Dapagliflozin Evaluation in Patients With Inadequately Co... | NCT02268214

ID	Type	Description	Link
2013-004674-97	EudraCT Number
D1695C00006	Other Identifier	AstraZenenca

Status Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight 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
Arm A: Dapagliflozin	Experimental	Dapagliflozin 5 mg tablet orally, once daily for 52 weeks	Drug: Dapagliflozin
Arm B: Dapagliflozin	Experimental	Dapagliflozin 10 mg tablet orally, once daily for 52 weeks	Drug: Dapagliflozin
Arm C: Placebo for Dapagliflozin	Placebo Comparator	Placebo tablet orally, once daily for 52 weeks	Drug: Placebo for dapagliflozin

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	Tablets	Arm A: Dapagliflozin Arm B: Dapagliflozin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change in HbA1c From Baseline at Week 24	Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).	From Baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24	Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])	From Baseline to Week 24
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24

Eligibility Module

Name	Affiliation	Role
Anna Maria Langkilde	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Little Rock	Arkansas	72205	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39918875	Derived	Nardone M, Kugathasan L, Sridhar VS, Dutta P, Campbell DJT, Layton AT, Perkins BA, Barbour S, Lam TKT, Levin A, Lovblom LE, Mucsi I, Rabasa-Lhoret R, Rac VE, Senior P, Sigal RJ, Stanimirovic A, Persson F, Stougaard EB, Doria A, Cherney DZI. Modeling Cardiorenal Protection with Sodium-Glucose Cotransporter 2 Inhibition in Type 1 Diabetes: An Analysis of DEPICT-1 and DEPICT-2. Clin J Am Soc Nephrol. 2025 Apr 1;20(4):529-538. doi: 10.2215/CJN.0000000641. Epub 2025 Feb 7.
38770818

Label	URL
MB102229\_CSP	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
FG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
BG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin
BG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin
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

Title	Measurements
	BG00042.1± 13.94 BG00143.4± 13.89 BG00242.7± 13.57 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 65 years	BG000262 BG001279 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000158 BG001144 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

Adjusted Mean Change in HbA1c From Baseline at Week 24

Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).

All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.

Posted

Least Squares Mean

Standard Error

Percentage of hemoglobin

From Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
OG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin
OG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin

Units	Counts
Participants	OG000254 OG001254 OG002257

Title

Denominators

Categories

Title	Measurements
	OG000-0.45± 0.0537 OG001-0.47± 0.0538 OG002-0.03± 0.0540

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 OG002		RMM	Repeated Measures Model	<0.0001		Mean Difference (Final Values)	-0.42	Standard Error of the Mean	0.0697	2-Sided	95	-0.56	-0.28					Superiority
OG001 OG002		RMM

Secondary

Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24

Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])

Posted

Least Squares Mean

Standard Error

From Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
OG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin
OG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin

Units	Counts
Participants

Secondary

Adjusted Mean Percent Change in Body Weight From Baseline at Week 24

Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM])

Posted

Least Squares Mean

Standard Error

From Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
OG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin
OG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin

Units	Counts
Participants

Secondary

Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24

Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM])

Posted

Least Squares Mean

Standard Error

mg/dL

From Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
OG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin
OG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin

Units	Counts

Secondary

Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24

Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model[RMM])

Posted

Least Squares Mean

Standard Error

mg/dL

From Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
OG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin
OG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin

Units	Counts

Secondary

Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24

Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model[RMM])

Posted

Least Squares Mean

Standard Error

Percentage

From Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
OG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin
OG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin

Units

Secondary

Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events

Subjects with HbA1c reduction from baseline to week 24 (LOCF) >= 0.5% and without severe hypoglycemia events

Posted

Count of Participants

Participants

From Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin
OG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin
OG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin

Units	Counts

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	Dapagliflozin 5 mg + Insulin	Dapagliflozin 5 mg oral tablet once daily + background insulin	0	277	37	277	123	277
EG001	Dapagliflozin 10 mg + Insulin	Dapagliflozin 10 mg oral tablet once daily + background insulin	0	296	40	296	118	296
EG002	Placebo + Insulin	Placebo oral tablet once daily + background insulin	1	260	30	260	99	260

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Sinus tachycardia	Cardiac disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Blindness unilateral	Eye disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Cataract	Eye disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Vitreous haemorrhage	Eye disorders	MedDRA Version 20.0	Systematic Assessment	EG0003 events2 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Chest pain	General disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0012 events2 affected296 at risk EG0021 events1 affected260 at risk
Impaired healing	General disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Ophthalmoplegia	Eye disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Oesophagitis haemorrhagic	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Pyrexia	General disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Cyclic vomiting syndrome	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0002 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Hepatic haematoma	Hepatobiliary disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Abscess limb	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Bronchitis	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Cellulitis	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Chronic sinusitis	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Influenza	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Localised infection	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Nasal abscess	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Perineal abscess	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Peritonsillar abscess	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Pneumonia	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Tooth infection	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0002 events1 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Urosepsis	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0012 events1 affected296 at risk EG0020 affected260 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0022 events2 affected260 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0021 events1 affected260 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Liver function test increased	Investigations	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 20.0	Systematic Assessment	EG00011 events10 affected277 at risk EG0017 events7 affected296 at risk EG0023 events3 affected260 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 20.0	Systematic Assessment	EG0002 events2 affected277 at risk EG0014 events4 affected296 at risk EG0024 events3 affected260 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 20.0	Systematic Assessment	EG0002 events2 affected277 at risk EG0014 events4 affected296 at risk EG0020 affected260 at risk
Ketosis	Metabolism and nutrition disorders	MedDRA Version 20.0	Systematic Assessment	EG0002 events2 affected277 at risk EG0012 events2 affected296 at risk EG0020 affected260 at risk
Obesity	Metabolism and nutrition disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Cubital tunnel syndrome	Nervous system disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Multiple sclerosis	Nervous system disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Adjustment disorder	Psychiatric disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Renal colic	Renal and urinary disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA Version 20.0	Systematic Assessment	EG0001 events1 affected277 at risk EG0010 affected296 at risk EG0020 affected260 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Embolism	Vascular disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0010 affected296 at risk EG0021 events1 affected260 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0011 events1 affected296 at risk EG0020 affected260 at risk
Thrombosis	Vascular disorders	MedDRA Version 20.0	Systematic Assessment	EG0000 affected277 at risk EG0012 events1 affected296 at risk EG0020 affected260 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG00013 events11 affected277 at risk EG00125 events21 affected296 at risk EG00210 events9 affected260 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 20.0	Systematic Assessment	EG00018 events14 affected277 at risk EG00120 events15 affected296 at risk EG0027 events7 affected260 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG00016 events15 affected277 at risk EG00113 events10 affected296 at risk EG00210 events8 affected260 at risk
Influenza	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG00018 events15 affected277 at risk EG00117 events15 affected296 at risk EG00223 events17 affected260 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG00026 events19 affected277 at risk EG00136 events28 affected296 at risk EG00228 events15 affected260 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG00037 events27 affected277 at risk EG00112 events10 affected296 at risk EG00220 events19 affected260 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA Version 20.0	Systematic Assessment	EG00067 events51 affected277 at risk EG00165 events46 affected296 at risk EG00266 events48 affected260 at risk
Headache	Nervous system disorders	MedDRA Version 20.0	Systematic Assessment	EG00017 events14 affected277 at risk EG00127 events20 affected296 at risk EG00213 events13 affected260 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases