An Open-Label, Long-Term Safety Study of Linaclotide in P... | NCT00765999

Status Module

Name	Class
Ironwood Pharmaceuticals, Inc.	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 in participants with either CC or IBS-C. 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.	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 Events (TEAEs)	An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).	Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.

Eligibility Module

Name	Affiliation	Role
Paul Eng, PhD	Forest Laboratories	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Innovative Clinical Trials		Birmingham	Alabama	35205	United States
Parkway Medical Center

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Linaclotide	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced adverse events (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

Arm/Group Information

ID	Title	Description
BG000	Linaclotide	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced adverse events (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
	BG00046.0± 13.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001414
Male	BG000140

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG0001197
African American	BG000312

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic	BG000192
Non-Hispanic	BG0001362

Weight

Mean

Standard Deviation

kilogram (kg)

Title

Denominators

Categories

Title	Measurements
	BG00076.02± 17.85

Height

Mean

Standard Deviation

centimeters (cm)

Title

Denominators

Categories

Title	Measurements
	BG000164.59± 8.05

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00028.03± 6.14

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

Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)

An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).

The analysis population consisted of participants in the Enrolled Population who received at least 1 dose of the open-label investigational product. It was identified that 1 participant enrolled twice in the study under 2 ID numbers; this participant is included in both the IBS-C and CC Safety Populations, leading to an analyzed population of 1555.

Posted

Count of Participants

Participants

Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.

ID	Title	Description
OG000	Linaclotide (CC)	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with CC. 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, paticipants 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.
OG001	Linaclotide (IBS-C)	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with IBS-C. 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.

Units	Counts
Participants	OG000523 OG0011032

Title

Denominators

Categories

Title	Measurements
	OG000399 OG001748

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	Linaclotide (CC)	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with CC. 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.			31	523	267	523
EG001	Linaclotide (IBS-C)	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with IBS-C. 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.			57	1,032	510	1,032

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected523 at risk EG0011 affected1,032 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected523 at risk EG0010 affected1,032 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected523 at risk EG0010 affected1,032 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected523 at risk EG0012 affected1,032 at risk
Goitre	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected523 at risk EG0011 affected1,032 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected523 at risk EG0010 affected1,032 at risk
Syncope	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected523 at risk EG0012 affected1,032 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected523 at risk EG0010 affected1,032 at risk
Abdominal abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0011 affected1,032 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0011 affected1,032 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0013 affected1,032 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0011 affected1,032 at risk
Bunion	Surgical and medical procedures	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Chest discomfort	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Diverticulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0011 affected1,032 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0011 affected1,032 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0014 affected1,032 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected523 at risk EG0012 affected1,032 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Post procedural infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0011 affected1,032 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Spigelian hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0010 affected1,032 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected523 at risk EG0011 affected1,032 at risk
Suicide attempt	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Transient ischaemic attack	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Pelvic adhesions	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Sepsis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0000 affected523 at risk EG0013 affected1,032 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0012 affected1,032 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0012 affected1,032 at risk
Ileus	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0012 affected1,032 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0012 affected1,032 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0012 affected1,032 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 13.0	Non-systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Adhesion	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Appendicitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Cataract	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Cholecystitis infective	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected523 at risk EG0011 affected1,032 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG000179 affected523 at risk EG001345 affected1,032 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00034 affected523 at risk EG00169 affected1,032 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00029 affected523 at risk EG00151 affected1,032 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00028 affected523 at risk EG00135 affected1,032 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00031 affected523 at risk EG00165 affected1,032 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00032 affected523 at risk EG00161 affected1,032 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00030 affected523 at risk EG00158 affected1,032 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00034 affected523 at risk EG00142 affected1,032 at risk

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms