An Open-label, Long-term Safety Study of Linaclotide in P... | NCT00730171

Status Module

Name	Class
Forest Laboratories	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Linaclotide	Experimental	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.	Drug: Linaclotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linaclotide	Drug	Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.	Linaclotide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug.	From first dose of open-label study drug up to 78 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jeffrey M. Johnston, MD, FACP	Ironwood Pharmaceuticals, Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Ironwood Investigational Site		Birmingham	Alabama	35209	United States
Ironwood Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Overal Safey Population: Total	All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Overall Safety Population	All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00065 OG001389 OG002454

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	CC Safety Population: Total	RI and RO participants who met the modified Rome II criteria for CC and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.	2	607	41	607	283	607
EG001	IBS-C Safety Population: Total	RI and RO participants who met the modified Rome II criteria for IBS-C and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.	2	1,119	56	1,119	572	1,119
EG002	Overall Safety Population: Total	All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.	4	1,725	97	1,725	855	1,725

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected607 at risk EG0013 affected1,119 at risk EG0026 affected1,725 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected607 at risk EG0011 affected1,119 at risk EG0023 affected1,725 at risk
Bradycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected607 at risk EG0010 affected1,119 at risk EG0022 affected1,725 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected607 at risk EG0010 affected1,119 at risk EG0022 affected1,725 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected607 at risk EG0010 affected1,119 at risk EG0022 affected1,725 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected607 at risk EG0010 affected1,119 at risk EG0022 affected1,725 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected607 at risk EG0010 affected1,119 at risk EG0022 affected1,725 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0011 affected1,119 at risk EG0022 affected1,725 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0013 affected1,119 at risk EG0024 affected1,725 at risk
Chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0011 affected1,119 at risk EG0022 affected1,725 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0011 affected1,119 at risk EG0022 affected1,725 at risk
Convulsion	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0012 affected1,119 at risk EG0023 affected1,725 at risk
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0012 affected1,119 at risk EG0023 affected1,725 at risk
Diverticulitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0011 affected1,119 at risk EG0022 affected1,725 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0011 affected1,119 at risk EG0022 affected1,725 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0012 affected1,119 at risk EG0023 affected1,725 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0011 affected1,119 at risk EG0022 affected1,725 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Malocclusion	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Micrognathia	Congenital, familial and genetic disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Oesophageal squamous cell carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0012 affected1,119 at risk EG0023 affected1,725 at risk
Pneumothorax traumatic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Prognathism	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Sepsis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Suicide attempt	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Syncope	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Thyrotoxic crisis	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0010 affected1,119 at risk EG0021 affected1,725 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected607 at risk EG0011 affected1,119 at risk EG0022 affected1,725 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0013 affected1,119 at risk EG0023 affected1,725 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0012 affected1,119 at risk EG0022 affected1,725 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0012 affected1,119 at risk EG0022 affected1,725 at risk
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0012 affected1,119 at risk EG0022 affected1,725 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0012 affected1,119 at risk EG0022 affected1,725 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0012 affected1,119 at risk EG0022 affected1,725 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Anorexia nervosa	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Clostridial infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Hypothermia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Ileus	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Intertrigo candida	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Lipodystrophy acquired	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Meningitis viral	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Oedema peripheral	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected607 at risk EG0011 affected1,119 at risk EG0021 affected1,725 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG000179 affected607 at risk EG001358 affected1,119 at risk EG002537 affected1,725 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00023 affected607 at risk EG00174 affected1,119 at risk EG00297 affected1,725 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00036 affected607 at risk EG00159 affected1,119 at risk EG00295 affected1,725 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00016 affected607 at risk EG00165 affected1,119 at risk EG00281 affected1,725 at risk
Flatulence	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00034 affected607 at risk EG00136 affected1,119 at risk EG00270 affected1,725 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00044 affected607 at risk EG00185 affected1,119 at risk EG002129 affected1,725 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00040 affected607 at risk EG00183 affected1,119 at risk EG002123 affected1,725 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00027 affected607 at risk EG00161 affected1,119 at risk EG00288 affected1,725 at risk