Long-Term Effectiveness And Safety Of CP-690,550 For The... | NCT00413699

ID	Type	Description	Link
2006-005035-19	EudraCT Number

Label	Type	Description	Intervention Names
Open-Label Active Treatment Enrolled from Phase 2	Experimental	Patients enrolling from Phase 2 studies	Drug: CP-690,550
Open-Label Active Treatment Enrolled from Phase 3	Experimental	Patients enrolling from Phase 3 studies	Drug: CP-690,550

Name	Type	Description	Arm Group Labels	Other Names
CP-690,550	Drug	5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Measure	Description	Time Frame
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports	Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each. Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell	Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug
Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.	Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)
Extension Period: Number of Participants With Laboratory Test Abnormalities	Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:<0.8lower limit of normal (LLN), platelet<0.5LLN/>1.75upper limit of normal (ULN), white blood cell (WBC)<0.6LLN/>1.5ULN, lymphocyte, neutrophil, protein, albumin <0.8LLN/>1.2ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: >1.2ULN; bilirubin>1.5ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:>3.0ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:>1.3ULN; sodium <0.95LLN/>1.05ULN, potassium, chloride, calcium, bicarbonate: <0.9LLN/>1.1ULN; glucose<0.6LLN/>1.5ULN; Urine (specific gravity<1.003/>1.030, pH<4.5/>8, glucose, ketone, protein, blood/Hg(>=1; RBC, WBC>=20; creatinine kinase>2ULN).

Measure	Description	Time Frame
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses	The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Rheumatology Associates of North Alabama, PC

PubMed Identifier	Type	Citation	Retractions
41448717	Derived	Strand V, Schulze-Koops H, Al-Emadi S, Kinch CD, Gruben D, Germino R, Connell CA, Mysler E. Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials. BMJ Open. 2025 Dec 24;15(12):e082366. doi: 10.1136/bmjopen-2023-082366.
38883150

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
FG001	Initial Period: Tofacitinib 10 mg BID

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

Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports

Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each.

Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell

For abnormal laboratory results, those listed include both mandatory and optional laboratory tests. The number of participants analyzed is the number with at least one evaluable observation of the given laboratory test. Fasting lipids were only collected from participants who enrolled more than 14 days after last visit of their qualifying study.

Posted

Number

Number of participants

Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
OG002	Initial Period: All Tofacitinib	All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.

Units	Counts
Participants	OG0001123 OG0013358 OG0024481

Title

Denominators

Categories

Participants with non-serious AEs

- ParticipantsOG0001123
- ParticipantsOG0013358
- ParticipantsOG0024481

Title	Measurements

Primary

Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.

Posted

Count of Participants

Participants

Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)

ID	Title	Description
OG000	Extension Period: Tofacitinib 5 mg	Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.

Units	Counts

Primary

Extension Period: Number of Participants With Laboratory Test Abnormalities

Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:<0.8*lower limit of normal (LLN), platelet<0.5*LLN/>1.75*upper limit of normal (ULN), white blood cell (WBC)<0.6*LLN/>1.5*ULN, lymphocyte, neutrophil, protein, albumin <0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: >1.2*ULN; bilirubin>1.5*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN/>1.1*ULN; glucose<0.6*LLN/>1.5*ULN; Urine (specific gravity<1.003/>1.030, pH<4.5/>8, glucose, ketone, protein, blood/Hg(>=1; RBC, WBC>=20; creatinine kinase>2*ULN).

Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.

Posted

Count of Participants

Participants

Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)

ID	Title	Description
OG000	Extension Period: Tofacitinib 5 mg	Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.

Primary

Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis

Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114.

The stated number of participants analyzed is the total number of participants enrolled in each group. The number of evaluable participants is the number remaining in the study in the given time period.

Posted

Number

Number of participants

Includes AEs for every visit and up to 999 days after last dose of study drug

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
OG002	Initial Period: All Tofacitinib	All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.

Primary

Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib

Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.

Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants evaluable for specified categories.

Posted

Number

Percentage of participants

Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period

ID	Title	Description
OG000	Extension Period: Tofacitinib 5 mg	Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.

Units	Counts
Participants

Secondary

Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses

The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables.

The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Posted

Number

Percent of participants

Every visit until study completion

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
OG002	Initial Period: All Tofacitinib

Secondary

Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses

ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant's global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant's assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.

Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.

Posted

Number

Percentage of participants

Month 3, 6, 9 and 12 of Extension Period

ID	Title	Description
OG000	Extension Period: Tofacitinib 5 mg	Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.

Secondary

Initial Period: Area Under American College of Rheumatology (ACR) n Curve

No data were collected for this endpoint because it was removed from the protocol in a previous amendment.

No data were collected for this endpoint as it was removed from the protocol in a protocol amendment.

Posted

Not applicable as no data were collected for this endpoint.

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
OG002	Initial Period: All Tofacitinib	All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.

Units	Counts
Participants

Secondary

Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])

Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.

The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission.

The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Posted

Mean

Standard Deviation

Score calculated from formula

Every visit until study completion

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.

Secondary

Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12

DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of general health (GH). GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period

ID	Title	Description
OG000	Extension Period: Tofacitinib 5 mg	Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.

Secondary

Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2

Percent participants with DAS28-4 (ESR) <2.6 and ≤3.2 and percent participants with DAS28-3 (CRP) <2.6 and ≤3.2. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

Full Analysis Set - No Imputation. The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Posted

Number

Percent of participants

Every visit until study completion

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.

Secondary

Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2

DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of GH. GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score range is from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.

Posted

Number

Percentage of participants

Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period

ID	Title	Description
OG000	Extension Period: Tofacitinib 5 mg	Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.

Secondary

Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Posted

Mean

Standard Deviation

Units on scale

Every visit until study completion

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
OG002	Initial Period: All Tofacitinib	All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.

Secondary

Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12

HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. Each activity category consisted of 2-3 questionnaire. Each questionnaire was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity that required assistance from another individual or required the use of an assistive device was adjusted to a score of 2 to represent a more limited functional status. Overall score was computed as the sum of total scores divided by the number of questionnaire answered. Total possible HAQ-DI score range: 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Posted

Mean

Standard Deviation

Units on a scale

Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period

ID	Title	Description
OG000	Extension Period: Tofacitinib 5 mg	Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.

Secondary

Initial Period: Short-Form-36 Health Survey (SF-36) Score

Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were "normed" and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Posted

Mean

Standard Deviation

Scores on scale

Every visit until study completion

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.

Secondary

Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)

Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).

The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Posted

Mean

Standard Deviation

Scores on a scale

Every visit until study completion

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001

Secondary

Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study

Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

TSS=Total Sharp Score

The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Posted

Mean

Standard Deviation

Scores on a scale

Every 6 months until study completion

ID	Title	Description
OG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
OG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
OG002	Initial Period: All Tofacitinib

Secondary

Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations

Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Evaluable Immunogenicity Population

Posted

Number

95% Confidence Interval

Percent of participants

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg BID Continuous Visit 3	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted Visit 3	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
OG002	Tofacitinib 10 mg BID Continuous Visit 4	Participants receiving continuous tofacitinib treatment

Secondary

Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by ≥ 4-fold Increase in Antibody Titers

Number of participants achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Evaluable Immunogenicity Population

Posted

Number

95% Confidence Interval

Percent of participants

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg BID Continuous Visit 3	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted Visit 3	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
OG002	Tofacitinib 10 mg BID Continuous Visit 4	Participants receiving continuous tofacitinib treatment

Secondary

Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of ≥ 1:40 in ≥ 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4

Number (%) of participants achieving protective antibody titers to the seasonal influenza vaccine as measured by an HAI assay titer of ≥1:40 in ≥2 of 3 influenza antigens measured at vaccine sub-study visits 3 and 4.

The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Evaluable Immunogenicity Population

Posted

Number

95% Confidence Interval

Percent of participants

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg BID Continuous Visit 3	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted Visit 3	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
OG002	Tofacitinib 10 mg BID Continuous Visit 4	Participants receiving continuous tofacitinib treatment

Secondary

Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4

95% CI is based on Clopper-Pearson exact method for response rate.

Evaluable Immunogenicity Population

Posted

Number

95% Confidence Interval

Percent of participants

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg BID Continuous	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization

Units	Counts

Secondary

Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4

Number (%) of participants achieving a satisfactory humoral response to the seasonal influenza vaccine defined as ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2).

The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Evaluable Immunogenicity Population

Posted

Number

95% Confidence Interval

Percent of participants

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg BID Continuous Visit 4	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted Visit 4	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization

Units	Counts

Secondary

Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4

Geometric Mean Fold Increase From Baseline of Pneumococcal Antigens Measured at Visit 4.

n was the number of participants with valid and determinate assay results for the specified serotype at the given visit.

The stated number of participants analyzed was the total number of participants. The actual number of participants analyzed for some serotypes varied, and is provided where it differed from the total number of participants.

Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Evaluable Immunogenicity Population

Posted

Geometric Mean

95% Confidence Interval

Fold Change in Antibody Level

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg Continuous	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization

Secondary

Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4

Geometric Mean Fold Increase From Baseline of Influenza Antigens Measured at Visit 4.

n was the number of participants with valid and determinate assay results for the specified HAI strain at the given visit.

Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Evaluable Immunogenicity Population

Posted

Geometric Mean

95% Confidence Interval

Fold Change in Antibody Level

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg BID Continuous	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization

Units	Counts
Participants

Secondary

Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4

Mean pneumococcal concentrations (ug/mL) at vaccine baseline (visit 2) and post-vaccination visits (visits 3 and 4) by serotype. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed for each serotype varied, and is provided for each individually.

ug/mL=micrograms per milliliter

Evaluable Immunogenicity Population

Posted

Geometric Mean

95% Confidence Interval

Concentration (ug/mL)

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg BID Continuous Visit 2	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted Visit 2	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
OG002	Tofacitinib 10 mg BID Continuous Visit 3	Participants receiving continuous tofacitinib treatment
OG003	Tofacitinib 10 mg BID Interrupted Visit 3

Secondary

Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4

Mean influenza antibody titers at visits 3 and 4.

Evaluable Immunogenicity Population

Posted

Geometric Mean

95% Confidence Interval

Antibody Titer

From vaccine sub-study visit 2 (baseline) to sub-study visit 4

ID	Title	Description
OG000	Tofacitinib 10 mg BID Continuous Visit 2	Participants receiving continuous tofacitinib treatment
OG001	Tofacitinib 10 mg BID Interrupted Visit 2	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
OG002	Tofacitinib 10 mg BID Continuous Visit 3	Participants receiving continuous tofacitinib treatment
OG003	Tofacitinib 10 mg BID Interrupted Visit 3	Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
OG004

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG00110 affected3,358 at risk EG00214 affected4,481 at risk EG0030 affected48 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Mastocytosis	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Paratracheal lymphadenopathy	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Splenic infarction	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG0014 affected3,358 at risk EG0028 affected4,481 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Angina unstable	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0015 affected3,358 at risk EG0028 affected4,481 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0006 affected1,123 at risk EG00114 affected3,358 at risk EG00220 affected4,481 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bradycardia	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0015 affected3,358 at risk EG0028 affected4,481 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG0013 affected3,358 at risk EG0027 affected4,481 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0011 affected3,358 at risk EG0024 affected4,481 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cardiovascular insufficiency	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG00111 affected3,358 at risk EG00215 affected4,481 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Coronary artery thrombosis	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Long QT syndrome	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Mitral valve stenosis	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0008 affected1,123 at risk EG00113 affected3,358 at risk EG00221 affected4,481 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG0013 affected3,358 at risk EG0027 affected4,481 at risk EG003
Palpitations	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Tachycardia	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tourette's disorder	Congenital, familial and genetic disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Vestibular disorder	Ear and labyrinth disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Goitre	Endocrine disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0017 affected3,358 at risk EG00210 affected4,481 at risk EG003
Hyperparathyroidism primary	Endocrine disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Cataract	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0018 affected3,358 at risk EG00210 affected4,481 at risk EG003
Glaucoma	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Keratitis interstitial	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Necrotising retinitis	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Optic disc drusen	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Retinal artery occlusion	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Retinal detachment	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Uveitis	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0015 affected3,358 at risk EG0026 affected4,481 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0018 affected3,358 at risk EG00210 affected4,481 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0015 affected3,358 at risk EG0028 affected4,481 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Duodenal polyp	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Enterocele	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Fistula of small intestine	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastric disorder	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastric perforation	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0014 affected3,358 at risk EG0027 affected4,481 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0014 affected3,358 at risk EG0025 affected4,481 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG0014 affected3,358 at risk EG0028 affected4,481 at risk EG003
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Rectal prolapse	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Tooth disorder	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tooth impacted	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Abscess sterile	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Asthenia	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Chest discomfort	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Chest pain	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0005 affected1,123 at risk EG00112 affected3,358 at risk EG00217 affected4,481 at risk EG003
Death	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0011 affected3,358 at risk EG0024 affected4,481 at risk EG003
Drug ineffective	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Fatigue	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Fibrosis	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gait disturbance	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hernia	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0012 affected3,358 at risk EG0024 affected4,481 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Oedema	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Oedema peripheral	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Peripheral swelling	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pyrexia	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0005 affected1,123 at risk EG0015 affected3,358 at risk EG00210 affected4,481 at risk EG003
Sudden death	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0012 affected3,358 at risk EG0024 affected4,481 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cholangitis chronic	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0014 affected3,358 at risk EG0025 affected4,481 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG00010 affected1,123 at risk EG00113 affected3,358 at risk EG00223 affected4,481 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gallbladder disorder	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gallbladder non-functioning	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatic congestion	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Sphincter of Oddi dysfunction	Hepatobiliary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Allergy to arthropod bite	Immune system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Allergy to arthropod sting	Immune system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abscess limb	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Abscess neck	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Anal abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Appendicitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0006 affected1,123 at risk EG00111 affected3,358 at risk EG00217 affected4,481 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0014 affected3,358 at risk EG0025 affected4,481 at risk EG003
Arthritis infective	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Bacteraemia	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Bacterial pyelonephritis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bartholin's abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bone tuberculosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Bronchitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0015 affected3,358 at risk EG0028 affected4,481 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bursitis infective	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cellulitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG00114 affected3,358 at risk EG00216 affected4,481 at risk EG003
Cellulitis gangrenous	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Chronic tonsillitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Clostridial infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Colonic abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cytomegalovirus hepatitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Dengue fever	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Device related infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Diabetic gangrene	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Disseminated tuberculosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0014 affected3,358 at risk EG0027 affected4,481 at risk EG003
Diverticulitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0005 affected1,123 at risk EG00112 affected3,358 at risk EG00217 affected4,481 at risk EG003
Encephalitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Epstein-Barr virus infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Erysipelas	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0012 affected3,358 at risk EG0024 affected4,481 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Extradural abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Eye infection fungal	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG00113 affected3,358 at risk EG00215 affected4,481 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Groin abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
HIV infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatitis A	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatitis B	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hepatitis C	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatitis E	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Herpes dermatitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Herpes simplex	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Herpes zoster	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG00116 affected3,358 at risk EG00218 affected4,481 at risk EG003
Herpes zoster cutaneous disseminated	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Herpes zoster disseminated	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0015 affected3,358 at risk EG0025 affected4,481 at risk EG003
Herpes zoster oticus	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Incision site infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Infected seroma	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Infectious colitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Infective spondylitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Influenza	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0010 affected3,358 at risk EG0023 affected4,481 at risk EG003
Joint abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Joint tuberculosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lung infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lyme disease	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lymph node tuberculosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Meningitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Meningitis cryptococcal	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Meningococcal bacteraemia	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Meningoencephalitis bacterial	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Ophthalmic herpes simplex	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Ophthalmic herpes zoster	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Otitis media	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Peritoneal tuberculosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Peritonitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pertussis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pharyngeal abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pneumonia	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG00021 affected1,123 at risk EG00170 affected3,358 at risk EG00291 affected4,481 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Pneumonia cryptococcal	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Pneumonia necrotising	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Post procedural infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Postoperative abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0015 affected3,358 at risk EG0025 affected4,481 at risk EG003
Primary syphilis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Psoas abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0017 affected3,358 at risk EG0028 affected4,481 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0012 affected3,358 at risk EG0025 affected4,481 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0015 affected3,358 at risk EG0026 affected4,481 at risk EG003
Pyoderma streptococcal	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pyometra	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Rectal abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Renal abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Renal cyst infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0015 affected3,358 at risk EG0025 affected4,481 at risk EG003
Retinitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Salpingo-oophoritis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Secondary syphilis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Sepsis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0005 affected1,123 at risk EG0018 affected3,358 at risk EG00213 affected4,481 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Septic shock	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0014 affected3,358 at risk EG0027 affected4,481 at risk EG003
Sinusitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Sinusitis aspergillus	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Sinusitis fungal	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Skin infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Splenic abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Streptococcal infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Superinfection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tonsillitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Tooth abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Toxic shock syndrome	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tuberculosis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Tuberculosis of central nervous system	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tubo-ovarian abscess	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0008 affected1,123 at risk EG00114 affected3,358 at risk EG00222 affected4,481 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Urosepsis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Varicella zoster virus infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Viral infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Wound infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Wound infection bacterial	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Wound infection staphylococcal	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0017 affected3,358 at risk EG0029 affected4,481 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Exposure via father	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0007 affected1,123 at risk EG0019 affected3,358 at risk EG00216 affected4,481 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG0013 affected3,358 at risk EG0027 affected4,481 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG00112 affected3,358 at risk EG00214 affected4,481 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Foetal exposure during pregnancy	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0014 affected3,358 at risk EG0025 affected4,481 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Fractured ischium	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0006 affected1,123 at risk EG0012 affected3,358 at risk EG0028 affected4,481 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG00111 affected3,358 at risk EG00213 affected4,481 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0014 affected3,358 at risk EG0025 affected4,481 at risk EG003
Joint dislocation postoperative	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Maternal exposure timing unspecified	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG0013 affected3,358 at risk EG0027 affected4,481 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0015 affected3,358 at risk EG0025 affected4,481 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0015 affected3,358 at risk EG0025 affected4,481 at risk EG003
Scapula fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG00110 affected3,358 at risk EG00212 affected4,481 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0017 affected3,358 at risk EG0027 affected4,481 at risk EG003
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Twiddler's syndrome	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0014 affected3,358 at risk EG0025 affected4,481 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Airway peak pressure increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
B-lymphocyte count increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
C-reactive protein increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cardiac murmur	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Electrocardiogram T wave abnormal	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Electrocardiogram T wave inversion	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Haematocrit decreased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Haemoglobin decreased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Human papilloma virus test positive	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Liver function test increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Metamyelocyte count increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Myelocyte count increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Red blood cell sedimentation rate increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Transaminases increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Troponin I increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Weight decreased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Weight increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0016 affected3,358 at risk EG0029 affected4,481 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hypoglycaemia unawareness	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0011 affected3,358 at risk EG0024 affected4,481 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Metabolic syndrome	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Acquired claw toe	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0018 affected3,358 at risk EG0029 affected4,481 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0014 affected3,358 at risk EG0025 affected4,481 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Atlantoaxial instability	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG00113 affected3,358 at risk EG00217 affected4,481 at risk EG003
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Extraskeletal ossification	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Finger deformity	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0005 affected1,123 at risk EG00112 affected3,358 at risk EG00217 affected4,481 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hand deformity	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG00111 affected3,358 at risk EG00214 affected4,481 at risk EG003
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Joint destruction	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ligament disorder	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0005 affected1,123 at risk EG0014 affected3,358 at risk EG0029 affected4,481 at risk EG003
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG00021 affected1,123 at risk EG00163 affected3,358 at risk EG00284 affected4,481 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0015 affected3,358 at risk EG0027 affected4,481 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG00011 affected1,123 at risk EG00123 affected3,358 at risk EG00234 affected4,481 at risk EG003
Rheumatoid nodule	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0017 affected3,358 at risk EG0027 affected4,481 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0018 affected3,358 at risk EG0029 affected4,481 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0018 affected3,358 at risk EG00210 affected4,481 at risk EG003
Synovial disorder	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Tendon calcification	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
5q minus syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Acute promyelocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Adenocarcinoma of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
B-cell small lymphocytic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG00112 affected3,358 at risk EG00215 affected4,481 at risk EG003
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Benign tracheal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0004 affected1,123 at risk EG00112 affected3,358 at risk EG00216 affected4,481 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Choroid plexus papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Endometrial cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0013 affected3,358 at risk EG0025 affected4,481 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0018 affected3,358 at risk EG00211 affected4,481 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Marginal zone lymphoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Medullary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Mucoepidermoid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Nodular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0012 affected3,358 at risk EG0024 affected4,481 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Ovarian germ cell teratoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Parathyroid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0017 affected3,358 at risk EG0027 affected4,481 at risk EG003
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Sebaceous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0010 affected3,358 at risk EG0022 affected4,481 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Spindle cell sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG00110 affected3,358 at risk EG00212 affected4,481 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0012 affected3,358 at risk EG0024 affected4,481 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0014 affected3,358 at risk EG0027 affected4,481 at risk EG003
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Squamous cell carcinoma of the vulva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Synovial sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ureteral neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0007 affected1,123 at risk EG00114 affected3,358 at risk EG00221 affected4,481 at risk EG003
Vulval cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Aphasia	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Brain injury	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Brain stem infarction	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Carotid artery aneurysm	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Central nervous system lesion	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cerebellar ataxia	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cerebral arteriosclerosis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cerebral haematoma	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0014 affected3,358 at risk EG0025 affected4,481 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0016 affected3,358 at risk EG0028 affected4,481 at risk EG003
Cervical cord compression	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cervical myelopathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Dizziness	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Facial nerve disorder	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Headache	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hemianopia	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Intensive care unit acquired weakness	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Lumbosacral radiculopathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Migraine	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Monoplegia	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Multiple sclerosis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Myelopathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Nerve root compression	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Neuritis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pachymeningitis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Post herpetic neuralgia	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Presyncope	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Quadriparesis	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Radicular syndrome	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Sciatica	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0019 affected3,358 at risk EG00210 affected4,481 at risk EG003
Seizure	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Sensory loss	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Serotonin syndrome	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Small fibre neuropathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Spinal claudication	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Spinal subdural haematoma	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Spondylitic myelopathy	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Syncope	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0015 affected3,358 at risk EG0026 affected4,481 at risk EG003
Tension headache	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG00111 affected3,358 at risk EG00213 affected4,481 at risk EG003
Vasculitis cerebral	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Foetal death	Pregnancy, puerperium and perinatal conditions	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Unintended pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Device dislocation	Product Issues	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Device electrical impedance issue	Product Issues	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Device loosening	Product Issues	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Affective disorder	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Anxiety disorder	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Confusional state	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Depression	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Drug abuse	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Post-traumatic stress disorder	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Psychotic disorder due to a general medical condition	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Restlessness	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Stress	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0006 affected1,123 at risk EG0016 affected3,358 at risk EG00212 affected4,481 at risk EG003
Anuria	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Mixed incontinence	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0015 affected3,358 at risk EG0027 affected4,481 at risk EG003
Obstructive uropathy	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pyelocaliectasis	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0011 affected3,358 at risk EG0024 affected4,481 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ureteral necrosis	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Urethral meatus stenosis	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Adenomyosis	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0014 affected3,358 at risk EG0024 affected4,481 at risk EG003
Breast enlargement	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Breast hyperplasia	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Endometrial dysplasia	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Fallopian tube cyst	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Menometrorrhagia	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0018 affected3,358 at risk EG0029 affected4,481 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0012 affected3,358 at risk EG0023 affected4,481 at risk EG003
Prostatomegaly	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0011 affected3,358 at risk EG0024 affected4,481 at risk EG003
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Vaginal prolapse	Reproductive system and breast disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0012 affected3,358 at risk EG0024 affected4,481 at risk EG003
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0005 affected1,123 at risk EG0016 affected3,358 at risk EG00211 affected4,481 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0014 affected3,358 at risk EG0026 affected4,481 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0013 affected3,358 at risk EG0024 affected4,481 at risk EG003
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lower respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0013 affected3,358 at risk EG0023 affected4,481 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG00116 affected3,358 at risk EG00219 affected4,481 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0005 affected1,123 at risk EG0013 affected3,358 at risk EG0028 affected4,481 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Scar pain	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Activities of daily living impaired	Social circumstances	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Physical abuse	Social circumstances	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Arthrodesis	Surgical and medical procedures	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Knee arthroplasty	Surgical and medical procedures	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Accelerated hypertension	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0013 affected3,358 at risk EG0025 affected4,481 at risk EG003
Aortic dissection	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0006 affected1,123 at risk EG0019 affected3,358 at risk EG00215 affected4,481 at risk EG003
Extremity necrosis	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0011 affected3,358 at risk EG0022 affected4,481 at risk EG003
Haematoma	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Hypertension	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0017 affected3,358 at risk EG00210 affected4,481 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0003 affected1,123 at risk EG0018 affected3,358 at risk EG00211 affected4,481 at risk EG003
Hypotension	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Peripheral venous disease	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0012 affected3,358 at risk EG0022 affected4,481 at risk EG003
Shock	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Thromboangiitis obliterans	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0011 affected3,358 at risk EG0021 affected4,481 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0002 affected1,123 at risk EG0011 affected3,358 at risk EG0023 affected4,481 at risk EG003
Varicose vein	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0015 affected3,358 at risk EG0025 affected4,481 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG0001 affected1,123 at risk EG0010 affected3,358 at risk EG0021 affected4,481 at risk EG003
Herpes zoster 1	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0010 affected3,358 at risk EG0020 affected4,481 at risk EG003
Pneumonia 1	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0010 affected3,358 at risk EG0020 affected4,481 at risk EG003
Humerus fracture 1	Injury, poisoning and procedural complications	MedDRA v20.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0010 affected3,358 at risk EG0020 affected4,481 at risk EG003
Basal cell carcinoma 1	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v20.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0010 affected3,358 at risk EG0020 affected4,481 at risk EG003
Depression 1	Psychiatric disorders	MedDRA v20.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0010 affected3,358 at risk EG0020 affected4,481 at risk EG003

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.
BG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)	Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID.	25	1,123	346	1,123	807	1,123
EG001	Initial Period: Tofacitinib 10 mg BID	Participants with average total daily dose across study >=15 were assigned to 10 mg BID.	30	3,358	997	3,358	2,422	3,358
EG002	Initial Period: All Tofacitinib	All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	55	4,481	1,343	4,481	3,229	4,481
EG003	Extension Period: Tofacitinib 5 mg	Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.	0	48	5	48	3	48

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA v19.1	Non-systematic Assessment	EG00064 affected1,123 at risk EG001176 affected3,358 at risk EG002240 affected4,481 at risk EG0030 affected48 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG00072 affected1,123 at risk EG001213 affected3,358 at risk EG002285 affected4,481 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v19.1	Non-systematic Assessment	EG00056 affected1,123 at risk EG001175 affected3,358 at risk EG002231 affected4,481 at risk EG003
Bronchitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG000141 affected1,123 at risk EG001430 affected3,358 at risk EG002571 affected4,481 at risk EG003
Herpes zoster	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG000117 affected1,123 at risk EG001373 affected3,358 at risk EG002490 affected4,481 at risk EG003
Influenza	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG00078 affected1,123 at risk EG001199 affected3,358 at risk EG002277 affected4,481 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG000138 affected1,123 at risk EG001517 affected3,358 at risk EG002655 affected4,481 at risk EG003
Pharyngitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG00058 affected1,123 at risk EG001148 affected3,358 at risk EG002206 affected4,481 at risk EG003
Sinusitis	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG00070 affected1,123 at risk EG001239 affected3,358 at risk EG002309 affected4,481 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG000228 affected1,123 at risk EG001613 affected3,358 at risk EG002841 affected4,481 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v19.1	Non-systematic Assessment	EG000161 affected1,123 at risk EG001447 affected3,358 at risk EG002608 affected4,481 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v19.1	Non-systematic Assessment	EG00064 affected1,123 at risk EG001209 affected3,358 at risk EG002273 affected4,481 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG00063 affected1,123 at risk EG001122 affected3,358 at risk EG002185 affected4,481 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG00091 affected1,123 at risk EG001247 affected3,358 at risk EG002338 affected4,481 at risk EG003
Blood creatinine increased	Investigations	MedDRA v19.1	Non-systematic Assessment	EG00060 affected1,123 at risk EG001116 affected3,358 at risk EG002176 affected4,481 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v19.1	Non-systematic Assessment	EG00062 affected1,123 at risk EG001153 affected3,358 at risk EG002215 affected4,481 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG00087 affected1,123 at risk EG001265 affected3,358 at risk EG002352 affected4,481 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG000106 affected1,123 at risk EG001291 affected3,358 at risk EG002397 affected4,481 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA v19.1	Non-systematic Assessment	EG000103 affected1,123 at risk EG001293 affected3,358 at risk EG002396 affected4,481 at risk EG003
Headache	Nervous system disorders	MedDRA v19.1	Non-systematic Assessment	EG00067 affected1,123 at risk EG001201 affected3,358 at risk EG002268 affected4,481 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v19.1	Non-systematic Assessment	EG00065 affected1,123 at risk EG001202 affected3,358 at risk EG002267 affected4,481 at risk EG003
Hypertension	Vascular disorders	MedDRA v19.1	Non-systematic Assessment	EG000139 affected1,123 at risk EG001311 affected3,358 at risk EG002450 affected4,481 at risk EG003
Bronchitis 1	Infections and infestations	MedDRA v20.1	Non-systematic Assessment	EG0000 affected1,123 at risk EG0010 affected3,358 at risk EG0020 affected4,481 at risk EG003