A Research Study to Compare Two Doses of Semaglutide Take... | NCT03989232

ID	Type	Description	Link
U1111-1224-5162	Other Identifier	World Health Organization (WHO)
2018-004529-96	Registry Identifier	European Medicines Agency (EudraCT)

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Semaglutide 2.0 mg	Experimental	All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.	Drug: Semaglutide
Semaglutide 1.0 mg	Active Comparator	All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.	Drug: Semaglutide Drug: Placebo (semaglutide)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.	Semaglutide 1.0 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c	Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.	Week 0, week 40

Secondary Outcomes

Measure	Description	Time Frame
Change in Body Weight	Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.

Eligibility Module

Name	Affiliation	Role
Clinical Reporting Anchor and Disclosure (1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Birmingham	Alabama	35205	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34293304	Result	Frias JP, Auerbach P, Bajaj HS, Fukushima Y, Lingvay I, Macura S, Sondergaard AL, Tankova TI, Tentolouris N, Buse JB. Efficacy and safety of once-weekly semaglutide 2.0 mg versus 1.0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):563-574. doi: 10.1016/S2213-8587(21)00174-1. Epub 2021 Jul 21.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 8, 2020	Aug 4, 2021

Arm/Group Information

ID	Title	Description
BG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
BG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00058.2± 9.9 BG00157.9± 10.0 BG00258.0± 10.0

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000197 BG001201 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00059 BG00152 BG002

Race/Ethnicity, Customized

Race

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska native	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in HbA1c

Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated.

Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.

The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.

Posted

Mean

Standard Deviation

Percentage change

Week 0, week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Units	Counts
Participants	OG000481 OG001480

Title

Denominators

Categories

On-treatment without rescue medication

- ParticipantsOG000422
- ParticipantsOG001423

Title	Measurements
	OG000-2.0± 1.0

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	On-treatment without rescue medication observation period: Imputation of missing data was handled by multiple imputation (MI) assuming that missing data were missed at random (MAR). The imputation was performed separately within each treatment group defined by randomised treatment.	ANCOVA		0.0003		Treatment difference	-0.23			2-Sided	95	-0.36	-0.11					Superiority

Secondary

Change in Body Weight

Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.

The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.

Posted

Mean

Standard Deviation

Kilogram (kg)

Week 0, week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Secondary

Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.

The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Posted

Mean

Standard Deviation

Millimoles per liter (mmol/L)

Week 0, week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Secondary

Change in Body Mass Index (BMI)

Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.

The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Posted

Mean

Standard Deviation

Kilogram per squaremeter (Kg/m^2)

Week 0, week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Secondary

Change in Waist Circumference

Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.

The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Posted

Mean

Standard Deviation

Centimeter (cm)

Week 0, week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Secondary

Participants Who Achieved HbA1c < 7.0%

Percentage of participants who achieved HbA1c < 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.

The FAS included all randomized participants.

Posted

Number

Percentage of participants

Week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Secondary

Participants Who Achieved HbA1c ≤ 6.5%

Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.

The FAS included all randomized participants.

Posted

Number

Percentage of participants

Week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Secondary

Participants Who Achieved Weight Loss ≥5%

Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.

The FAS included all randomized participants.

Posted

Number

Percentage of participants

Week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Secondary

Participants Who Achieved Weight Loss ≥10%

Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.

The FAS included all randomized participants.

Posted

Number

Percentage of participants

Week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Secondary

Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.

The SAS included all participants exposed to at least one dose of trial product.

Posted

Number

Episodes

Week 0 to week 47

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg

Secondary

Change in Pulse Rate

Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.

The SAS included all participants exposed to at least one dose of trial product. Overall number of participants analyzed=number of participants contributed to the analysis.

Posted

Mean

Standard Deviation

Beats per minute

Week 0, week 40

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
OG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Semaglutide 1.0 mg	Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.	1	480	25	480	126	480
EG001	Semaglutide 2.0 mg	Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.	2	479	21	479	132	479

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected480 at risk EG0012 events2 affected479 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected480 at risk EG0011 events1 affected479 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Angina pectoris	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Aortic dilatation	Vascular disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Aortic dissection	Vascular disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0012 events1 affected479 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Chest discomfort	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Colitis	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Constipation	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Coronary artery disease	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0011 events1 affected479 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0003 events3 affected480 at risk EG0010 events0 affected479 at risk
Death; reason unknown	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected480 at risk EG0010 events0 affected479 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Gangrene	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Hypertensive crisis	Vascular disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected480 at risk EG0010 events0 affected479 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Migraine	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Nausea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Neuromyelitis optica spectrum disorder	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Pneumonia viral	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Smear cervix abnormal	Investigations	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0003 events1 affected480 at risk EG0010 events0 affected479 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Transaminases increased	Investigations	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected480 at risk EG0011 events1 affected479 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk
Weight decreased	Investigations	MedDRA 23	Systematic Assessment	EG0001 events1 affected480 at risk EG0010 events0 affected479 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG00018 events18 affected480 at risk EG00129 events29 affected479 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00083 events42 affected480 at risk EG00151 events45 affected479 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00026 events25 affected480 at risk EG00117 events16 affected479 at risk
Nausea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00098 events70 affected480 at risk EG00198 events69 affected479 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00040 events32 affected480 at risk EG00155 events37 affected479 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases