Injectable Cabotegravir Compared to TDF/FTC For PrEP in H... | NCT02720094

ID	Type	Description	Link
20725	Registry Identifier	DAIDS ES

Name	Class
ViiV Healthcare	INDUSTRY
Gilead Sciences	INDUSTRY

Label	Type	Description	Intervention Names
Arm A	Experimental	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.	Drug: Cabotegravir Oral Tablet Drug: TDF/FTC tablets Drug: Placebo for TDF/FTC tablets Drug: CAB LA
Arm B	Experimental	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.	Drug: TDF/FTC tablets Drug: Placebo for cabotegravir oral tablet Drug: Placebo for CAB LA

Name	Type	Description	Arm Group Labels	Other Names
Cabotegravir Oral Tablet	Drug	30 mg tablet	Arm A	Oral cabotegravir

Measure	Description	Time Frame
Number of Participants With Documented Incident HIV Infections During Steps 1 and 2	All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).	HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.
Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events	The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2.	Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).

Measure	Description	Time Frame
Number of Participants With Documented Incident HIV Infections in Step 2	Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population	HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.

Name	Affiliation	Role
Raphael J. Landovitz, MD, MSc	University of California, Los Angeles	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Alabama CRS		Birmingham	Alabama	35294	United States
UCLA Vine Street Clinic CRS

PubMed Identifier	Type	Citation	Retractions
40590452	Derived	Brown TT, Arao RF, Warsi M, Phanuphak N, Vasconcelos R, Oyedele T, Sullivan PA, Hanscom B, Rooney JF, Rinehart AR, McCauley M, Grinsztejn B, Landovitz RJ. Bone Changes With Long-Acting Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention in Cisgender Men and Transgender Women: HPTN 083. Clin Infect Dis. 2025 Dec 24;81(5):983-986. doi: 10.1093/cid/ciaf221.
38783534

ID	Title	Description
FG000	Cabotegravir	In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 31, 2019	Feb 2, 2022

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

Number of Participants With Documented Incident HIV Infections During Steps 1 and 2

All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).

mITT Population (Steps 1 and 2): Participants who were inappropriately enrolled are excluded. Participants who were found by the EAC to be HIV infected at enrollment are excluded.

Posted

Count of Participants

Participants

HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Units	Counts
Participants	OG0002280 OG0012281

Title

Denominators

Categories

Title	Measurements
	OG00013 OG00139

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		0.0005		A bias-adjusted hazard ratio	0.340			2-Sided	95	0.18	0.62			The bias-adjusted hazard ratio, CI, and p-value account for the group-sequential trial design and the early stopping time.		Superiority
OG000 OG001		Regression, Cox

Primary

Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events

The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2.

Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.

Posted

Count of Participants

Participants

Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Number of Participants With Documented Incident HIV Infections in Step 2

Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population

Injection step 2 efficacy: The subgroup of the mITT population who received at least one injection and had at least one HIV result assessed after the first injection visit.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Changes From Baseline in Creatinine and Creatinine Clearance Levels

Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit.

All subjects who received at least one dose of study product, and for whom have results for creatine and creatinine clearance at enrollment AND for at least one of the following two time points: Week 57 and Week 105.

Posted

Median

Inter-Quartile Range

umol/L

Reported week 57 (injection visit #8) and week 105 (injection visit #14)

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs)

Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus.

Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.

Posted

Count of Participants

Participants

Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks)

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters

Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection.

All participants in the mITT population who acquired HIV, including those who were found to have acquired HIV prior to randomization.

Posted

Count of Participants

Participants

Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Changes in Weight From Baseline

Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit.

Enrolled participants with available data at each visit

Posted

Median

Inter-Quartile Range

Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks).

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Changes in Systolic Blood Pressure From Baseline

Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.

Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.

Posted

Median

Inter-Quartile Range

mmHg

Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Changes in Diastolic Blood Pressure From Baseline

Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.

Posted

Median

Inter-Quartile Range

mmHg

Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Changes in Pulse Rate From Baseline

Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit.

Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.

Posted

Median

Inter-Quartile Range

beats/min

Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Changes in Fasting Glucose Levels From Baseline

Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations.

Participants who were inappropriately enrolled are excluded. Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.

Posted

Median

Inter-Quartile Range

mg/dL

Assessed at weeks 57 and 105.

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Changes in Fasting Lipid Profile From Baseline

Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations.

Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.

Posted

Median

Inter-Quartile Range

mg/dL

Assessed at weeks 57 and 105.

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Summary of Overall Satisfaction With Study Product

Summary of overall satisfaction with study product at Week 17 and Week 41. 0 represents None of the time and 6 represents All of the times for the questions 'How often is it inconvenient or difficult to receive oral study medication as recommended?' and 'How often do you find it inconvenient or difficult to receive your injection as recommended?', 0 represents None at all and 6 represent A very great deal for the questions 'How much pain or discomfort have you experienced with your oral study medication (tablets)?' and 'How much pain or discomfort have you experienced with your injection?'.

All subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled, and for whom have results for satisfaction with study product at a given visit.

Posted

Count of Participants

Participants

Assessed at Week 17, 41

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC

Secondary

Summary of Preference Based on Satisfaction With Study Product

Summary of preference based on satisfaction with study product at Week 17 and Week 41

All subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled, and for whom have results for preference based on satisfaction with study product at a given visit.

Posted

Count of Participants

Participants

Assessed at week 17, 41

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Secondary

Change From Baseline of Mean Z-scores of Bone Mineral Density

Change from baseline of mean standard scores (Z-scores) to week 57 and week 105 in the bone mineral density (BMD) at femoral neck, lumbar spine, and total hip region were summarized using DEXA subset. BMD z-scores from Hologic instrument scans were standardized by race, age, and gender using the Hologic DXA Reference Data. Male reference values were used for men who have sex with men and female reference values for transgender women. A z-score of 0 represents the mean of the analysis population standardized by race, age, and gender. Higher z-scores in BMD indicate a better outcomes. A z-score of -2.0 or lower is generally considered below the expected range, potentially indicating secondary osteoporosis requiring further medical evaluation.

DEXA-substudy participants who received at least 10 injections (active CAB or placebo) within 18 months of enrollment

Posted

Mean

Standard Deviation

Z-score

Measured at enrollment, week 57 and week 105

ID	Title	Description
OG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Any Event in SOC	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0017 events6 affected2,285 at risk
Arrhythmia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Atrial flutter	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Cardiac disorder	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events1 affected2,285 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Congenital, familial and genetic disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Thyroglossal cyst	Congenital, familial and genetic disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Ulcerative keratitis	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG00110 events7 affected2,285 at risk
Cannabinoid hyperemesis syndrome	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Intussusception	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pyrexia	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Abdominal abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Abscess limb	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Acute hepatitis B	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Acute hepatitis C	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anal abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00050 events48 affected2,281 at risk EG00140 events38 affected2,285 at risk
Appendicitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0019 events9 affected2,285 at risk
Arthritis gonococcal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Dengue fever	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0013 events3 affected2,285 at risk
Dengue haemorrhagic fever	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Febrile infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0015 events5 affected2,285 at risk
Hepatitis A	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Influenza	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0012 events2 affected2,285 at risk
Kidney infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lymphogranuloma venereum	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Osteomyelitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Otitis media	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Parotitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Secondary syphilis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Shigella infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Tonsillitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Tooth abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Viral pericarditis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00013 events13 affected2,281 at risk EG00126 events26 affected2,285 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lipase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Platelet count decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0010 events0 affected2,285 at risk
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0015 events4 affected2,285 at risk
Brain stem infarction	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events1 affected2,285 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Sciatica	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Seizure	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Status epilepticus	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Acute stress disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Affective disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Aggression	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Alcoholism	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG00026 events23 affected2,281 at risk EG00132 events28 affected2,285 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Borderline personality disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Depression	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0016 events6 affected2,285 at risk
Depression suicidal	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Impulse-control disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Major depression	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Mental status changes	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Substance abuse	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0016 events6 affected2,285 at risk
Suicide attempt	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG00111 events10 affected2,285 at risk
Any Event in SOC	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0014 events2 affected2,285 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events1 affected2,285 at risk
Renal colic	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0010 events0 affected2,285 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0014 events3 affected2,285 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events2 affected2,285 at risk
Vascular occlusion	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Antiphospholipid syndrome	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG00036 events33 affected2,281 at risk EG00140 events35 affected2,285 at risk
Cyclic neutropenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0017 events7 affected2,285 at risk
Lymphocytic infiltration	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0018 events8 affected2,285 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG00018 events15 affected2,281 at risk EG00121 events16 affected2,285 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Angina pectoris	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0017 events7 affected2,285 at risk
Arrhythmia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Bradycardia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Coronary artery disease	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Extrasystoles	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Palpitations	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pericarditis	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tachycardia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Congenital, familial and genetic disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Gilbert's syndrome	Congenital, familial and genetic disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Steatocystoma multiplex	Congenital, familial and genetic disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Thalassaemia	Congenital, familial and genetic disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG00024 events22 affected2,281 at risk EG00124 events24 affected2,285 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0015 events5 affected2,285 at risk
Ear pruritus	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ear swelling	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Tympanic membrane disorder	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events7 affected2,281 at risk EG0016 events6 affected2,285 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hyperprolactinaemia	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG00030 events22 affected2,281 at risk EG00122 events20 affected2,285 at risk
Blepharitis	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Chalazion	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Chorioretinopathy	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0011 events1 affected2,285 at risk
Dry eye	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Eye allergy	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Eye discharge	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Eye inflammation	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Eye irritation	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Eye pain	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Eye pruritus	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Eyelid oedema	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Giant papillary conjunctivitis	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Glaucoma	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Hypermetropia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Iritis	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Keratitis	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lacrimation increased	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Myopia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ocular hyperaemia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events4 affected2,281 at risk EG0012 events2 affected2,285 at risk
Retinal detachment	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Strabismus	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Swelling of eyelid	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ulcerative keratitis	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Vision blurred	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Visual acuity reduced	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Visual impairment	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0014 events4 affected2,285 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0016 events6 affected2,285 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00026 events26 affected2,281 at risk EG00124 events23 affected2,285 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00026 events24 affected2,281 at risk EG00117 events16 affected2,285 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00020 events20 affected2,281 at risk EG00131 events28 affected2,285 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anal polyp	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Anal pruritus	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0016 events5 affected2,285 at risk
Anal skin tags	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Angular cheilitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0015 events4 affected2,285 at risk
Any Event in SOC	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG000638 events450 affected2,281 at risk EG001706 events481 affected2,285 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG00111 events10 affected2,285 at risk
Change of bowel habit	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0013 events3 affected2,285 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00014 events14 affected2,281 at risk EG00116 events16 affected2,285 at risk
Cyclic vomiting syndrome	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Dental caries	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00014 events14 affected2,281 at risk EG00113 events11 affected2,285 at risk
Dental necrosis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG000129 events111 affected2,281 at risk EG001152 events119 affected2,285 at risk
Dysbiosis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00038 events32 affected2,281 at risk EG00133 events31 affected2,285 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Eructation	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00012 events12 affected2,281 at risk EG00113 events12 affected2,285 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00038 events37 affected2,281 at risk EG00141 events41 affected2,285 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00040 events29 affected2,281 at risk EG00127 events24 affected2,285 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00026 events23 affected2,281 at risk EG00115 events15 affected2,285 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gingival recession	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Gingival ulceration	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Glossitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0018 events7 affected2,285 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00045 events42 affected2,281 at risk EG00146 events44 affected2,285 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0015 events4 affected2,285 at risk
Lip exfoliation	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Loose tooth	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Mouth cyst	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Mucous stools	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00022 events22 affected2,281 at risk EG00148 events39 affected2,285 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00016 events15 affected2,281 at risk EG00114 events14 affected2,285 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Oral pain	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Oral pruritus	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Parotid duct obstruction	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events2 affected2,285 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG00116 events15 affected2,285 at risk
Proctitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00015 events14 affected2,281 at risk EG00117 events16 affected2,285 at risk
Rectal discharge	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Rectal fissure	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0016 events5 affected2,285 at risk
Rectal spasm	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Salivary gland enlargement	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Sialocele	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events1 affected2,285 at risk
Steatorrhoea	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Tooth deposit	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00012 events11 affected2,281 at risk EG0017 events7 affected2,285 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00033 events28 affected2,281 at risk EG00148 events44 affected2,285 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Uvulitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00011 events11 affected2,281 at risk EG00122 events22 affected2,285 at risk
Adverse drug reaction	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Adverse food reaction	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	General disorders	MedDRA 23.1	Non-systematic Assessment	EG000359 events229 affected2,281 at risk EG001174 events149 affected2,285 at risk
Application site pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Asthenia	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0014 events4 affected2,285 at risk
Chest discomfort	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Chest pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Chills	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events4 affected2,281 at risk EG0012 events2 affected2,285 at risk
Cyst	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Discomfort	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Drug withdrawal syndrome	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Face oedema	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Facial pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0012 events2 affected2,285 at risk
Fatigue	General disorders	MedDRA 23.1	Non-systematic Assessment	EG00037 events31 affected2,281 at risk EG00114 events14 affected2,285 at risk
Feeling abnormal	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Fibrosis	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gait disturbance	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hangover	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Hernia	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Induration	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Influenza like illness	General disorders	MedDRA 23.1	Non-systematic Assessment	EG00038 events28 affected2,281 at risk EG00123 events20 affected2,285 at risk
Injury associated with device	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Lithiasis	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Malaise	General disorders	MedDRA 23.1	Non-systematic Assessment	EG00044 events30 affected2,281 at risk EG00118 events16 affected2,285 at risk
Medical device site ulcer	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Mucosal disorder	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nodule	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0011 events1 affected2,285 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG00013 events12 affected2,281 at risk EG0017 events7 affected2,285 at risk
Peripheral swelling	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Polyp	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Puncture site pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Puncture site swelling	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pyrexia	General disorders	MedDRA 23.1	Non-systematic Assessment	EG000186 events121 affected2,281 at risk EG00169 events62 affected2,285 at risk
Swelling face	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Vaccination site pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Xerosis	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG00019 events16 affected2,281 at risk EG00124 events14 affected2,285 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Deficiency of bile secretion	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hepatic fibrosis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events5 affected2,281 at risk EG00112 events5 affected2,285 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Jaundice	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Nonalcoholic fatty liver disease	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Allergy to animal	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Allergy to chemicals	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG00064 events59 affected2,281 at risk EG00154 events53 affected2,285 at risk
Autoimmune disorder	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0013 events3 affected2,285 at risk
Food allergy	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG00016 events14 affected2,281 at risk EG0017 events7 affected2,285 at risk
Hypersensitivity	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG00015 events13 affected2,281 at risk EG00112 events11 affected2,285 at risk
Jarisch-Herxheimer reaction	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Mite allergy	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Multiple allergies	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0013 events3 affected2,285 at risk
Mycotic allergy	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Perfume sensitivity	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Seasonal allergy	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG00018 events18 affected2,281 at risk EG00119 events19 affected2,285 at risk
Serum sickness	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Abdominal abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Abscess jaw	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Abscess limb	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG00112 events12 affected2,285 at risk
Abscess neck	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Abscess of eyelid	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Abscess rupture	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Acanthamoeba keratitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Acarodermatitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00027 events26 affected2,281 at risk EG00148 events43 affected2,285 at risk
Acute hepatitis B	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Acute hepatitis C	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG0016 events6 affected2,285 at risk
Acute sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0019 events9 affected2,285 at risk
Amoebic dysentery	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anal abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events5 affected2,281 at risk EG00110 events9 affected2,285 at risk
Anal candidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anal chlamydia infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG000297 events248 affected2,281 at risk EG001326 events267 affected2,285 at risk
Anal fistula infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anal fungal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anorectal human papilloma virus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0009 events9 affected2,281 at risk EG00112 events12 affected2,285 at risk
Any Event in SOC	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003,515 events1,360 affected2,281 at risk EG0013,456 events1,344 affected2,285 at risk
Appendicitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Arboviral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Atypical pneumonia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Bacteraemia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events5 affected2,281 at risk EG0012 events2 affected2,285 at risk
Bacterial infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Bacterial prostatitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events1 affected2,285 at risk
Bacterial urethritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00010 events9 affected2,281 at risk EG0019 events9 affected2,285 at risk
Bacteriuria	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Balanitis candida	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0013 events3 affected2,285 at risk
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Blastocystis infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Body tinea	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0008 events7 affected2,281 at risk EG0016 events6 affected2,285 at risk
Bone abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Breast abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00030 events28 affected2,281 at risk EG00132 events31 affected2,285 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Bronchitis viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0014 events3 affected2,285 at risk
Bullous impetigo	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
COVID-19	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00014 events14 affected2,281 at risk EG00111 events11 affected2,285 at risk
Campylobacter infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events1 affected2,285 at risk
Candida infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Candida urethritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Carbuncle	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00024 events22 affected2,281 at risk EG00111 events11 affected2,285 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Chancroid	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Chest wall abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Chikungunya virus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Chlamydial infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00077 events66 affected2,281 at risk EG00174 events66 affected2,285 at risk
Chronic hepatitis C	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Chronic sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00019 events19 affected2,281 at risk EG00127 events24 affected2,285 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Conjunctivitis viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0013 events3 affected2,285 at risk
Cryptosporidiosis infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Cystitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Cystitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Dengue fever	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0017 events6 affected2,285 at risk
Dengue haemorrhagic fever	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Dermatophytosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0015 events5 affected2,285 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00012 events12 affected2,281 at risk EG0018 events8 affected2,285 at risk
Diverticulitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Dysentery	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ear infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00013 events13 affected2,281 at risk EG00119 events15 affected2,285 at risk
Ear infection bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ear lobe infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Enterobiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Enterovirus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0010 events0 affected2,285 at risk
Epididymitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0017 events7 affected2,285 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Erysipelas	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
External ear cellulitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Eye infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Eye infection bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Eye infection gonococcal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Eye infection staphylococcal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Febrile infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0009 events9 affected2,281 at risk EG0015 events5 affected2,285 at risk
Folliculitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00017 events16 affected2,281 at risk EG00116 events14 affected2,285 at risk
Fungal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Fungal skin infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0017 events7 affected2,285 at risk
Furuncle	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00016 events15 affected2,281 at risk EG00116 events15 affected2,285 at risk
Gastric infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00088 events83 affected2,281 at risk EG00194 events87 affected2,285 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Gastroenteritis cryptosporidial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gastroenteritis shigella	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00022 events22 affected2,281 at risk EG00114 events14 affected2,285 at risk
Gastrointestinal bacterial infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00011 events11 affected2,281 at risk EG0014 events4 affected2,285 at risk
Gastrointestinal protozoal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Genital candidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0008 events6 affected2,281 at risk EG0015 events5 affected2,285 at risk
Genital herpes	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00033 events23 affected2,281 at risk EG00136 events22 affected2,285 at risk
Genital herpes simplex	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00012 events11 affected2,281 at risk EG00114 events10 affected2,285 at risk
Genital herpes zoster	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Genital infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Genital infection bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Genital infection fungal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Genitourinary chlamydia infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00037 events34 affected2,281 at risk EG00127 events23 affected2,285 at risk
Genitourinary tract gonococcal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00021 events21 affected2,281 at risk EG00117 events16 affected2,285 at risk
Giardiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0013 events3 affected2,285 at risk
Gingival abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gingivitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG0019 events9 affected2,285 at risk
Gonococcal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0012 events2 affected2,285 at risk
Gonorrhoea	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00060 events51 affected2,281 at risk EG00157 events49 affected2,285 at risk
Groin infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Helicobacter infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Helminthic infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hepatitis A	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hepatitis E	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hepatitis syphilitic	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Herpes dermatitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Herpes simplex	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00019 events14 affected2,281 at risk EG00113 events10 affected2,285 at risk
Herpes virus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Herpes zoster	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG00112 events12 affected2,285 at risk
Hordeolum	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00017 events17 affected2,281 at risk EG00119 events19 affected2,285 at risk
Impetigo	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Infected bite	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Infected dermal cyst	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Infection parasitic	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0015 events5 affected2,285 at risk
Infectious thyroiditis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Influenza	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00064 events62 affected2,281 at risk EG00165 events63 affected2,285 at risk
Labyrinthitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Large intestine infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Laryngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Laryngitis viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Latent syphilis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00058 events56 affected2,281 at risk EG00154 events50 affected2,285 at risk
Latent tuberculosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lice infestation	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0016 events6 affected2,285 at risk
Localised infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0014 events4 affected2,285 at risk
Lyme disease	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lymph node tuberculosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lymphadenitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lymphangitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lymphogranuloma venereum	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0016 events6 affected2,285 at risk
Malassezia infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Mastitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Measles	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Molluscum contagiosum	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Mononucleosis syndrome	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Mumps	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0012 events2 affected2,285 at risk
Mycoplasma genitalium infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Myringitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nasal herpes	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG000421 events295 affected2,281 at risk EG001380 events273 affected2,285 at risk
Onychomycosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00014 events13 affected2,281 at risk EG00111 events11 affected2,285 at risk
Oral candidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Oral fungal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Oral herpes	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00029 events26 affected2,281 at risk EG00127 events24 affected2,285 at risk
Oral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Oral pustule	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Oral viral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Orchitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Oropharyngeal gonococcal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00035 events33 affected2,281 at risk EG00129 events27 affected2,285 at risk
Osteomyelitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Otitis externa	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG0018 events6 affected2,285 at risk
Otitis externa bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Otitis externa fungal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Otitis media	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0008 events7 affected2,281 at risk EG0013 events3 affected2,285 at risk
Otitis media acute	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0009 events7 affected2,281 at risk EG0012 events2 affected2,285 at risk
Otitis media bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0010 events0 affected2,285 at risk
Otitis media viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Papilloma viral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG0014 events4 affected2,285 at risk
Parasitic gastroenteritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG00110 events9 affected2,285 at risk
Paronychia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0009 events9 affected2,281 at risk EG0018 events8 affected2,285 at risk
Parotitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Pelvic abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Penile infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Pericoronitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Periodontitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Perirectal abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Pharyngeal chlamydia infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00011 events11 affected2,281 at risk EG0015 events5 affected2,285 at risk
Pharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG000124 events104 affected2,281 at risk EG001101 events89 affected2,285 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0009 events9 affected2,281 at risk EG0018 events8 affected2,285 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00052 events46 affected2,281 at risk EG00134 events29 affected2,285 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0019 events8 affected2,285 at risk
Pilonidal cyst	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00012 events12 affected2,281 at risk EG00111 events11 affected2,285 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Post procedural infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Postoperative wound infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Primary syphilis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00025 events23 affected2,281 at risk EG00125 events23 affected2,285 at risk
Proctitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events1 affected2,281 at risk EG0014 events4 affected2,285 at risk
Proctitis chlamydial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00039 events34 affected2,281 at risk EG00147 events41 affected2,285 at risk
Proctitis gonococcal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG000235 events200 affected2,281 at risk EG001256 events225 affected2,285 at risk
Proctitis herpes	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pseudomonas infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pulpitis dental	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Puncture site infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Purulent discharge	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Pyelonephritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Rectal abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0012 events2 affected2,285 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Rhinitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00035 events26 affected2,281 at risk EG00122 events18 affected2,285 at risk
Rocky mountain spotted fever	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Root canal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Scrotal abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Secondary syphilis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00026 events26 affected2,281 at risk EG00131 events31 affected2,285 at risk
Severe acute respiratory syndrome	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Sexually transmitted disease	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0015 events5 affected2,285 at risk
Shigella infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events1 affected2,285 at risk
Sialoadenitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00050 events44 affected2,281 at risk EG00152 events47 affected2,285 at risk
Sinusitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events4 affected2,281 at risk EG00115 events15 affected2,285 at risk
Skin bacterial infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Skin infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Staphylococcal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Streptococcal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Strongyloidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00013 events12 affected2,281 at risk EG0019 events7 affected2,285 at risk
Suspected COVID-19	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Syphilis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG000203 events187 affected2,281 at risk EG001219 events198 affected2,285 at risk
Syphilis anal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Syphilis genital	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tinea cruris	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00016 events12 affected2,281 at risk EG00111 events11 affected2,285 at risk
Tinea infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Tinea pedis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0018 events8 affected2,285 at risk
Tinea versicolour	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG00110 events10 affected2,285 at risk
Tonsillitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00063 events56 affected2,281 at risk EG00167 events59 affected2,285 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00028 events23 affected2,281 at risk EG00116 events15 affected2,285 at risk
Tonsillitis streptococcal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tooth abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00016 events15 affected2,281 at risk EG00118 events14 affected2,285 at risk
Tooth infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00015 events15 affected2,281 at risk EG00115 events15 affected2,285 at risk
Tracheitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tracheobronchitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Trichomoniasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Typhoid fever	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG000245 events176 affected2,281 at risk EG001223 events170 affected2,285 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Urethritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00060 events51 affected2,281 at risk EG00163 events58 affected2,285 at risk
Urethritis chlamydial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00062 events56 affected2,281 at risk EG00166 events60 affected2,285 at risk
Urethritis gonococcal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00070 events64 affected2,281 at risk EG00161 events51 affected2,285 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00027 events25 affected2,281 at risk EG00124 events23 affected2,285 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Varicella	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Viral diarrhoea	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0013 events3 affected2,285 at risk
Viral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00062 events58 affected2,281 at risk EG00165 events48 affected2,285 at risk
Viral pharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00014 events14 affected2,281 at risk EG0016 events6 affected2,285 at risk
Viral rash	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Viral rhinitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Viral sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG00111 events9 affected2,285 at risk
Viral tonsillitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0017 events7 affected2,285 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00077 events59 affected2,281 at risk EG00177 events66 affected2,285 at risk
Vulvitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Wound infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0009 events9 affected2,281 at risk EG0014 events4 affected2,285 at risk
Wound infection bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0017 events5 affected2,285 at risk
Anal injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG0016 events6 affected2,285 at risk
Animal scratch	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0014 events4 affected2,285 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0014 events4 affected2,285 at risk
Any Event in SOC	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG000420 events286 affected2,281 at risk EG001437 events317 affected2,285 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG00120 events18 affected2,285 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Bite	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0010 events0 affected2,285 at risk
