A 26-week Extension of the ZRHR-ERS-09-US Study Evaluatin... | NCT02649556

ID	Type	Description	Link
ZRHR-ERS-09-EXT-US	Other Identifier	Philip Morris Products S.A.

Description Module

Label	Type	Description	Intervention Names
THS 2.2	Experimental	Ad libitum use of THS 2.2	Other: THS 2.2
CC	Active Comparator	Ad libitum use of CC	Other: CC

Name	Type	Description	Arm Group Labels	Other Names
THS 2.2	Other	Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.	THS 2.2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levels of High Density Lipoprotein C (HDL-C).	Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.	52 weeks
Levels of White Blood Cells (WBC).	Total count in blood (GI/L). Mean values are provided as descriptive statistics.	52 weeks
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).	FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.	52 weeks
Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).	Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.	52 weeks
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).	Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.	52 weeks
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).	Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.	52 weeks
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).

Eligibility Module

Name	Affiliation	Role
Christelle Haziza, PhD	Philip Morris Products S.A.	Study Chair
Danielle Armas, MD	Celerion Arizona	Principal Investigator
Leonard Dunn, MD	Clinical Research West Florida	Principal Investigator
Hugh Coleman, MD	Covance	Principal Investigator
George Stoica, MD	Compass Research	Principal Investigator
Mark Adams, MD	Central Kentucky Research Associate	Principal Investigator
Peter Davidson, MD	Celerion Lincoln	Principal Investigator
John Rubino, MD	PMG Research of Raleigh	Principal Investigator
George Raad, MD	PMG Research of Charlotte	Principal Investigator
Kevin Cannon, MD	PMG Research of Wilmington

Facility	Status	City	State	ZIP	Country	Contacts
Celerion Arizona		Tempe	Arizona	85283	United States
Clinical Research West Florida

PubMed Identifier	Type	Citation	Retractions
38804903	Derived	Ansari SM, Hession PS, David M, Blanc N, de La Bourdonnaye G, Pouly S, Haziza C. Impact of switching from cigarette smoking to tobacco heating system use on biomarkers of potential harm in a randomized trial. Biomarkers. 2024 Jul;29(5):298-314. doi: 10.1080/1354750X.2024.2358318. Epub 2024 Jun 7.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	THS 2.2 Use	This reporting group comprised 230 subjects. The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
FG001

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	Aug 23, 2016	May 15, 2020

Arm/Group Information

ID	Title	Description
BG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
BG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
BG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)
BG003	Other Use	"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)
BG004	Total	Total of all reporting groups

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

Levels of High Density Lipoprotein C (HDL-C).

Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.

Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mg/dL

52 weeks

ID	Title	Description
OG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
OG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
OG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)
OG003	Other Use	"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)

Units	Counts
Participants	OG000168 OG001315 OG002103 OG003

Title

Denominators

Categories

Title	Measurements
	OG00052.2(49.5 to 54.8) OG00150.6(48.9 to 52.3) OG00254.0(49.7 to 58.4) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the "smokers' health profile". This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of HDL-C levels between CC and THS 2.2 and related 95% CI.					LS Mean Difference	1.75			2-Sided	95	-0.160	3.65					Other		Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.

Primary

Levels of White Blood Cells (WBC).

Total count in blood (GI/L). Mean values are provided as descriptive statistics.

Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

GI/L

52 weeks

ID	Title	Description
OG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
OG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
OG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)

Primary

Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).

FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.

Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Percent of predicted FEV1

52 weeks

ID	Title	Description
OG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
OG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
OG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)

Primary

Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).

Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.

Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

ng/mL

52 weeks

ID	Title	Description
OG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
OG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
OG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)

Primary

Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).

Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

pg/mg creat

52 weeks

ID	Title	Description
OG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
OG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
OG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)

Primary

Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).

Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

pg/mg creat

52 weeks

ID	Title	Description
OG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
OG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
OG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)

Primary

Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).

Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

pg/mg creat

52 weeks

ID	Title	Description
OG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
OG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
OG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)

Primary

Levels of Carboxyhemoglobin (COHb).

Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.

Full Analysis Set - As Exposed Analysis (FAS-EX). Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

percent change

52 weeks

ID	Title	Description
OG000	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)
OG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)
OG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.)

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	THS 2.2 Use	The "THS 2.2 use" product use category was defined as THS use of 70% or more over the entire analysis period. (≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on >50% of days in the analysis period.)	1	241	12	241	40	241
EG001	CC Use	The "CC use" product use category was defined as THS use of less than 1% over the entire analysis period. (≥1 THS 2.2 or CC use, and <1% THS 2.2 use over the entire analysis period and <1% THS 2.2 use on ≥ 50% of days in the analysis period.)	1	434	15	434	87	434
EG002	Dual Use	The "Dual use" product use category was defined as THS use of less than 70% over the entire analysis period. (≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 <70% over the analysis period, or THS 2.2-use and CC use categories do not apply to 50% of these days.) .	0	159	1	159	26	159
EG003	Other Use	"Other use" refers to any other product use over the entire analysis period. (Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns.)	1	106	1	106	13	106

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis with Peritonitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0002 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG0030 events0 affected106 at risk
Cellulitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Epiglottitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Influenza	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Tooth infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Urosepsis with Nephrolithiasis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0012 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Head injury with Seizure	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0002 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0010 events0 affected434 at risk EG0021 events1 affected159 at risk EG003
Rib fracture, Clavicle fracture, Pulmonary contusion, Pleural effusion, and Traumatic Hemothorax	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0015 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Alchohol abuse	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0012 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Metastases to small intestine with Anaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Vertebral osteophyte with Cervical Myelopathy	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0012 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Death	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Bereavement and Adjustment Disorder with Depressed Mood	Social circumstances	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0020 events0 affected159 at risk EG003
Foot Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected241 at risk EG0010 events0 affected434 at risk EG0020 events0 affected159 at risk EG003
Pyelonephritis Acute	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected241 at risk EG0011 events1 affected434 at risk EG0021 events1 affected159 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG00025 events21 affected241 at risk EG00145 events40 affected434 at risk EG00214 events11 affected159 at risk EG0039 events8 affected106 at risk
Hypertension	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG00013 events9 affected241 at risk EG00140 events26 affected434 at risk EG00211 events9 affected159 at risk EG003
Blood triglycerides increased	Investigations	MedDRA (18.0)	Non-systematic Assessment	EG00010 events10 affected241 at risk EG00128 events26 affected434 at risk EG0026 events6 affected159 at risk EG003