An Efficacy, Safety, and Tolerability Study of Canagliflo... | NCT01064414 | Trialant
NCT01064414
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Aug 14, 2013Estimated
Enrollment
272Actual
Phase
Phase 3
Conditions
Diabetes Mellitus, Type 2
Renal Insufficiency
Interventions
Canagliflozin
Placebo
Countries
United States
Australia
Belgium
Brazil
Canada
France
Germany
India
Latvia
Malaysia
Mexico
New Zealand
Poland
Romania
Russia
South Africa
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT01064414
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR017008
Secondary IDs
ID
Type
Description
Link
28431754DIA3004
Other Identifier
Janssen Research & Development, LLC
Brief Title
An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Official Title
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Aug 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2010
Primary Completion Date
Dec 2011Actual
Completion Date
Aug 2012Actual
First Submitted Date
Feb 4, 2010
First Submission Date that Met QC Criteria
Feb 4, 2010
First Posted Date
Feb 8, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 2, 2013
Results First Submitted that Met QC Criteria
Apr 2, 2013
Results First Posted Date
May 27, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 27, 2012
Certification/Extension First Submitted that Passed QC Review
Jun 27, 2012
Certification/Extension First Posted Date
Apr 25, 2012Estimated
Last Update Submitted Date
Aug 2, 2013
Last Update Posted Date
Aug 14, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.
Detailed Description
This is a randomized (study drug assigned by chance), double blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of 2 different doses of canagliflozin (100 mg and 300 mg) compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with type 2 diabetes mellitus (T2DM) who have renal impairment (reduced kidney function) and who are not achieving an adequate response from current therapy to control their diabetes. Canagliflozin (also referred to as JNJ-28431754) is a drug that is being tested to see if it may be useful in treating patients diagnosed with T2DM. Approximately 240 patients will participate in the study for approximately 63 to 72 weeks, depending on the length of the pretreatment phase. The study will consist of a pretreatment phase, a 52 week double blind treatment phase, and a posttreatment phase. During the pretreatment phase, screening evaluations will be performed to see if patients meet the entry criteria for the study. In addition, routine clinical procedures will be performed (physical examination, vital signs measurements, and an electrocardiogram [ECG]), a blood and urine sample will be collected for routine clinical laboratory tests, and all antihyperglycemic therapy taken by patients will be reviewed. Patients who meet entrance criteria for the study and who currently take a stable antihyperglycemic agent (AHA) regimen according to the local prescribing information will be eligible for inclusion in the study. Patients who meet entrance criteria for the study but who are not taking a stable AHA regimen according to the local prescribing information will enter an AHA adjustment period that may last for up to 12 weeks. Patients will receive once daily treatment with study drug in addition to their current stable diabetes regimen (eg, diet, exercise, and medication therapy). Patients will continue to take their assigned treatment for 52 weeks (includes a 26-week core double-blind treatment period and a 26-week extension double-blind treatment period). During the study, if a patient's blood sugar remains high despite treatment with study drug in combination with their other antidiabetic agents, the study physician will modify the patient's treatment. If patients take insulin and experience low blood sugar (hypoglycemia), the dose of insulin may be modified. During the study, patients will be monitored for safety by review of adverse events, results from safety laboratory tests (including chemistry, hematology, and urinalysis), ECGs, vital signs measurements, body weight, physical examinations, self-monitored blood glucose, and collection of potential hypoglycemic episodes reported by patients on diary cards. The safety of patients in this study will also be monitored by a company internal Medical Safety Review Committee (MSRC). An Independent Data Monitoring Committee (IDMC) will evaluate cardiovascular (CV) events that are reported across the entire clinical development program for canagliflozin. Patients who complete the Week 52 visit or who discontinue treatment early and are withdrawn from the study will have end-of-study evaluations performed and a follow-up telephone interview conducted by study personnel approximately 30 days (but no more than 42 days) after the last dose of study drug to collect any serious adverse events that occurred since their last study visit. The primary outcome measures in the study are to assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c, a blood test used to measure the control of diabetes) after 26 weeks of treatment and to assess the safety and tolerability of canagliflozin from time of signed informed consent to study end (includes up to 30 days following the last dose of study drug). All patients will take a single-blind placebo capsule once daily for 2 weeks before randomization to double-blind study drug. After randomization, patients will take one capsule of canagliflozin (either 100 mg or 300 mg) or matching placebo orally (by mouth) with liquid once daily for 52 weeks before the first meal each day except on days when fasting or pharmacokinetic blood samples are collected in which case study drug will be taken after the visit immediately before the patient's next meal.
