment.
Pregnant or breast feeding.
Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.
Contraindications to any medications in the study regimens.
Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine).
Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones.
Patients already receiving anti-retroviral therapy.
Patients whose initial isolate is shown to be multiple drug resistant (i.e. resistant to rifampicin and isoniazid) or monoresistant to rifampicin, or resistant to any fluoroquinolone)
Weight less than 35kg
HIV infection with CD4 count less than 250 cells/µL.
End stage liver failure (class Child-Pugh C).

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Stephen H Gillespie, MB BCh BAO MD DSc	University of St Andrews	Study Director
Andrew Nunn, BSc MSc	MRC Clinical Trials Unit	Principal Investigator
Sarah K Meredith, MB BS MSc	MRC Clinical Trials Unit	Principal Investigator
Timothy D McHugh, BSc PhD CSi	Centre for Medical Microbiology, Royal Free and University College Medical School	Principal Investigator
Ali Zumla, BSc MBChB MSc PhD	Centre for International Health, Royal Free and University College Medical School	Principal Investigator
Alexander Pym, MB BMRCP PhD	Unit for Clinical & Biomedical TB Research, MRC Durban	Principal Investigator
Peter Mwaba, MB ChB MMed PhD	University Teaching Hospital	Principal Investigator
Noel Sam, MMed MD	Kilimanjaro Christian Medical Centre	Principal Investigator
Andreas Diacon, BM MD	Tiervlei Trial Center and University of Stellenbosch

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tuberculosis and Thoracic Tumor Research Institute		Beijing		101149	China
Shanghai Pulmonary Hospital

PubMed Identifier	Type	Citation	Retractions
24461758	Background	Bryant JM, Harris SR, Parkhill J, Dawson R, Diacon AH, van Helden P, Pym A, Mahayiddin AA, Chuchottaworn C, Sanne IM, Louw C, Boeree MJ, Hoelscher M, McHugh TD, Bateson AL, Hunt RD, Mwaigwisya S, Wright L, Gillespie SH, Bentley SD. Whole-genome sequencing to establish relapse or re-infection with Mycobacterium tuberculosis: a retrospective observational study. Lancet Respir Med. 2013 Dec;1(10):786-92. doi: 10.1016/S2213-2600(13)70231-5. Epub 2013 Nov 21.
24429244

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
BG001	Regimen 2 - 2MHRZ/2MHR (Isoniazid)	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
BG002	Regimen 3 - 2EMRZ/2MR (Ethambutol)	Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

< 25 years

Title	Measurements
	BG000160 BG001162 BG002146 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000154 BG001163 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Black

Title	Measurements
	BG000238 BG001210 BG002

Weight group

Number

participants

Title

Denominators

Categories

< 40 kg

Title	Measurements
	BG00050 BG00144 BG002

Smoking status

Number

participants

Title

Denominators

Categories

Never

Title	Measurements
	BG000246 BG001231 BG002

HIV positivity

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG00038 BG00137 BG002

Drug resistance

Number

participants

Title

Denominators

Categories

Isoniazid

Title	Measurements
	BG00029 BG00134 BG002

Cavitation

Chest cavitation based on blinded assessment of the chest radiograph.

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG000368 BG001357 BG002

Time to positivity on MGIT sputum culture

Mycobacteria Growth Indicator Tube (MGIT) was used for the detection of mycobacteria.

Number

participants

Title

Denominators

Categories

≥ 5 days

Title	Measurements
	BG000266 BG001263 BG002

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

Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).

The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.

Per protocol population

Posted

Number

participants with failure or relapse

18 months (within one year of completion of therapy)

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG001	Regimen 2 - 2MHRZ/2MHR	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG002	Regimen 3 - 2EMRZ/2MR	Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Units	Counts
Participants	OG000510 OG001514 OG002524

Title

Denominators

Categories

Title	Measurements
	OG00043 OG00178 OG002105

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Adjusted difference in proportions	6.1			2-Sided	97.5	1.7	10.5			Adjusted difference from control in proportion of unfavorable outcome - percentage points		Non-Inferiority or Equivalence	Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the difference in proportion of patients with an unfavorable outcome.

Primary

Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)

The number of participants includes all patients who had at least one grade 3 or 4 adverse event.

Safety population, defined as all subjects who underwent randomization and who received at least on dose of study drug.

Posted

Number

participants with Grade 3 or 4 AEs

18 months (within one year of completion of therapy)

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG001	Regimen 2 - 2MHRZ/2MHR	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Secondary

Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).

The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis.

Per protocol population

Posted

Number

participants with failure or relapse

18 months (within one year of completion of therapy)

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Secondary

Number of Patients Who Are Culture Negative (Solid LJ Culture)

Number of patients who are TB LJ culture negative at 8 weeks.

Per protocol

Posted

Number

participants who are culture negative

8 weeks

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG001	Regimen 2 - 2MHRZ/2MHR	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Secondary

Number of Patients Who Are Culture Negative (Liquid MGIT Culture)

Number of patients who are TB MGIT culture negative at 8 weeks.

Posted

Number

participants who are culture negative

8 weeks

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG001	Regimen 2 - 2MHRZ/2MHR	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Secondary

Time to First Culture Negative Sputum Sample (LJ Solid Media)

Culture negative for TB using LJ cultures.

All randomized patients excluding late screen failures

Posted

Median

95% Confidence Interval

Time to culture negative status / weeks

18 months

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG001	Regimen 2 - 2MHRZ/2MHR	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Secondary

Time to First Culture Negative Sputum Sample (MGIT Liquid Media)

All randomized patients excluding late screen failures

Posted

Median

95% Confidence Interval

Time to culture negative status / weeks

18 months

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG001	Regimen 2 - 2MHRZ/2MHR	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Secondary

Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media.

Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Unfavorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result ("isolated positive culture") was followed by at least two negative culture results.

All randomized subjects.

Posted

Number

participants with unfavorable outcome

18 months

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG001

Secondary

Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media.

Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Favorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result ("isolated positive culture") was followed by at least two negative culture results.

Posted

Number

participants with unfavorable outcome

18 months

ID	Title	Description
OG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
OG001	Regimen 2 - 2MHRZ/2MHR

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Regimen 1 - 2EHRZ/4HR (Control Regimen)	Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.	38	639	507	639
EG001	Regimen 2 - 2MHRZ/2MHR	Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo. Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.	46	655	537	655
EG002	Regimen 3 - 2EMRZ/2MR	Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.	40	636	522	636

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Distension	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Abdominal Mass	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Abdominal Tenderness	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Acute Abdomen	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Ascites	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected655 at risk EG0022 events2 affected636 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Peptic Ulcer Perforation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events3 affected655 at risk EG00211 events6 affected636 at risk
Appendicitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Diarrhoea Infectious	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Disseminated Tuberculosis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Gangrene	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hepatitis B	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Blood Bilirubin Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Blood Creatinine Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Breath Sounds Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Gamma- Glutamyltransferase Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Haemoglobin Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Hepatic Enzyme Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0013 events3 affected655 at risk EG0024 events4 affected636 at risk
International Normalised Ratio Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Liver Function Test Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Prothrombin Time prolonged	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Respiratory Rate Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected639 at risk EG0012 events2 affected655 at risk EG0028 events6 affected636 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 events7 affected639 at risk EG0017 events6 affected655 at risk EG0022 events2 affected636 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events1 affected655 at risk EG0020 events0 affected636 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 events2 affected639 at risk EG0013 events3 affected655 at risk EG0026 events3 affected636 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Weight Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0024 events2 affected636 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00017 events10 affected639 at risk EG00116 events13 affected655 at risk EG00211 events8 affected636 at risk
Hypochromic Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00013 events8 affected639 at risk EG00112 events9 affected655 at risk EG00212 events9 affected636 at risk
Lymph Node Pain	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0007 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00061 events43 affected639 at risk EG00171 events44 affected655 at risk EG00268 events50 affected636 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Microcytic Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Monocytosis	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00013 events4 affected639 at risk EG0016 events3 affected655 at risk EG0025 events2 affected636 at risk
Neutrophilia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0023 events2 affected636 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Arrhythmia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Bradycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Cardiac Failure	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Congestive Cardiomyopathy	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Cor Pulmonale	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Hyperdynamic Left Ventricle	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Left Ventricular Hypertrophy	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Palpitations	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0015 events4 affected655 at risk EG0026 events2 affected636 at risk
Pericardial Disease	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00054 events40 affected639 at risk EG00171 events48 affected655 at risk EG00245 events39 affected636 at risk
Ventricular Hypertrophy	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Auricular Swelling	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Cerumen Impaction	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG00013 events10 affected639 at risk EG0017 events5 affected655 at risk EG0028 events8 affected636 at risk
Deafness	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Ear Canal Erythema	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Ear Discomfort	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0022 events1 affected636 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0014 events3 affected655 at risk EG0027 events5 affected636 at risk
Ear Pruritus	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Haematotympanum	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Hearing Impaired	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0022 events1 affected636 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Tympanic Membrane Hyperaemia	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0014 events4 affected655 at risk EG0021 events1 affected636 at risk
Tympanic Membrane Perforation	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0004 events2 affected639 at risk EG0014 events4 affected655 at risk EG0024 events3 affected636 at risk
Tympanic Membrane Scarring	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Tympanosclerosis	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0016 events4 affected655 at risk EG0022 events1 affected636 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0013 events3 affected655 at risk EG0020 events0 affected636 at risk
Astigmatism	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Cataract	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0024 events4 affected636 at risk
Conjunctival Haemorrhage	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Conjunctival Hyperaemia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Conjunctival Irritation	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Conjunctival Pallor	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events3 affected655 at risk EG0023 events3 affected636 at risk
Conjunctivitis	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0016 events4 affected655 at risk EG0023 events3 affected636 at risk
Conjunctivitis Allergic	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0012 events2 affected655 at risk EG0023 events3 affected636 at risk
Corneal Opacity	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Dry Eye	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Eye Irritation	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0022 events2 affected636 at risk
Eye Oedema	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Eye Pain	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected639 at risk EG0012 events2 affected655 at risk EG0024 events4 affected636 at risk
Eye Pruritus	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected639 at risk EG0016 events5 affected655 at risk EG0029 events8 affected636 at risk
Eyelid Oedema	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Eyelids Pruritus	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Hypermetropia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Keratitis	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Lacrimation Increased	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0022 events2 affected636 at risk
Night Blindness	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Ocular Discomfort	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Ocular Hyperaemia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0023 events2 affected636 at risk
Ocular Icterus	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0021 events1 affected636 at risk
Photophobia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0021 events1 affected636 at risk
Pterygium	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Scleral Hyperaemia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Scleritis	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Uveitis	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events1 affected655 at risk EG0020 events0 affected636 at risk
Vision Blurred	Eye disorders	MedDRA 16.1	Systematic Assessment	EG00012 events10 affected639 at risk EG0018 events8 affected655 at risk EG0029 events9 affected636 at risk
Visual Acuity Reduced	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0009 events7 affected639 at risk EG00118 events16 affected655 at risk EG00212 events12 affected636 at risk
Visual Impairment	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected639 at risk EG0013 events3 affected655 at risk EG0022 events1 affected636 at risk
