Obstructive Sleep Apnea Master Protocol GPIF: A Study of... | NCT05412004

ID	Type	Description
I8F-MC-GPIF	Other Identifier	Eli Lilly and Company
I8F-MC-GPI1	Other Identifier	Eli Lilly and Company
I8F-MC-GPI2	Other Identifier	Eli Lilly and Company
2021-004552-41	EudraCT Number

Label	Type	Description	Intervention Names
Tirzepatide MTD_GPI1	Experimental	Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks	Drug: Tirzepatide
Placebo_GPI1	Placebo Comparator	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.	Drug: Placebo
Tirzepatide MTD_GPI2	Experimental	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks	Drug: Tirzepatide
Placebo_GPI2	Placebo Comparator	Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tirzepatide	Drug	Administered SC	Tirzepatide MTD_GPI1 Tirzepatide MTD_GPI2

Measure	Description	Time Frame
Change From Baseline in Apnea-Hypopnea Index (AHI)	AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 events/hr = mild; 15-<30 events/hr = moderate; and ≥ 30 events/hr = severe. a significant reduction in values indicates a positive outcome.	Baseline, Week 52

Measure	Description	Time Frame
Percent Change From Baseline in Apnea-Hypopnea Index (AHI)	Percent Change From Baseline in AHI was evaluated.	Baseline, Week 52
Percentage of Participants With ≥50% AHI Reduction From Baseline

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Artemis Institute for Clinical Research		Riverside	California	92503	United States
Teradan Clinical Trials, LLC

PubMed Identifier	Type	Citation	Retractions
41793578	Derived	Shinde S, Kanu C, Varnado OJ, Bednarik J, Dennehy EB, Dias-Barbosa C, Taylor N. Patients' Experiences of Obstructive Sleep Apnea and Tirzepatide Treatment: An Exit Interview Study. Patient. 2026 Jul;19(4):601-614. doi: 10.1007/s40271-026-00808-3. Epub 2026 Mar 7.
41540105	Derived	Malhotra A, Grunstein R, Azarbarzin A, Sands S, Somers VK, Aronne LJ, Jastreboff AM, Lou J, Chakladar S, Dunn JP, Bunck MC, Bednarik J. Tirzepatide on obstructive sleep apnea-related cardiometabolic risk: secondary outcomes of the SURMOUNT-OSA randomized trial. Nat Med. 2026 Feb;32(2):653-659. doi: 10.1038/s41591-025-04071-1. Epub 2026 Jan 15.

Label	URL
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea (SURMOUNT-OSA)	View source

ID	Title	Description
FG000	Tirzepatide MTD_GPI1	Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 2, 2023	Feb 13, 2025

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

Change From Baseline in Apnea-Hypopnea Index (AHI)

AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 events/hr = mild; 15-<30 events/hr = moderate; and ≥ 30 events/hr = severe. a significant reduction in values indicates a positive outcome.

Modified intent-to-treat (mITT) population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

events per hour

Baseline, Week 52

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
OG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG003	Placebo_GPI2	Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.

Units	Counts
Participants	OG000100 OG00186 OG002110 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-25.25± 2.06 OG001-5.25± 2.11 OG002-29.27± 1.99 OG003

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		ANCOVA	ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.	<0.001		LS Mean Change difference	-20.01			2-Sided	95	-25.82	-14.20					Superiority
OG002 OG003		ANCOVA

Secondary

Percent Change From Baseline in Apnea-Hypopnea Index (AHI)

Percent Change From Baseline in AHI was evaluated.

mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 52

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
OG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG003	Placebo_GPI2	Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.

Secondary

Percentage of Participants With ≥50% AHI Reduction From Baseline

Percentage of participants achieving ≥50% AHI reduction from baseline to Week 52 was evaluated.

mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
OG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG003	Placebo_GPI2

Secondary

Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10

The percentage of participants with OSA remission (AHI <5 events per hour of sleep) or with mild OSA without excessive daytime sleepiness (AHI 5-14 events per hour of sleep with ESS ≤10) at Week 52 was evaluated. The ESS is used to assess improvements in excessive daytime sleepiness from baseline to Week 52. The ESS is an 8-item, participant-completed measure that asks the participant to rate, on a scale of 0 (no chance of dozing) to 3 (high chance of dozing), their usual chances of dozing in 8 different daytime situations, with a recall period of "in recent times." The ESS total score is the sum of the 8-item scores and ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.

mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
OG002

Secondary

Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)

SASHB was determined by measuring the respiratory event-associated area under the curve for oxygen desaturation from pre-event baseline and represents the cumulative burden of intermittent hypoxia caused by OSA-related sleep-disordered breathing at sleep.

mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Geometric Least Squares Mean

Standard Error

%.min/hr

Baseline, Week 52

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
OG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.

Secondary

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a (PROMIS SRI) and PROMIS Short Form Sleep Disturbance 8b (PROMIS SD)

PROMIS SRI consists of 8 items that assess self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and perceived functional impairments associated with sleep problems. PROMIS SRI has a recall period of "in the past 7 days" and each item is rated on a 5-point scale from "not at all" to "very much." PROMIS SD consists of 8 items that assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS SD has a recall period of "in the past 7 days" and each item is rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good." For both PROMIS SRI and PROMIS SD, item responses are used to generate T-scores which are standardized scores with a mean of 50 and a standard deviation of 10 (score range cannot be specified for T-scores). Higher T-scores indicate worse outcomes; more sleep-related impairment (PROMIS SRI) or more sleep disturbance (PROMIS SD).

mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

T score

Baseline, Week 52

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.

Secondary

Percent Change From Baseline in Body Weight

Percent Change from Baseline in Body Weight was evaluated.

mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Week 52

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
OG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG003	Placebo_GPI2	Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.

Secondary

Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration

HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.

mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Geometric Least Squares Mean

Standard Error

Milligram per liter (mg/L)

Baseline, Week 52

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
OG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG003

Secondary

Change From Baseline in Systolic Blood Pressure (SBP)

Change in systolic blood pressure from baseline to Week 48 was evaluated.

mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Millimeters of mercury (mm Hg)

Baseline, Week 48

ID	Title	Description
OG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
OG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
OG003	Placebo_GPI2

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG0032 events2 affected114 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Macrocytosis	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Sinus arrhythmia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Autoimmune thyroid disorder	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Goitre	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Hyperparathyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Dry eye	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Photopsia	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Vitreous degeneration	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00010 events5 affected114 at risk EG0011 events1 affected120 at risk EG0024 events4 affected119 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected114 at risk EG0014 events4 affected120 at risk EG0028 events5 affected119 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected114 at risk EG0016 events2 affected120 at risk EG0028 events7 affected119 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Colon dysplasia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00025 events18 affected114 at risk EG0014 events3 affected120 at risk EG00219 events18 affected119 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00069 events30 affected114 at risk EG00121 events15 affected120 at risk EG00256 events26 affected119 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected114 at risk EG0014 events2 affected120 at risk EG00211 events11 affected119 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00011 events9 affected114 at risk EG0010 events0 affected120 at risk EG00226 events10 affected119 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0022 events2 affected119 at risk EG003
Gastrointestinal hypermotility	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00013 events9 affected114 at risk EG0011 events1 affected120 at risk EG0028 events6 affected119 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG0022 events2 affected119 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Malocclusion	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00059 events29 affected114 at risk EG00115 events12 affected120 at risk EG00258 events26 affected119 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Pelvic floor dysfunction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Salivary gland cyst	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00034 events20 affected114 at risk EG0016 events5 affected120 at risk EG00218 events11 affected119 at risk EG003
Administration site reaction	General disorders	MedDRA 26.1	Systematic Assessment	EG0004 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Application site pruritus	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Application site reaction	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0022 events1 affected119 at risk EG003
Chest discomfort	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Discomfort	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG00222 events4 affected119 at risk EG003
Feeling cold	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0022 events1 affected119 at risk EG003
Influenza like illness	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Injection site bruising	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0022 events2 affected119 at risk EG003
Injection site erythema	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG00213 events2 affected119 at risk EG003
Injection site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Injection site pruritus	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG00213 events2 affected119 at risk EG003
Injection site rash	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Injection site reaction	General disorders	MedDRA 26.1	Systematic Assessment	EG00070 events8 affected114 at risk EG0012 events1 affected120 at risk EG00244 events6 affected119 at risk EG003
Injection site urticaria	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Local reaction	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected114 at risk EG0010 events0 affected120 at risk EG0028 events1 affected119 at risk EG003
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0022 events2 affected119 at risk EG003
Peripheral swelling	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0013 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Temperature intolerance	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0022 events2 affected119 at risk EG003
Thirst	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0022 events2 affected119 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0022 events2 affected119 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0004 events1 affected114 at risk EG0012 events2 affected120 at risk EG0021 events1 affected119 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0023 events3 affected119 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0022 events2 affected119 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Conjunctivitis viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected114 at risk EG00111 events10 affected120 at risk EG0028 events8 affected119 at risk EG003
Cystitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Dengue fever	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Ear infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Epstein-barr virus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Erysipelas	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Fungal foot infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Fungal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected114 at risk EG0014 events4 affected120 at risk EG0028 events7 affected119 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hordeolum	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected114 at risk EG0018 events8 affected120 at risk EG0023 events3 affected119 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected114 at risk EG0018 events8 affected120 at risk EG00224 events15 affected119 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Otitis externa	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Parasitic gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Paronychia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0012 events2 affected120 at risk EG0021 events1 affected119 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Rhinitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0012 events2 affected120 at risk EG0022 events2 affected119 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Tooth infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0022 events2 affected119 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00010 events7 affected114 at risk EG00111 events10 affected120 at risk EG0027 events5 affected119 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Viral infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Bone contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Breast injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Eye contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Iatrogenic injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Injection related reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Nail avulsion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected114 at risk EG0012 events2 affected120 at risk EG0022 events1 affected119 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0022 events2 affected119 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Viiith nerve injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Albumin urine present	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Amylase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0022 events1 affected119 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Blood bicarbonate increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Blood calcitonin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0013 events3 affected120 at risk EG0021 events1 affected119 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Blood glucose increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Blood osmolarity decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Blood pressure decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Blood pressure increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Blood pressure measurement	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Blood testosterone decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Blood urea increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Cardiac murmur	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Coronavirus test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Creatinine urine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Electrocardiogram t wave inversion	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Heart rate increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected114 at risk EG0012 events2 affected120 at risk EG0022 events1 affected119 at risk EG003
Lipase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected114 at risk EG0010 events0 affected120 at risk EG0025 events4 affected119 at risk EG003
Lipids abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Mean cell volume increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Occult blood positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Pancreatic enzymes increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Protein urine present	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Sars-cov-2 test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Transaminases increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Vitamin d decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Weight increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected114 at risk EG0010 events0 affected120 at risk EG0023 events3 affected119 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0013 events3 affected120 at risk EG0020 events0 affected119 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0006 events2 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0012 events2 affected120 at risk EG0021 events1 affected119 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected114 at risk EG0014 events4 affected120 at risk EG0020 events0 affected119 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected114 at risk EG0016 events6 affected120 at risk EG0024 events4 affected119 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0012 events2 affected120 at risk EG0021 events1 affected119 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Extremity contracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0016 events3 affected120 at risk EG0020 events0 affected119 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Sacroiliac joint dysfunction	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0012 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Enchondromatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Carotid arteriosclerosis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected114 at risk EG0012 events2 affected120 at risk EG0022 events1 affected119 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected114 at risk EG0016 events3 affected120 at risk EG0020 events0 affected119 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hypotonia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Lethargy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Migraine	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0020 events0 affected119 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Ophthalmic migraine	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Presyncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Sciatica	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0021 events1 affected119 at risk EG003
Somnolence	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Taste disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Tremor	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Device physical property issue	Product Issues	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0014 events4 affected120 at risk EG0021 events1 affected119 at risk EG003
Anxiety disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Bruxism	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0013 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected114 at risk EG0012 events2 affected120 at risk EG0022 events2 affected119 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Mood altered	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Rapid eye movement sleep behaviour disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Glomerulonephropathy	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hypertonic bladder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Microalbuminuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected114 at risk EG0012 events2 affected120 at risk EG0024 events3 affected119 at risk EG003
Nephropathy	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0021 events1 affected119 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected78 at risk EG0010 events0 affected79 at risk EG0020 events0 affected87 at risk EG003
Cervical cyst	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected41 at risk EG0020 events0 affected32 at risk EG003
Cervical polyp	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected41 at risk EG0021 events1 affected32 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected79 at risk EG0020 events0 affected87 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected41 at risk EG0020 events0 affected32 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0013 events3 affected120 at risk EG0021 events1 affected119 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected114 at risk EG0013 events2 affected120 at risk EG0023 events3 affected119 at risk EG003
Diaphragmatic disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0024 events4 affected119 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Tonsillar inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Vasomotor rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected114 at risk EG0011 events1 affected120 at risk EG0025 events5 affected119 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Sebaceous hyperplasia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Cochlea implant	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Fascia release	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Intraocular lens implant	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Phlebectomy	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Ureteral stent insertion	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Aortic occlusion	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Haematoma	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0019 events8 affected120 at risk EG0022 events2 affected119 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Internal haemorrhage	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003

ID	Term
D020181	Sleep Apnea, Obstructive
D009765	Obesity

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000067757	Glucagon-Like Peptide-1 Receptor
D000067756	Glucagon-Like Peptide Receptors
D043562	Receptors, G-Protein-Coupled
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011964	Receptors, Gastrointestinal Hormone
D018000	Receptors, Peptide

ID	Title	Description
BG000	Tirzepatide MTD_GPI1	Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
BG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
BG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
BG003	Placebo_GPI2	Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tirzepatide MTD_GPI1	Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.	114	9	114	91	114
EG001	Placebo_GPI1	Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.	120	7	120	91	120
EG002	Tirzepatide MTD_GPI2	Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.	119	7	119	98	119
EG003	Placebo_GPI2	Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.	114	12	114	82	114

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG0031 events1 affected114 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0012 events2 affected120 at risk EG0021 events1 affected119 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Appendicitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Dengue fever	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Loose body in joint	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected78 at risk EG0010 events0 affected79 at risk EG0020 events0 affected87 at risk EG003
Tonsil cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected120 at risk EG0020 events0 affected119 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Coma	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Presyncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Mood swings	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0021 events1 affected119 at risk EG003
Abnormal uterine bleeding	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected41 at risk EG0020 events0 affected32 at risk EG003
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Nephrectomy	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected120 at risk EG0020 events0 affected119 at risk EG003