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Renal Insufficiency
Keywords
Canagliflozin
JNJ 28431754
Placebo
Sodium-Glucose Transporter 2
hemoglobin A1c protein, Blood Glucose
reduced kidney function, Type 2 diabetes mellitus
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
272Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Canagliflozin 100 mg
Experimental
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks.
Drug: Canagliflozin
Canagliflozin 300 mg
Experimental
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks.
Drug: Canagliflozin
Placebo
Placebo Comparator
Each patient will receive matching placebo once daily for 52 weeks.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Canagliflozin
Drug
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in HbA1c From Baseline to Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Patients With HbA1c <7% at Week 26
The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non oral agents)
Patients with reduced kidney function
Exclusion Criteria:
History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
Kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease
Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen
History of a severe hypoglycemic episode within 6 months before screening
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
25 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC C. Clinical Trial
Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.
Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
272 patients were randomly allocated to the 3 treatment arms. 269 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented in two parts: for Baseline to Week 26 as "Core Period", and for Week 26 to Week 52 as "Extension Period".
Recruitment Details
This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus and moderate renal impairment. The study was conducted between 02 March 2010 and 19 January 2012 and recruited patients from 89 study centers located in 19 countries worldwide.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
One matching placebo capsule orally once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
Placebo
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
FG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
FG00090 subjects
FG00190 subjects
FG00289 subjects
COMPLETED
FG00077 subjects
FG00175 subjects
FG00282 subjects
NOT COMPLETED
FG00013 subjects
FG00115 subjects
FG0027 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0014 subjects
FG0022 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0021 subjects
Withdrawal by Subject
FG0004 subjects
FG0012 subjects
FG0022 subjects
Noncompliance with study drug
FG0000 subjects
FG0011 subjects
FG0020 subjects
Other
FG0004 subjects
FG0017 subjects
FG0022 subjects
Extension Period: Week 26 to Week 52
Type
Comment
Milestone Data
STARTED
FG00076 subjects1 pt completed core but did not enter ext. Reason: other (not specified).
FG00172 subjects3 pts completed core but did not enter ext. Reason: other (not specified) (3).
FG00281 subjects1 pt completed core but did not enter ext. Reason: other (not specified).
COMPLETED
FG00064 subjects
FG00167 subjects
FG00276 subjects
NOT COMPLETED
FG00012 subjects
FG0015 subjects
FG0025 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0022 subjects
Death
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Each patient received matching placebo once daily for 52 weeks.
BG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 52 weeks.
BG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 52 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00090
BG00190
BG00289
BG003269
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00068.2± 8.4
BG00169.5± 8.2
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00033
BG00132
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
AUSTRALIA
Title
Measurements
BG0003
BG0016
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in HbA1c From Baseline to Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 52 weeks.
OG001
Canagliflozin 100 mg
Each patient received canagliflozin 100 mg once daily for 52 weeks.
OG002
Canagliflozin 300 mg
Each patient received canagliflozin 300 mg once daily for 52 weeks.
Units
Counts
Participants
OG00087
OG00188
OG00289
Title
Denominators
Categories
Title
Measurements
OG000-0.03± 0.090
OG001-0.33± 0.090
OG002-0.44± 0.089
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.012
Least-Squares Mean Difference
-0.30
Standard Error of the Mean
0.117
2-Sided
95
-0.529
-0.066
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Secondary
Percentage of Patients With HbA1c <7% at Week 26
The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Number
Percentage of patients
Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 52 weeks.
OG001
Canagliflozin 100 mg
Each patient received canagliflozin 100 mg once daily for 52 weeks.
OG002
Canagliflozin 300 mg
Each patient received canagliflozin 300 mg once daily for 52 weeks.
Secondary
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
mg/dL
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 52 weeks.
OG001
Canagliflozin 100 mg
Each patient received canagliflozin 100 mg once daily for 52 weeks.
OG002
Canagliflozin 300 mg
Each patient received canagliflozin 300 mg once daily for 52 weeks.
Time Frame
Adverse events data were collected for the duration of study (52 weeks).
Description
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
All-Cause Mortality Comment
Not provided
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: Baseline to Week 26
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26.
16
90
27
90
EG001
Canagliflozin 100 mg: Baseline to Week 26
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
10
90
21
90
EG002
Canagliflozin 300 mg: Baseline to Week 26
Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
10
89
33
89
EG003
Placebo: Baseline to Week 52
Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 52.