Vitreous Floaters	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0016 events5 affected655 at risk EG0028 events7 affected636 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0013 events2 affected655 at risk EG0024 events4 affected636 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00017 events12 affected639 at risk EG00120 events15 affected655 at risk EG00217 events15 affected636 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00010 events10 affected639 at risk EG00114 events14 affected655 at risk EG0028 events7 affected636 at risk
Abdominal Rigidity	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Abdominal Tenderness	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected639 at risk EG00113 events9 affected655 at risk EG0028 events6 affected636 at risk
Anal Haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Anal Pruritus	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Ascites	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Chapped Lips	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0021 events1 affected636 at risk
Colitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00011 events10 affected639 at risk EG00117 events12 affected655 at risk EG0023 events3 affected636 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 events6 affected639 at risk EG0011 events1 affected655 at risk EG0029 events7 affected636 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00018 events16 affected639 at risk EG00151 events38 affected655 at risk EG00259 events46 affected636 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00013 events10 affected639 at risk EG0018 events8 affected655 at risk EG0026 events5 affected636 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Epigastric Discomfort	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0011 events1 affected655 at risk EG0022 events2 affected636 at risk
Faecal Volume Increased	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Flatulence	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events1 affected655 at risk EG0020 events0 affected636 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Frequent Bowel Movements	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Gastritis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected639 at risk EG0017 events7 affected655 at risk EG0024 events3 affected636 at risk
Gastrointestinal Hypermotility	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Gastrointestinal Pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Gastrointestinal Sounds Abnormal	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Gingival Pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Gingival Recession	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Glossitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0023 events2 affected636 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected639 at risk EG0011 events1 affected655 at risk EG0023 events3 affected636 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0013 events3 affected655 at risk EG0020 events0 affected636 at risk
Lip Blister	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Lip Swelling	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Lip Ulceration	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Melaena	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00049 events40 affected639 at risk EG00144 events39 affected655 at risk EG00250 events45 affected636 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0023 events2 affected636 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Oral Mucosal Discolouration	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Oral Pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Paraesthesia Oral	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Parotid Gland Enlargement	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Post-Tussive Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0015 events4 affected655 at risk EG0022 events1 affected636 at risk
Rectal Discharge	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Rectal Tenesmus	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Salivary Gland Disorder	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Salivary Gland Pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Tongue Coated	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Tongue Disorder	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Tongue Haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Tongue Ulceration	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Toothache	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0007 events5 affected639 at risk EG0016 events5 affected655 at risk EG0024 events4 affected636 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00056 events44 affected639 at risk EG00195 events70 affected655 at risk EG00292 events70 affected636 at risk
Adhesion	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment	EG00014 events12 affected639 at risk EG00111 events10 affected655 at risk EG00219 events16 affected636 at risk
Catheter Site Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Chest Discomfort	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0014 events4 affected655 at risk EG0021 events1 affected636 at risk
Chest Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG00076 events60 affected639 at risk EG00157 events49 affected655 at risk EG00268 events55 affected636 at risk
Chills	General disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Crepitations	General disorders	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected639 at risk EG0014 events4 affected655 at risk EG0028 events7 affected636 at risk
Face Oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG00012 events10 affected639 at risk EG00122 events21 affected655 at risk EG0027 events7 affected636 at risk
Gait Disturbance	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Generalised Oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Hernia	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Hypothermia	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Influenza Like Illness	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Local Swelling	General disorders	MedDRA 16.1	Systematic Assessment	EG0007 events5 affected639 at risk EG00110 events9 affected655 at risk EG0022 events2 affected636 at risk
Malaise	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0013 events3 affected655 at risk EG0023 events3 affected636 at risk
Mass	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Medical Device Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Mucosal Discolouration	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG00022 events20 affected639 at risk EG00120 events18 affected655 at risk EG00230 events23 affected636 at risk
Oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Oedema Peripheral	General disorders	MedDRA 16.1	Systematic Assessment	EG0007 events6 affected639 at risk EG0013 events2 affected655 at risk EG0024 events2 affected636 at risk
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG00012 events10 affected639 at risk EG00114 events9 affected655 at risk EG00217 events10 affected636 at risk
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG00095 events58 affected639 at risk EG001103 events67 affected655 at risk EG002116 events84 affected636 at risk
Tenderness	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Thirst	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Unevaluable Event	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Xerosis	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG00010 events5 affected639 at risk EG0013 events2 affected655 at risk EG0022 events2 affected636 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0023 events2 affected636 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0017 events5 affected655 at risk EG0023 events2 affected636 at risk
Jaundice	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Liver Tenderness	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0022 events1 affected636 at risk
Abscess Neck	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Acarodermatitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0012 events1 affected655 at risk EG0021 events1 affected636 at risk
Amoebic Dysentery	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Anal Abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Body Tinea	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0015 events5 affected655 at risk EG0024 events3 affected636 at risk
Breast Abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Bronchitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00010 events10 affected639 at risk EG0013 events3 affected655 at risk EG0026 events6 affected636 at risk
Bronchitis Bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Bronchitis Viral	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Candida Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Chest Wall Abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Cystitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Dermatitis Infected	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Dysentery	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Ear Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Eye Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Febrile Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Folliculitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Fungal Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0012 events2 affected655 at risk EG0022 events2 affected636 at risk
Fungal Skin Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0007 events5 affected639 at risk EG0013 events3 affected655 at risk EG0025 events3 affected636 at risk
Furuncle	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected655 at risk EG0023 events2 affected636 at risk
Gastroenteritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected639 at risk EG0011 events1 affected655 at risk EG00214 events13 affected636 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Genital Candidiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Genital Herpes	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Giardiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Gingival Abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Helminthic Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0012 events2 affected655 at risk EG0022 events2 affected636 at risk
Herpes Zoster	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0015 events4 affected655 at risk EG0021 events1 affected636 at risk
Hiv Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Impetigo	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Infected Dermal Cyst	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00016 events15 affected639 at risk EG00116 events16 affected655 at risk EG00222 events17 affected636 at risk
Laryngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0011 events1 affected655 at risk EG0023 events3 affected636 at risk
Lobar Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0023 events3 affected636 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected639 at risk EG00111 events10 affected655 at risk EG0024 events4 affected636 at risk
Lower Respiratory Tract Infection Bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Lung Abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Lung Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Malaria	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00015 events15 affected639 at risk EG00111 events10 affected655 at risk EG00210 events9 affected636 at risk
Molluscum Contagiosum	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Mycobacterium Fortuitum Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Myringitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00014 events12 affected639 at risk EG00116 events15 affected655 at risk EG00221 events20 affected636 at risk
Oesophageal Candidiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Onychomycosis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Ophthalmic Herpes Zoster	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Oral Candidiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0009 events6 affected639 at risk EG00114 events12 affected655 at risk EG00213 events11 affected636 at risk
Oral Hairy Leukoplakia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Oral Herpes	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Otitis Externa	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Otitis Media	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Otitis Media Chronic	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Pelvic Inflammatory Disease	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events1 affected655 at risk EG0021 events1 affected636 at risk
Pericarditis Tuberculous	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Pharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0018 events7 affected655 at risk EG0027 events7 affected636 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Pneumocystis Jirovecii Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0009 events6 affected639 at risk EG0015 events3 affected655 at risk EG0027 events7 affected636 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Pneumonia Haemophilus	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00014 events14 affected639 at risk EG00127 events24 affected655 at risk EG00237 events36 affected636 at risk
Pulpitis Dental	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Pyelonephritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Rash Pustular	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0024 events2 affected636 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events2 affected655 at risk EG0023 events3 affected636 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Rhinitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00011 events10 affected639 at risk EG00116 events13 affected655 at risk EG00221 events18 affected636 at risk
Schistosomiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Schistosomiasis Bladder	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Septic Rash	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0028 events1 affected636 at risk
Sinusitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0023 events2 affected636 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Tinea Capitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0015 events4 affected655 at risk EG0020 events0 affected636 at risk
Tinea Faciei	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Tinea Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Tinea Pedis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0024 events3 affected636 at risk
Tinea Versicolour	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events3 affected655 at risk EG0025 events4 affected636 at risk
Tonsillitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Tooth Abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0012 events2 affected655 at risk EG0022 events1 affected636 at risk
Tooth Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Tuberculosis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG00111 events11 affected655 at risk EG0029 events8 affected636 at risk
Tuberculosis Gastrointestinal	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Typhoid Fever	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00027 events24 affected639 at risk EG00123 events20 affected655 at risk EG00224 events20 affected636 at risk
Upper Respiratory Tract Infection Bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0009 events8 affected639 at risk EG0018 events7 affected655 at risk EG00212 events11 affected636 at risk
Vaginitis Bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Varicella	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Viral Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00013 events7 affected639 at risk EG00111 events6 affected655 at risk EG00211 events7 affected636 at risk
Vulvovaginal Candidiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0008 events5 affected639 at risk EG0019 events7 affected655 at risk EG0028 events6 affected636 at risk
Vulvovaginitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Wound Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Wound Sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Animal Bite	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0011 events1 affected655 at risk EG0024 events4 affected636 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0022 events2 affected636 at risk
Eyelid Injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Fibula Fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Foreign Body	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Foreign Body In Eye	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Human Bite	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Incorrect Dose Administered	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Injury Corneal	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Jaw Fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0025 events4 affected636 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0014 events2 affected655 at risk EG0022 events2 affected636 at risk
Lip Injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events3 affected655 at risk EG0021 events1 affected636 at risk
Periorbital Contusion	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Skeletal Injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Soft Tissue Injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0023 events3 affected636 at risk
Stab Wound	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0021 events1 affected636 at risk
Activated Partial Thromboplastin Time Prolonged	Investigations	MedDRA 16.1	Systematic Assessment	EG00013 events10 affected639 at risk EG00113 events10 affected655 at risk EG00216 events13 affected636 at risk
Alanine Aminotransferase Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Alanine Aminotransferase Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG00037 events25 affected639 at risk EG00139 events30 affected655 at risk EG00224 events16 affected636 at risk
Amylase Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG00041 events28 affected639 at risk EG00147 events35 affected655 at risk EG00231 events24 affected636 at risk
Blood Albumin Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 events1 affected639 at risk EG0013 events2 affected655 at risk EG0022 events2 affected636 at risk
Blood Bilirubin Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected639 at risk EG00114 events9 affected655 at risk EG0026 events2 affected636 at risk
Blood Creatine Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Blood Creatinine Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Blood Creatinine Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0008 events7 affected639 at risk EG00117 events15 affected655 at risk EG00210 events7 affected636 at risk
Blood Glucose Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Blood Glucose Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 events2 affected639 at risk EG0019 events3 affected655 at risk EG0020 events0 affected636 at risk
Blood Potassium Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events3 affected655 at risk EG0025 events4 affected636 at risk
Blood Potassium Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Blood Pressure Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Blood Pressure Diastolic Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Blood Pressure Diastolic Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Blood Pressure Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0007 events6 affected639 at risk EG0017 events6 affected655 at risk EG0028 events7 affected636 at risk
Blood Pressure Systolic Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0022 events2 affected636 at risk
Blood Pressure Systolic Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0014 events1 affected655 at risk EG0020 events0 affected636 at risk
Blood Sodium Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0009 events4 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Blood Sodium Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0025 events4 affected636 at risk
Blood Urea Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Blood Uric Acid Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Body Temperature Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Breath Sounds Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0009 events7 affected639 at risk EG00110 events9 affected655 at risk EG0026 events5 affected636 at risk
Cardiac Murmur	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Cd4 Lymphocytes Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Chest X-Ray Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Coagulation Test Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Colour Vision Tests Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Creatinine Renal Clearance Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 events2 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Gastrointestinal Examination Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Glucose Urine Present	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Haemoglobin Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG00024 events13 affected639 at risk EG00129 events18 affected655 at risk EG00228 events20 affected636 at risk
Heart Rate Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Heart Rate Irregular	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0011 events1 affected655 at risk EG0023 events1 affected636 at risk
Heart Sounds Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hepatic Enzyme Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Hepatic Enzyme Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG00036 events22 affected639 at risk EG00130 events18 affected655 at risk EG00217 events11 affected636 at risk
International Normalised Ratio Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
International Normalised Ratio Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Liver Function Test Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Liver Palpable Subcostal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Lymph Node Palpable	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Neutrophil Count Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events3 affected655 at risk EG0020 events0 affected636 at risk
Neutrophil Percentage Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Ophthalmological Examination Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Percussion Test Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Platelet Count Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected639 at risk EG0016 events3 affected655 at risk EG0024 events4 affected636 at risk
Prothrombin Level Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Prothrombin Time Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Prothrombin Time Prolonged	Investigations	MedDRA 16.1	Systematic Assessment	EG00015 events11 affected639 at risk EG00116 events13 affected655 at risk EG00230 events20 affected636 at risk
Pulmonary Physical Examination Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Red Blood Cell Sedimentation Rate Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Respiratory Rate Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Transaminases Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Urine Analysis Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Urine Cytology Abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Urine Leukocyte Esterase Positive	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Weight Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG00083 events62 affected639 at risk EG00185 events70 affected655 at risk EG00277 events72 affected636 at risk
White Blood Cell Count Decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
White Blood Cell Count Increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Abnormal Loss Of Weight	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00022 events15 affected639 at risk EG00123 events20 affected655 at risk EG00218 events16 affected636 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00054 events45 affected639 at risk EG00135 events33 affected655 at risk EG00250 events45 affected636 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00010 events6 affected639 at risk EG0019 events7 affected655 at risk EG00213 events9 affected636 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0021 events1 affected636 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0016 events3 affected655 at risk EG0025 events2 affected636 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0023 events3 affected636 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0013 events1 affected655 at risk EG0021 events1 affected636 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0014 events3 affected655 at risk EG0021 events1 affected636 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected639 at risk EG0016 events5 affected655 at risk EG0021 events1 affected636 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Metabolic Acidosis	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Vitamin B Complex Deficiency	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG000182 events10 affected639 at risk EG001177 events12 affected655 at risk EG002162 events10 affected636 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0007 events6 affected639 at risk EG00112 events6 affected655 at risk EG0021 events1 affected636 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0017 events4 affected655 at risk EG0022 events2 affected636 at risk
Arthrotoxicity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0015 events3 affected655 at risk EG0027 events4 affected636 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00026 events19 affected639 at risk EG00124 events20 affected655 at risk EG00222 events20 affected636 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Chondrotoxicity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events3 affected655 at risk EG0021 events1 affected636 at risk
Clubbing	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Finger Deformity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0024 events4 affected636 at risk
Gouty Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 events2 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Joint Range Of Motion Decreased	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events2 affected655 at risk EG0021 events1 affected636 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected639 at risk EG0015 events4 affected655 at risk EG0029 events6 affected636 at risk
Ligament Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0013 events2 affected655 at risk EG0020 events0 affected636 at risk
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Muscle Atrophy	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Muscle Fatigue	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00011 events10 affected639 at risk EG00110 events6 affected655 at risk EG0024 events4 affected636 at risk
Muscle Swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected639 at risk EG0015 events5 affected655 at risk EG0022 events2 affected636 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0015 events3 affected655 at risk EG0020 events0 affected636 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Musculoskeletal Disorder	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00017 events12 affected639 at risk EG00112 events11 affected655 at risk EG0028 events7 affected636 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected639 at risk EG0016 events4 affected655 at risk EG0021 events1 affected636 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00015 events14 affected639 at risk EG00141 events28 affected655 at risk EG00225 events21 affected636 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected639 at risk EG0016 events6 affected655 at risk EG0023 events2 affected636 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00044 events32 affected639 at risk EG00138 events27 affected655 at risk EG00243 events29 affected636 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events1 affected655 at risk EG0020 events0 affected636 at risk
Sensation Of Heaviness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Spinal Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Tendon Disorder	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0016 events5 affected655 at risk EG0024 events4 affected636 at risk
Tendon Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0014 events4 affected655 at risk EG0023 events3 affected636 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0013 events2 affected655 at risk EG0021 events1 affected636 at risk
Trigger Finger	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Upper Extremity Mass	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Anogenital Warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Penile Wart	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Pharyngeal Neoplasm Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Thyroid Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Ageusia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Burning Sensation	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0013 events3 affected655 at risk EG0020 events0 affected636 at risk
Coma	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Convulsion	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00017 events15 affected639 at risk EG00125 events16 affected655 at risk EG00232 events26 affected636 at risk
Dizziness Postural	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Dysgeusia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Epilepsy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00044 events35 affected639 at risk EG00145 events39 affected655 at risk EG00263 events52 affected636 at risk
Hemiparesis	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Hemiplegia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hyperreflexia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00014 events8 affected639 at risk EG0019 events8 affected655 at risk EG00219 events12 affected636 at risk
Lethargy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0023 events3 affected636 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Memory Impairment	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Migraine	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Neuralgia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Neuritis	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00016 events13 affected639 at risk EG0016 events6 affected655 at risk EG00214 events11 affected636 at risk
Paraesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00012 events8 affected639 at risk EG00113 events10 affected655 at risk EG0025 events3 affected636 at risk
Parosmia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Post Herpetic Neuralgia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Sciatica	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0023 events2 affected636 at risk
Sensory Disturbance	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Somnolence	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0006 events6 affected639 at risk EG0018 events5 affected655 at risk EG0027 events7 affected636 at risk
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0022 events2 affected636 at risk
Tension Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Tremor	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Visual Field Defect	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Abortion Threatened	Pregnancy, puerperium and perinatal conditions	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0014 events4 affected655 at risk EG0020 events0 affected636 at risk
Anxiety	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0025 events5 affected636 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Confusional State	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0023 events2 affected636 at risk
Depression	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Hallucination	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Initial Insomnia	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Insomnia	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG00016 events12 affected639 at risk EG0016 events6 affected655 at risk EG0026 events6 affected636 at risk
Nervousness	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Premature Ejaculation	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Sleep Disorder	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Tension	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Bilirubinuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0015 events5 affected655 at risk EG0020 events0 affected636 at risk
Dysuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0007 events6 affected639 at risk EG0015 events5 affected655 at risk EG0022 events2 affected636 at risk
Enuresis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Glycosuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0025 events3 affected636 at risk
Haematuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0013 events3 affected655 at risk EG0026 events4 affected636 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0014 events4 affected655 at risk EG0021 events1 affected636 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Nocturia	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Polyuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Proteinuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0016 events6 affected655 at risk EG0028 events7 affected636 at risk
Renal Colic	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Urethral Discharge	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Breast Discharge	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Breast Pain	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0004 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Fibrocystic Breast Disease	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Genital Rash	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0022 events1 affected636 at risk
Genital Ulceration	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0004 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Menstruation Irregular	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Nipple Pain	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Penile Discharge	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Polymenorrhoea	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Pruritus Genital	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Testicular Pain	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Vaginal Discharge	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected655 at risk EG0021 events1 affected636 at risk
Vaginal Disorder	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Vulvovaginal Pruritus	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0014 events4 affected655 at risk EG0021 events1 affected636 at risk
Allergic Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0017 events5 affected655 at risk EG0024 events4 affected636 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG000107 events85 affected639 at risk EG001136 events11 affected655 at risk EG002188 events13 affected636 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0013 events3 affected655 at risk EG0021 events1 affected636 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00070 events49 affected639 at risk EG00167 events54 affected655 at risk EG00299 events79 affected636 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected639 at risk EG0012 events2 affected655 at risk EG0023 events2 affected636 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00059 events51 affected639 at risk EG00171 events55 affected655 at risk EG00247 events40 affected636 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 events5 affected639 at risk EG0019 events8 affected655 at risk EG0026 events5 affected636 at risk
Mediastinal Shift	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Nasal Discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Nasal Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Nasal Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Nasal Ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Obstructive Airways Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected655 at risk EG0020 events0 affected636 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 events7 affected639 at risk EG00110 events10 affected655 at risk EG00211 events11 affected636 at risk
Pharyngeal Erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0013 events3 affected655 at risk EG0024 events4 affected636 at risk
Pharyngeal Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0023 events1 affected636 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Pleural Rub	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0007 events5 affected639 at risk EG0016 events5 affected655 at risk EG00219 events18 affected636 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0014 events3 affected655 at risk EG00210 events10 affected636 at risk
Pulmonary Arterial Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0012 events2 affected655 at risk EG0021 events1 affected636 at risk
Pulmonary Hilum Mass	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00017 events11 affected639 at risk EG00111 events10 affected655 at risk EG00220 events18 affected636 at risk
Respiratory Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00058 events46 affected639 at risk EG00163 events52 affected655 at risk EG00269 events54 affected636 at risk
Respiratory Fremitus	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0014 events2 affected655 at risk EG0025 events5 affected636 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00012 events11 affected639 at risk EG0018 events7 affected655 at risk EG0025 events4 affected636 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events3 affected655 at risk EG0021 events1 affected636 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0015 events4 affected655 at risk EG0022 events2 affected636 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Tonsillar Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Tonsillar Inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00010 events6 affected639 at risk EG0018 events7 affected655 at risk EG00211 events9 affected636 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected655 at risk EG0024 events4 affected636 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Chloasma	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Dermal Cyst	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0007 events6 affected639 at risk EG0015 events4 affected655 at risk EG0023 events3 affected636 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0022 events2 affected636 at risk
Dermatitis Bullous	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Diabetic Foot	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0021 events1 affected636 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0023 events2 affected636 at risk
Exfoliative Rash	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hand Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Milia	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00032 events29 affected639 at risk EG00150 events48 affected655 at risk EG00261 events57 affected636 at risk
Pemphigus	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00046 events39 affected639 at risk EG00152 events35 affected655 at risk EG00247 events37 affected636 at risk
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00022 events18 affected639 at risk EG00120 events16 affected655 at risk EG00212 events9 affected636 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00033 events25 affected639 at risk EG00120 events18 affected655 at risk EG00232 events22 affected636 at risk
Rash Generalised	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Rash Macular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected639 at risk EG0017 events5 affected655 at risk EG0022 events2 affected636 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected639 at risk EG0014 events4 affected655 at risk EG0024 events4 affected636 at risk
Rash Maculovesicular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Rash Papular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0006 events6 affected639 at risk EG0018 events7 affected655 at risk EG00213 events8 affected636 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00012 events9 affected639 at risk EG0014 events4 affected655 at risk EG0028 events5 affected636 at risk
Seborrhoeic Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events1 affected636 at risk
Skin Discolouration	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Skin Exfoliation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected655 at risk EG0021 events1 affected636 at risk
Skin Hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 events2 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0023 events2 affected636 at risk
Skin Reaction	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0013 events2 affected655 at risk EG0021 events1 affected636 at risk
Skin Warm	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected655 at risk EG0022 events2 affected636 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0020 events0 affected636 at risk
Cosmetic Body Piercing	Social circumstances	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Physical Assault	Social circumstances	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Victim Of Crime	Social circumstances	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0022 events2 affected636 at risk
Cataract Operation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Ear Operation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Eye Prosthesis Insertion	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Finger Amputation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Leg Amputation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Tooth Extraction	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected655 at risk EG0021 events1 affected636 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0003 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Diastolic Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Haematoma	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hot Flush	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00028 events15 affected639 at risk EG00130 events18 affected655 at risk EG00216 events10 affected636 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected655 at risk EG0025 events5 affected636 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Pallor	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected639 at risk EG0014 events4 affected655 at risk EG0021 events1 affected636 at risk
Phlebitis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0021 events1 affected636 at risk
Poor Peripheral Circulation	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected655 at risk EG0020 events0 affected636 at risk
Systolic Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected655 at risk EG0022 events2 affected636 at risk
Thrombophlebitis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk
Varicose Vein	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected655 at risk EG0020 events0 affected636 at risk

ID	Term
D014376	Tuberculosis
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012141	Respiratory Tract Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005029	Ethylenediamines
D003959	Diamines
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals
D006834	Hydrazines
D007539	Isonicotinic Acids
D000147	Acids, Heterocyclic
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D011719	Pyrazines
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D047029	Lactams, Macrocyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

ID	Term
D000077266	Moxifloxacin
D004977	Ethambutol
D007538	Isoniazid
D011718	Pyrazinamide
D012293	Rifampin