A Study to Evaluate the Effect of Dapagliflozin With and... | NCT02547935

NCT02547935

Status Module

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
Dapagliflozin 10mg	Experimental	Tablets administered orally once daily for 24 weeks	Drug: Dapagliflozin 10 mg
Dapagliflozin 10mg + Saxagliptin 2.5mg	Experimental	Tablets administered orally once daily for 24 weeks	Drug: Saxagliptin 2.5 mg
Placebo	Placebo Comparator	Tablets administered orally once daily for 24 weeks	Drug: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin 10 mg	Drug	Tablets administered orally once daily for 24 weeks.	Dapagliflozin 10mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24	HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model.	Baseline and Week 24
Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24	UACR was analysed at baseline and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. UACR values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.	Baseline and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24	Total body weight was measured in kilograms (kg) at baseline and at Week 1 then every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. Total body weight values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Peoria	Arizona	85381	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38770818	Derived	Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
38017482

Label	URL
D1690c00023\_CSP\_Redacted	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 milligram (mg) and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
FG001	Dapagliflozin 10 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	Sep 18, 2017	May 15, 2019

Arm/Group Information

ID	Title	Description
BG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
BG001	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
BG002	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 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

Title	Measurements
	BG00064.0± 9.21 BG00164.7± 8.61 BG00264.7± 8.53 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<65 years	BG00078 BG00164 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00045 BG00143 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00042 BG00132 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG00077 BG00155 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 From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24

HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model.

Patients from the Full Analysis Set (all randomised patients who took at least 1 dose of double-blind study drug and had a non missing baseline value and at least one post-baseline efficacy variable value) with non-missing baseline and Week 24 values for HbA1c.

Posted

Least Squares Mean

Standard Error

Percentage of Glycoslyated HbA1c

Baseline and Week 24

ID	Title	Description
OG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
OG001	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.

Units	Counts
Participants	OG000151 OG001145

Title

Denominators

Categories

Title	Measurements
	OG000-0.85± 0.09 OG001-0.27± 0.09

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	A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.	MMRM		<0.001	Statistical significance level = 0.025.	Difference in adjusted mean change	-0.58	Standard Error of the Mean	0.11	2-Sided	95	-0.80	-0.37					Superiority

Primary

Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24

UACR was analysed at baseline and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. UACR values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.

Patients from the Full Analysis Set with non-missing baseline and Week 24 values for UACR.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline and Week 24

ID	Title	Description
OG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
OG001	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
OG002	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.

Secondary

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

Total body weight was measured in kilograms (kg) at baseline and at Week 1 then every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. Total body weight values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.

Patients from the Full Analysis Set with non-missing baseline and Week 24 values for total body weight.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline and Week 24

ID	Title	Description
OG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
OG001	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
OG002	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.

Secondary

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

FPG was analysed at baseline and Week 1 then every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.

Patients from the Full Analysis Set with non-missing baseline and Week 24 values for FPG.

Posted

Least Squares Mean

Standard Error

mg/decilitre (dL)

Baseline and Week 24

ID	Title	Description
OG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
OG001	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
OG002	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.

Secondary

Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24

The percentage of patients meeting the criteria of at least a 30% reduction in UACR, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (Last Observation Carried Forward [LOCF]).

Patients from the Full Analysis Set with non-missing baseline and at least one post-baseline UACR value.

Posted

Number

Percentage of patients

From baseline up to Week 24

ID	Title	Description
OG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
OG001	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
OG002	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.

Secondary

Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24

The percentage of patients meeting the criteria of a less than 7% reduction in HbA1c, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (LOCF). Only measurements prior to rescue or treatment discontinuation were analysed.

Patients from the Full Analysis Set with non-missing baseline and at least one post-baseline HbA1c value.

Posted

Number

Percentage of patients

From baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
OG001	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
OG002	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.

Secondary

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24

Seated SBP was analysed at baseline, Week 1 and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.

Patients from the Full Analysis Set with non-missing baseline and Week 24 values for SBP.

Posted

Least Squares Mean

Standard Error

Millimetre of mercury (mmHg)

Baseline and Week 24

ID	Title	Description
OG000	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.
OG001	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
OG002	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.

Secondary

Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24

Patients from the Full Analysis Set with non-missing baseline and Week 24 values for HbA1c.

Posted

Least Squares Mean

Standard Error

Percentage of Glycoslyated HbA1c

Baseline and Week 24

ID	Title	Description
OG000	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.
OG001	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin) were taken orally, once daily (in the morning) for 24 weeks.

Units	Counts
Participants	OG000

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 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg and saxagliptin 2.5 mg tablets were taken orally, once daily (in the morning) for 24 weeks.	1	152	12	152	12	152
EG001	Dapagliflozin 10 mg	Dapagliflozin 10 mg tablets were taken orally, once daily (in the morning) for 24 weeks. Patients also took placebo tablets to match saxagliptin.	1	145	12	145	18	145
EG002	Placebo	Placebo tablets to match both active products (dapagliflozin and saxagliptin)were taken orally, once daily (in the morning) for 24 weeks.	0	148	16	148	8	148

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0022 events2 affected148 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0022 events2 affected148 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Diabetic foot infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Emphysematous pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Genital infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Groin abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0022 events2 affected148 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0023 events2 affected148 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected145 at risk EG0020 events0 affected148 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0022 events2 affected148 at risk
Glomerulonephritis rapidly progressive	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected145 at risk EG0020 events0 affected148 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected145 at risk EG0020 events0 affected148 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected145 at risk EG0021 events1 affected148 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
D011507	Proteinuria
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003924	Diabetes Mellitus, Type 2
D000419	Albuminuria

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected152 at risk EG0018 events8 affected145 at risk EG0022 events2 affected148 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG00012 events10 affected152 at risk EG00111 events10 affected145 at risk EG0026 events6 affected148 at risk