24
90
46
90
EG004
Canagliflozin 100 mg: Baseline to Week 52
Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
18
90
46
90
EG005
Canagliflozin 300 mg: Baseline to Week 52
Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
21
89
48
89
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG0030 affected90 at risk
EG004
Acute coronary syndrome
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Cardiac arrest
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Coronary artery disease
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Myocardial infarction
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Glaucoma
Eye disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Appendicitis perforated
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Campylobacter intestinal infection
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, this event was coded as "campylobacter intestinal infection"; it was subsequently re-coded in the Week 52 study report as "campylobacter gastroenteritis".
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Infected skin ulcer
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0002 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Sepsis
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Septic shock
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Splenic rupture
Injury, poisoning and procedural complications
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Blood creatinine increased
Investigations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Troponin increased
Investigations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Bladder neck obstruction
Renal and urinary disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Renal artery stenosis
Renal and urinary disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Renal failure
Renal and urinary disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Renal failure acute
Renal and urinary disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0021 affected89 at risk
EG003
Renal impairment
Renal and urinary disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected89 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Arteritis
Vascular disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Deep vein thrombosis
Vascular disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Femoral arterial stenosis
Vascular disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Hypertension
Vascular disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Hypotension
Vascular disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Coronary artery insufficiency
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Cor pulmonale
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Cardiac failure acute
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Angina pectoris
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Angina unstable
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Atrial fibrilation
Cardiac disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Cataract
Eye disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Non-cardiac chest pain
General disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Oedema peripheral
General disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Appendicitis
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Cellulitis
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Gastroenteritis
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Lobar pneumonia
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Cerebral infarction
Nervous system disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Neophrolithiasis
Renal and urinary disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Urinary retention
Renal and urinary disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0021 affected89 at risk
EG003
Skin necrosis
Skin and subcutaneous tissue disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, this event was coded as "campylobacter intestinal infection"; it was subsequently re-coded in the Week 52 study report as "campylobacter gastroenteritis".
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Diabetic complications
Metabolism and nutrition disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected89 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0005 affected90 at risk
EG0013 affected90 at risk
EG0024 affected89 at risk
EG0039 affected90 at risk
EG004
Nasopharyngitis
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG00010 affected90 at risk
EG0013 affected90 at risk
EG0027 affected89 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0005 affected90 at risk
EG0014 affected90 at risk
EG0027 affected89 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0004 affected90 at risk
EG00113 affected90 at risk
EG00210 affected89 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, 1 patient (placebo) had vitamin D deficiency recorded in error by the investigator which was corrected in the Week 52 study report.
EG0005 affected90 at risk
EG0010 affected90 at risk
EG0021 affected89 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0005 affected90 at risk
EG0010 affected90 at risk
EG0022 affected89 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0025 affected89 at risk
EG003
Hypotension
Vascular disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0026 affected89 at risk
EG003
Fatigue
General disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0004 affected90 at risk
EG0010 affected90 at risk
EG0024 affected89 at risk
EG003
Oedema peripheral
General disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0004 affected90 at risk
EG0012 affected90 at risk
EG0023 affected89 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. Events for 2 patients in the placebo group in the Week 26 study report were reassessed as "chronic bronchitis" in the Week 52 study report.
EG0003 affected90 at risk
EG0014 affected90 at risk
EG0023 affected89 at risk
EG003
Influenza
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0003 affected90 at risk
EG0013 affected90 at risk
EG0022 affected89 at risk
EG003
Upper respiratory tract
Infections and infestations
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0001 affected90 at risk
EG0013 affected90 at risk
EG0021 affected89 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0003 affected90 at risk
EG0012 affected90 at risk
EG0021 affected89 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0004 affected90 at risk
EG0012 affected90 at risk
EG0022 affected89 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0002 affected90 at risk
EG0014 affected90 at risk
EG0022 affected89 at risk
EG003
Headache
Nervous system disorders
MEDDRA 14.1 / 15.0
Non-systematic Assessment
MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52
EG0003 affected90 at risk
EG0012 affected90 at risk
EG0022 affected89 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Point of Contact
Title
Organization
Phone
Extension
Email
Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
Janssen Research & Development, LLC
1-800-526-7736
ID
Term
D003924
Diabetes Mellitus, Type 2
D051437
Renal Insufficiency
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications