Safety and Efficacy Study of Sotagliflozin on Glucose Con... | NCT03242252

NCT03242252

ID	Type	Description	Link
2016-004889-26
U1111-1187-8662	Other Identifier	UTN

Status Module

Name	Class
Sanofi	INDUSTRY

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
Placebo	Placebo Comparator	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Drug: Placebo
Sotagliflozin 200 mg	Experimental	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Drug: Placebo Drug: Sotagliflozin
Sotagliflozin 400 mg	Experimental	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.	Drug: Sotagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily. Route of administration: Oral	Placebo Sotagliflozin 200 mg

Outcomes Module

Measure	Description	Time Frame
Change From Baseline in HbA1c at Week 26	An Analysis of covariance (ANCOVA) model was used for analysis.	Baseline to Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	An ANCOVA model was used for analysis.	Baseline to Week 26
Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants With Hypoglycemic Events	Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].

Eligibility Module

Name	Affiliation	Role
Suman Wason, MD	Lexicon Pharmaceuticals, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 8404018		Birmingham	Alabama	35205	United States
Investigational Site Number 8404045

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36782093	Derived	Cherney DZI, Ferrannini E, Umpierrez GE, Peters AL, Rosenstock J, Powell DR, Davies MJ, Banks P, Agarwal R. Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease. Diabetes Obes Metab. 2023 Jun;25(6):1646-1657. doi: 10.1111/dom.15019. Epub 2023 Feb 28.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
FG001	Sotagliflozin 200 mg

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 22, 2017	Apr 12, 2021

Arm/Group Information

ID	Title	Description
BG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
BG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
BG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000260 ParticipantsBG001263 ParticipantsBG002264 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000260 ParticipantsBG001263 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000260 ParticipantsBG001263 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000260 ParticipantsBG001263 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
Colombia	ParticipantsBG000260 ParticipantsBG001263 ParticipantsBG002

Hemoglobin A1c (HbA1c)

Number analyzed specifies the number of participants evaluated for the parameter.

Mean

Standard Deviation

percentage of HbA1c

Title	Denominators	Categories
	ParticipantsBG000260 ParticipantsBG001262 ParticipantsBG002

Systolic Blood Pressure (SBP)

Mean

Standard Deviation

millimeter of mercury (mmHg)

Title	Denominators	Categories
	ParticipantsBG000260 ParticipantsBG001263 ParticipantsBG002

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 HbA1c at Week 26

An Analysis of covariance (ANCOVA) model was used for analysis.

Intent-to-treat (ITT) population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using control-based copy reference multiple imputation under the missing not at random framework.

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

Baseline to Week 26

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
OG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Units	Counts
Participants	OG000260 OG001263 OG002264

Title

Denominators

Categories

Title	Measurements
	OG000-0.22± 0.061 OG001-0.32± 0.060 OG002-0.46± 0.060

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	The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, >8.5%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, randomization stratum of Chronic Kidney Disease (CKD) stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.	ANCOVA		0.2095		Difference in Least Squares (LS) Means	-0.1	Standard Error of the Mean	0.076	2-Sided	95	-0.245	0.054					Superiority

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

An ANCOVA model was used for analysis.

ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts & washout imputation method.

Posted

Least Squares Mean

Standard Error

millimole per liter (mmol/L)

Baseline to Week 26

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
OG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Secondary

Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12

An ANCOVA model was used for analysis.

Analysis population included participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts & washout imputation method.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
OG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Secondary

Change From Baseline in SBP at Week 12 for All Participants

An ANCOVA model was used for analysis.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
OG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Secondary

Change From Baseline in Body Weight at Week 26

An ANCOVA model was used for analysis.

Posted

Least Squares Mean

Standard Error

kilogram (kg)

Baseline to Week 26

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
OG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Secondary

Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)

An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.

Analysis population included participants with baseline UACR >30 mg/g in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using control-based copy reference multiple imputation under the missing not at random framework.

