The CANTATA-M (CANagliflozin Treatment and Trial Analysis... | NCT01081834

NCT01081834

ID	Type	Description	Link
28431754DIA3005	Other Identifier	Janssen Research & Development, LLC

Status Module

Oversight Module

Description Module

Detailed Description

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). 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 canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 450 patients with inadequate glycemic control with diet and exercise will receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or 26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo group to improve glycemic control and remain in the study). Patients will participate in the study for approximately 60 to 68 weeks (referred to as the Main Study). The study will also include a High Glycemic Substudy in 50 to 100 patients with T2DM who have poorer glycemic control with diet and exercise. Patients in the substudy will be assigned to receive double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient participatation in the substudy will be approximately 34 to 42 weeks. During treatment, if a patient's fasting blood sugar remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single blind placebo for 1 or 2 weeks (wks) before randomization to the Main Study or the High Glycemic Substudy.

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
Canagliflozin 100 mg	Experimental	Each patient will receive 100 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).	Drug: Canagliflozin
Canagliflozin 300 mg	Experimental	Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).	Drug: Canagliflozin
Placebo/Sitagliptin	Experimental	In the Main Study, each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52.	Drug: Placebo Drug: Sitagliptin

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 (Main Study) or 26 weeks (High Glycemic Substudy)	Canagliflozin 100 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c From Baseline to Week 26 (Main Study)	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
Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)	The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.	Day 1 (Baseline) and Week 26

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients With HbA1c <7% at Week 26 (Main Study)	The table below shows the percentage of patients with HbA1c <7% at Week 26. 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 (Main Study)

Eligibility Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28327140	Derived	Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.
28241822	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Main Study: Placebo/Sitagliptin	In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
FG001	Main Study: Canagliflozin 100 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Main Study: Placebo/Sitagliptin	In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
BG001	Main Study: Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
BG002	Main Study: Canagliflozin 300 mg	In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
BG003	High Glycemic Substudy: Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
BG004	High Glycemic Substudy: Canagliflozin 300 mg	In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks.
BG005	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, 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
	BG00055.7± 10.88 BG00155.1± 10.83 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000104 BG001114 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

AUSTRIA

Title	Measurements
	BG0001 BG0012 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 (Main Study)

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	In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
OG001	Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
OG002	Canagliflozin 300 mg	In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.

Units	Counts
Participants	OG000189 OG001191 OG002194

Title

Denominators

Categories

Title	Measurements
	OG0000.14± 0.065 OG001-0.77± 0.065 OG002-1.03± 0.064

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		<0.001		Least-Squares Mean Difference	-0.91	Standard Error of the Mean	0.091	2-Sided	95	-1.088	-0.729					Superiority or Other
OG000 OG002		ANCOVA		<0.001

Primary

Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Posted

Least Squares Mean

Standard Error

Percent

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the High Glycemic Substudy, no patients received placebo.
OG001	Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
OG002	Canagliflozin 300 mg	In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.

Secondary

Percentage of Patients With HbA1c <7% at Week 26 (Main Study)

The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.

Posted

Number

Percentage of patients

Week 26

ID	Title	Description
OG000	Placebo	In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
OG001	Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
OG002	Canagliflozin 300 mg	In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.

Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)

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.

Posted

Least Squares Mean

Standard Error

mg/dL

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
OG001	Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
OG002	Canagliflozin 300 mg	In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.

Secondary

Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose 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.

Posted

Least Squares Mean

Standard Error

mg/dL

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
OG001	Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
OG002	Canagliflozin 300 mg	In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.

Secondary

Percent Change in Body Weight From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean percent change in body weight 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 percent change.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
OG001	Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
OG002	Canagliflozin 300 mg	In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.

Secondary

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean change in SBP 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.

Posted

Least Squares Mean

Standard Error

mmHg

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
OG001	Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
OG002	Canagliflozin 300 mg	In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.

Secondary

Percent Change in Triglycerides From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean percent change in triglycerides 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 percent change.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the Main study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
OG001	Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
OG002	Canagliflozin 300 mg	In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.

Secondary

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean percent change in HDL-C 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 percent change.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
OG001	Canagliflozin 100 mg	In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
OG002	Canagliflozin 300 mg	In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.

Secondary

Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)

The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Posted

Number

Percentage of patients

Week 26

ID	Title	Description
OG000	Placebo	In the High Glycemic Substudy, no patients received placebo.
OG001	Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
OG002	Canagliflozin 300 mg	In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.

Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Posted

Least Squares Mean

Standard Error

mg/dL

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the High Glycemic Substudy, no patients received placebo.
OG001	Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
OG002	Canagliflozin 300 mg	In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.

Secondary

Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Posted

Least Squares Mean

Standard Error

mg/dL

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the High Glycemic Substudy, no patients received placebo.
OG001	Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
OG002	Canagliflozin 300 mg	In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.

Secondary

Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the High Glycemic Substudy, no patients received placebo.
OG001	Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
OG002	Canagliflozin 300 mg	In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.

Secondary

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Posted

Least Squares Mean

Standard Error

mmHg

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the High Glycemic Substudy, no patients received placebo.
OG001	Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
OG002	Canagliflozin 300 mg	In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.

Secondary

Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the High Glycemic Substudy, no patients received placebo.
OG001	Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
OG002	Canagliflozin 300 mg	In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.

Secondary

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo	In the High Glycemic Substudy, no patients received placebo.
OG001	Canagliflozin 100 mg	In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
OG002	Canagliflozin 300 mg	In the High Glycemic substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Main Study (Baseline to Week 26): Placebo	Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26.	4	192	38	192
EG001	Main Study (Baseline to Week 26): Cana 100 mg	Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.	8	195	39	195
EG002	Main Study (Baseline to Week 26): Cana 300 mg	Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.	2	197	51	197
EG003	Main Study (Baseline to Week 52): Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52.	11	192	63	192
EG004	Main Study (Baseline to Week 52): Cana 100 mg	Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.	11	195	54	195
EG005	Main Study (Baseline to Week 52): Cana 300 mg	Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.	5	197	69	197
EG006	High Glycemic Substudy (Baseline to Week 26): Cana 100 mg	Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.	0	47	6	47
EG007	High Glycemic Substudy (Baseline to Week 26): Cana 300 mg	Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.	1	44	6	44

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG0030 affected192 at risk EG0041 affected195 at risk EG0050 affected197 at risk EG0060 affected47 at risk EG0070 affected44 at risk
Abdominal pain	Gastrointestinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0001 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Nausea	Gastrointestinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Vomiting	Gastrointestinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Ischaemic hepatitis	Hepatobiliary disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Abscess limb	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0001 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Bacterial prostatitis	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Cellulitis	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0001 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Diverticulitis	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Pneumonia	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Septic shock	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MEDDRA 14.0	Non-systematic Assessment	EG0001 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Brain herniation	Injury, poisoning and procedural complications	MEDDRA 14.0	Non-systematic Assessment	EG0001 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Wound	Injury, poisoning and procedural complications	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0021 affected197 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MEDDRA 14.0	Non-systematic Assessment	EG0001 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Renal colic	Renal and urinary disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0021 affected197 at risk EG003
Renal failure acute	Renal and urinary disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0012 affected195 at risk EG0020 affected197 at risk EG003
Deep vein thrombosis	Vascular disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0021 affected197 at risk EG003
Thrombosis	Vascular disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0011 affected195 at risk EG0020 affected197 at risk EG003
Myocardial infarction	Cardiac disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Pericardial effusion	Cardiac disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Liver disorder	Hepatobiliary disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Appendicitis	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Gastrointestinal infection	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Viral pericarditis	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Skeletal injury	Injury, poisoning and procedural complications	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Hepatic enzyme increased	Investigations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG00010 affected192 at risk EG00110 affected195 at risk EG00216 affected197 at risk EG00315 affected192 at risk EG00414 affected195 at risk EG00520 affected197 at risk EG0062 affected47 at risk EG0073 affected44 at risk
Upper respiratory tract infection	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG00011 affected192 at risk EG0017 affected195 at risk EG0029 affected197 at risk EG003
Urinary tract infection	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0008 affected192 at risk EG00114 affected195 at risk EG0029 affected197 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MEDDRA 14.0	Non-systematic Assessment	EG0006 affected192 at risk EG0015 affected195 at risk EG00212 affected197 at risk EG003
Headache	Nervous system disorders	MEDDRA 14.0	Non-systematic Assessment	EG0007 affected192 at risk EG00114 affected195 at risk EG00212 affected197 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Influenza	Infections and infestations	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MEDDRA 14.0	Non-systematic Assessment	EG0000 affected192 at risk EG0010 affected195 at risk EG0020 affected197 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

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

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D014230	Triazoles
D001393	Azoles
D011719	Pyrazines