Burn oesophageal	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Burns first degree	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0012 events2 affected2,285 at risk
Buttock injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0006 events4 affected2,281 at risk EG0014 events4 affected2,285 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00016 events16 affected2,281 at risk EG00120 events18 affected2,285 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0014 events4 affected2,285 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Ear injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Exposure to communicable disease	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00021 events17 affected2,281 at risk EG00116 events14 affected2,285 at risk
Exposure to contaminated air	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Exposure to toxic agent	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Eyelid injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0014 events4 affected2,285 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Foreign body in eye	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0012 events2 affected2,285 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0015 events5 affected2,285 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00014 events12 affected2,281 at risk EG0019 events8 affected2,285 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00039 events34 affected2,281 at risk EG00138 events36 affected2,285 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00015 events14 affected2,281 at risk EG00121 events20 affected2,285 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Mouth injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0015 events5 affected2,285 at risk
Muscle contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00035 events33 affected2,281 at risk EG00136 events31 affected2,285 at risk
Nail avulsion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nail injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Penis injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Perineal injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Periorbital haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Post procedural constipation	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Post procedural contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Post procedural discomfort	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Post procedural inflammation	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0017 events5 affected2,285 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00010 events9 affected2,281 at risk EG0018 events7 affected2,285 at risk
Post vaccination syndrome	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Prescribed overdose	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00073 events66 affected2,281 at risk EG00182 events71 affected2,285 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Retinal injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00022 events20 affected2,281 at risk EG00110 events10 affected2,285 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00028 events25 affected2,281 at risk EG00125 events24 affected2,285 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0015 events5 affected2,285 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG00011 events10 affected2,281 at risk EG0018 events8 affected2,285 at risk
Tooth injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0015 events5 affected2,285 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000189 events159 affected2,281 at risk EG001238 events192 affected2,285 at risk
Amylase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000282 events148 affected2,281 at risk EG001292 events169 affected2,285 at risk
Any Event in SOC	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0008,346 events1,892 affected2,281 at risk EG0019,028 events1,914 affected2,285 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000216 events188 affected2,281 at risk EG001228 events197 affected2,285 at risk
Bilirubin conjugated increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events1 affected2,285 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0018 events7 affected2,285 at risk
Blood bicarbonate decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Blood bilirubin increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000150 events89 affected2,281 at risk EG001169 events108 affected2,285 at risk
Blood calcium decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0016 events6 affected2,285 at risk
Blood calcium increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Blood cholesterol increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00042 events41 affected2,281 at risk EG00124 events24 affected2,285 at risk
Blood creatine decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Blood creatine increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0011 events1 affected2,285 at risk
Blood creatine phosphokinase decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000678 events484 affected2,281 at risk EG001682 events470 affected2,285 at risk
Blood creatinine decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00017 events16 affected2,281 at risk EG00115 events15 affected2,285 at risk
Blood creatinine increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000711 events382 affected2,281 at risk EG001783 events428 affected2,285 at risk
Blood glucose decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000119 events98 affected2,281 at risk EG001130 events103 affected2,285 at risk
Blood glucose increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000302 events199 affected2,281 at risk EG001190 events123 affected2,285 at risk
Blood phosphorus decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000118 events90 affected2,281 at risk EG001152 events110 affected2,285 at risk
Blood phosphorus increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Blood potassium decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Blood potassium increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0016 events6 affected2,285 at risk
Blood pressure decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Blood pressure diastolic abnormal	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Blood pressure diastolic increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Blood pressure increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00029 events22 affected2,281 at risk EG00127 events19 affected2,285 at risk
Blood pressure systolic increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Blood sodium decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Blood sodium increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Blood testosterone decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Blood triglycerides increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00033 events31 affected2,281 at risk EG00130 events27 affected2,285 at risk
Blood uric acid increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0004,777 events1,589 affected2,281 at risk EG0015,351 events1,671 affected2,285 at risk
Creatinine renal clearance increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0016 events6 affected2,285 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0004 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00016 events12 affected2,281 at risk EG00128 events19 affected2,285 at risk
Glucose urine present	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
HLA-B*27 positive	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Haemoglobin decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Heart rate increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lipase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG000457 events249 affected2,281 at risk EG001468 events260 affected2,285 at risk
Lipids increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Low density lipoprotein increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00061 events60 affected2,281 at risk EG00128 events28 affected2,285 at risk
Lymphocyte count decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00013 events12 affected2,281 at risk EG00113 events12 affected2,285 at risk
Lymphocyte count increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Neutrophil count decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00038 events22 affected2,281 at risk EG00161 events35 affected2,285 at risk
Neutrophil count increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Platelet count decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0008 events6 affected2,281 at risk EG0012 events2 affected2,285 at risk
Protein urine	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Protein urine present	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Red blood cells urine	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Weight decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG00026 events18 affected2,281 at risk EG00157 events41 affected2,285 at risk
White blood cell count decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0009 events2 affected2,281 at risk EG0014 events2 affected2,285 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG00044 events35 affected2,281 at risk EG00194 events63 affected2,285 at risk
Any Event in SOC	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG000169 events128 affected2,281 at risk EG001228 events160 affected2,285 at risk
Dairy intolerance	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG0015 events5 affected2,285 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0015 events5 affected2,285 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Fructose intolerance	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Gout	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0015 events4 affected2,285 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events1 affected2,285 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0014 events4 affected2,285 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG00028 events20 affected2,281 at risk EG00134 events18 affected2,285 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0014 events4 affected2,285 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG00030 events23 affected2,281 at risk EG00128 events24 affected2,285 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG00010 events8 affected2,281 at risk EG00118 events17 affected2,285 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lipid metabolism disorder	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0013 events3 affected2,285 at risk