Posted

Geometric Mean

Standard Error

percent change

Baseline to Week 26

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
OG002	Sotagliflozin 400 mg

Secondary

Percentage of Participants With HbA1c <6.5% at Week 26

ITT population included all randomized participants or participants analyzed according to their randomized treatment.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
OG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Units	Counts

Secondary

Percentage of Participants With HbA1c <7.0% at Week 26

ITT population included all randomized participants or participants analyzed according to their randomized treatment.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
OG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Units	Counts

Secondary

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.

Posted

Number

percentage of participants

Up to 60 weeks

ID	Title	Description
OG000	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.
OG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.

Other Pre-specified

Percentage of Participants With Hypoglycemic Events

Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].

Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.

Posted

Number

percentage of participants

Up to 60 weeks

ID	Title	Description
OG000	Placebo	Following a 2-week run-in phase, participants received two placebo tablets (identical to Sotagliflozin 200 mg in appearance), orally once daily for up to 54 weeks.
OG001	Sotagliflozin 200 mg	Following a 2-week run-in phase, participants received two tablets, 1 Sotagliflozin 200 mg tablet and 1 placebo tablet (identical to Sotagliflozin 200 mg in appearance), orally once daily for up to 58 weeks. Four participants randomized to Sotagliflozin 400 mg were dosed with both Sotagliflozin 200 mg and 400 mg. These participants were included in the Sotagliflozin 200 mg arm in the safety population.

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	Placebo	Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	3	260	48	260	80	260
EG001	Sotagliflozin 200 mg	Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.	2	267	43	267	72	267
EG002	Sotagliflozin 400 mg	Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.	5	260	44	260	77	260

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Extremity necrosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0012 affected267 at risk EG0020 affected260 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0022 affected260 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0003 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Malignant melanoma of eyelid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Uterine neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Cardiac death	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Non-cardiac chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Peripheral swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Delirium	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Panic attack	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0021 affected260 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Procedural shock	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Blood pressure increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected260 at risk EG0012 affected267 at risk EG0022 affected260 at risk
Angina pectoris	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Angina unstable	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0014 affected267 at risk EG0021 affected260 at risk
Arrhythmia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Atrial flutter	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Cardiac arrest	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0022 affected260 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Coronary artery disease	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0011 affected267 at risk EG0023 affected260 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Pericarditis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0013 affected267 at risk EG0021 affected260 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Embolic stroke	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Hemiparesis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0012 affected267 at risk EG0021 affected260 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected260 at risk EG0012 affected267 at risk EG0020 affected260 at risk
Loss of consciousness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Glaucoma	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Iris neovascularisation	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0022 affected260 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0012 affected267 at risk EG0020 affected260 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0022 affected260 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0022 affected260 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Renal impairment	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Urinary retention	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Liver injury	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected260 at risk EG0011 affected267 at risk EG0021 affected260 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0011 affected267 at risk EG0021 affected260 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0011 affected267 at risk EG0022 affected260 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Abscess limb	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Appendicitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0012 affected267 at risk EG0020 affected260 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0011 affected267 at risk EG0021 affected260 at risk
Corneal abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Enterococcal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Funguria	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Gangrene	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Infective periostitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0010 affected267 at risk EG0020 affected260 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected260 at risk EG0012 affected267 at risk EG0021 affected260 at risk
Sepsis pasteurella	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Septic shock	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Tick-borne viral encephalitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0013 affected267 at risk EG0020 affected260 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Wound infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0011 affected267 at risk EG0020 affected260 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected260 at risk EG0010 affected267 at risk EG0021 affected260 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00013 affected260 at risk EG00115 affected267 at risk EG00222 affected260 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00030 affected260 at risk EG00124 affected267 at risk EG00224 affected260 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00013 affected260 at risk EG0017 affected267 at risk EG00212 affected260 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00018 affected260 at risk EG00116 affected267 at risk EG00213 affected260 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00021 affected260 at risk EG00119 affected267 at risk EG00221 affected260 at risk

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003924	Diabetes Mellitus, Type 2
D051436	Renal Insufficiency, Chronic