Overweight	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events1 affected2,285 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0016 events6 affected2,285 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG000319 events247 affected2,281 at risk EG001325 events255 affected2,285 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00044 events42 affected2,281 at risk EG00150 events44 affected2,285 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0011 events1 affected2,285 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00090 events75 affected2,281 at risk EG00193 events88 affected2,285 at risk
Bone cyst	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Chondritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0013 events3 affected2,285 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG0017 events7 affected2,285 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0018 events5 affected2,285 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0014 events4 affected2,285 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0007 events7 affected2,281 at risk EG0011 events1 affected2,285 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0009 events9 affected2,281 at risk EG00111 events11 affected2,285 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0014 events4 affected2,285 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00060 events58 affected2,281 at risk EG00163 events53 affected2,285 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00013 events12 affected2,281 at risk EG00111 events11 affected2,285 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00017 events17 affected2,281 at risk EG00123 events21 affected2,285 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0018 events8 affected2,285 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0018 events7 affected2,285 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Spinal retrolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0013 events3 affected2,285 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG00021 events19 affected2,281 at risk EG00124 events21 affected2,285 at risk
Any Event in SOC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG00038 events32 affected2,281 at risk EG00139 events33 affected2,285 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events1 affected2,285 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Oral papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Penile wart	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0003 events2 affected2,281 at risk EG0015 events5 affected2,285 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Amputation stump pain	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG000388 events273 affected2,281 at risk EG001387 events270 affected2,285 at risk
Balance disorder	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Burning sensation	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Cluster headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Cubital tunnel syndrome	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Disturbance in attention	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG00013 events11 affected2,281 at risk EG00120 events18 affected2,285 at risk
Dizziness postural	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Dystonia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Essential tremor	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Exertional headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Facial paralysis	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG000275 events204 affected2,281 at risk EG001273 events195 affected2,285 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0015 events5 affected2,285 at risk
Lethargy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events1 affected2,285 at risk
Loss of consciousness	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Migraine	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG00027 events18 affected2,281 at risk EG00113 events13 affected2,285 at risk
Migraine with aura	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Nerve compression	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Neuralgia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Presyncope	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0012 events2 affected2,285 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Radiculopathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Sciatica	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0015 events5 affected2,285 at risk
Seizure	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0014 events4 affected2,285 at risk
Seizure like phenomena	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Sinus headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Somnolence	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Syncope	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG00110 events8 affected2,285 at risk
Taste disorder	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Tension headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG00027 events24 affected2,281 at risk EG00119 events17 affected2,285 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Acute stress disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0010 events0 affected2,285 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0012 events2 affected2,285 at risk
Alcoholism	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0010 events0 affected2,285 at risk
Anxiety	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG00062 events57 affected2,281 at risk EG00145 events45 affected2,285 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0013 events3 affected2,285 at risk
Any Event in SOC	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG000285 events220 affected2,281 at risk EG001247 events196 affected2,285 at risk
Attention deficit hyperactivity disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0016 events6 affected2,285 at risk
Bipolar II disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0014 events4 affected2,285 at risk
Borderline personality disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Bulimia nervosa	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Confusional state	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Depressed mood	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0019 events9 affected2,285 at risk
Depression	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG00067 events66 affected2,281 at risk EG00152 events50 affected2,285 at risk
Depressive symptom	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Discouragement	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Drug abuse	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Drug dependence	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Drug use disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Emotional disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Emotional distress	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Flashback	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gambling disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Gender dysphoria	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Generalised anxiety disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Grief reaction	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hallucinations, mixed	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Homicidal ideation	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Initial insomnia	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Insomnia	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG00056 events49 affected2,281 at risk EG00156 events53 affected2,285 at risk
Intentional self-injury	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Irritability	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Libido decreased	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0013 events3 affected2,285 at risk
Major depression	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0014 events4 affected2,285 at risk
Mania	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Mental disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Mental fatigue	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Mixed anxiety and depressive disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Mood swings	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nightmare	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Obsessive-compulsive disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Panic attack	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Panic disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Panic reaction	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Persistent depressive disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0014 events4 affected2,285 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Seasonal affective disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Sleep disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Stress	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Substance abuse	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG00112 events11 affected2,285 at risk
Suicide attempt	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Thinking abnormal	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG00092 events77 affected2,281 at risk EG00185 events78 affected2,285 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Choluria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Chromaturia	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Dysuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG00026 events26 affected2,281 at risk EG00117 events17 affected2,285 at risk
Glycosuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0016 events6 affected2,285 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0009 events9 affected2,281 at risk EG00116 events16 affected2,285 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0009 events7 affected2,281 at risk EG00111 events10 affected2,285 at risk
Nocturia	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Polyuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Proteinuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG00010 events9 affected2,281 at risk EG00111 events11 affected2,285 at risk
Renal colic	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Urethral discharge	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG00027 events23 affected2,281 at risk EG00115 events15 affected2,285 at risk
Urethral syndrome	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Urethritis noninfective	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Urinary retention	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Any Event in SOC	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG00067 events55 affected2,281 at risk EG00160 events54 affected2,285 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events7 affected2,281 at risk EG00110 events9 affected2,285 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Breast enlargement	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0018 events8 affected2,285 at risk
Erection increased	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Galactorrhoea	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Genital burning sensation	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Genital cyst	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Genital discomfort	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Genital paraesthesia	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Genital rash	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Genital ulceration	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0009 events9 affected2,281 at risk EG0018 events8 affected2,285 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Nipple inflammation	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nipple pain	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Penile blister	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Penile burning sensation	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Penile discharge	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0017 events7 affected2,285 at risk
Penile erosion	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Penile oedema	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Penile pain	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Penile rash	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Penile swelling	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0017 events7 affected2,285 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0016 events6 affected2,285 at risk
Scrotal dermatitis	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Scrotal pain	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Scrotal ulcer	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0010 events0 affected2,285 at risk
Testicular cyst	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Testicular oedema	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0010 events0 affected2,285 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Varicocele	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00019 events18 affected2,281 at risk EG00118 events16 affected2,285 at risk
Allergic cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events4 affected2,281 at risk EG0015 events5 affected2,285 at risk
Allergic pharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Allergic respiratory disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Allergic sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 events8 affected2,281 at risk EG0012 events2 affected2,285 at risk
Any Event in SOC	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG000249 events184 affected2,281 at risk EG001265 events194 affected2,285 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG00111 events9 affected2,285 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00046 events42 affected2,281 at risk EG00142 events38 affected2,285 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0014 events4 affected2,285 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0013 events3 affected2,285 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00023 events21 affected2,281 at risk EG00112 events12 affected2,285 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nasal mucosal erosion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Nasal pruritus	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00042 events41 affected2,281 at risk EG00150 events48 affected2,285 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0015 events5 affected2,285 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00033 events32 affected2,281 at risk EG00135 events29 affected2,285 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00017 events16 affected2,281 at risk EG00126 events24 affected2,285 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00013 events13 affected2,281 at risk EG00116 events15 affected2,285 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Small airways disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 events4 affected2,281 at risk EG0013 events3 affected2,285 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Tonsillar inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0011 events1 affected2,285 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00019 events18 affected2,281 at risk EG00127 events25 affected2,285 at risk
Acne cystic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0011 events1 affected2,285 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00010 events10 affected2,281 at risk EG0015 events5 affected2,285 at risk
Any Event in SOC	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG000185 events158 affected2,281 at risk EG001219 events189 affected2,285 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Butterfly rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00010 events10 affected2,281 at risk EG00110 events10 affected2,285 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00011 events10 affected2,281 at risk EG00112 events11 affected2,285 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0014 events4 affected2,285 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00010 events9 affected2,281 at risk EG00112 events12 affected2,285 at risk
Dermatitis papillaris capillitii	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0016 events6 affected2,285 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0015 events5 affected2,285 at risk
Guttate psoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0012 events2 affected2,285 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Lichen nitidus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Lichen sclerosus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0012 events2 affected2,285 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0019 events9 affected2,285 at risk
Penile ulceration	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 events6 affected2,281 at risk EG0017 events7 affected2,285 at risk
Perioral dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0013 events3 affected2,285 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00014 events14 affected2,281 at risk EG00110 events10 affected2,285 at risk
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Pseudofolliculitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 events3 affected2,281 at risk EG0013 events3 affected2,285 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00028 events23 affected2,281 at risk EG00124 events23 affected2,285 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0016 events6 affected2,285 at risk
Rash morbilliform	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0015 events5 affected2,285 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 events5 affected2,281 at risk EG0015 events4 affected2,285 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Sea bather's eruption	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0013 events3 affected2,285 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin striae	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Solar dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events2 affected2,281 at risk EG0010 events0 affected2,285 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00018 events16 affected2,281 at risk EG00125 events19 affected2,285 at risk
Urticaria cholinergic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Urticaria chronic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Xeroderma	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Social circumstances	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0011 events1 affected2,285 at risk
Impaired quality of life	Social circumstances	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Substance use	Social circumstances	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Any Event in SOC	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG00047 events39 affected2,281 at risk EG00137 events31 affected2,285 at risk
Essential hypertension	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Haematoma	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Hot flush	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hyperaemia	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Hypertension	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG00043 events35 affected2,281 at risk EG00129 events24 affected2,285 at risk
Hypertensive crisis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Hypotension	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk
Peripheral venous disease	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
Phlebitis superficial	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0012 events2 affected2,285 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 events1 affected2,281 at risk EG0010 events0 affected2,285 at risk
White coat hypertension	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 events0 affected2,281 at risk EG0011 events1 affected2,285 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D000068698	Tenofovir
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000068679	Emtricitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
BG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
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	Cabotegravir	In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	4	2,281	117	2,281	2,103	2,281
EG001	TDF/FTC	In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	7	2,285	109	2,285	2,114	2,285

ID	Term
C584914	cabotegravir
D000069480	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination