Long-Term Safety Of PF-00547659 In Ulcerative Colitis | NCT01771809

ID	Type	Description	Link
2012-002031-28	EudraCT Number
TURANDOT II	Other Identifier	Alias Study Number

Status Module

Oversight 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
SHP647 75 mg	Experimental	Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.	Drug: 75mg SHP647 (PF-00547659)
SHP647 225 mg	Experimental	Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.	Drug: 225mg SHP647 (PF-00547659)

Name	Type	Description	Arm Group Labels	Other Names
75mg SHP647 (PF-00547659)	Drug	75 mg sterile liquid injected subcutaneously every 4 weeks.	SHP647 75 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)	An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.	From start of study drug administration up to 168 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Mucosal Healing at Week 16	Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment [PGA]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.

Eligibility Module

Name	Affiliation	Role
Shire Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona - Scottsdale		Scottsdale	Arizona	85259	United States
UCSD Altman Clinical and Translational Research Institute

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SHP647 75 mg	Participants received 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.

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	Nov 14, 2016	Dec 11, 2018

Arm/Group Information

ID	Title	Description
BG000	SHP647 75 mg	Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
BG001	SHP647 225 mg	Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
BG002	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, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00040.5± 12.75 BG00141.1± 13.68 BG00240.8± 13.21

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00062 BG00170 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0016 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.

SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.

Posted

Count of Participants

Participants

From start of study drug administration up to 168 weeks

ID	Title	Description
OG000	SHP647 75 mg	Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
OG001	SHP647 225 mg	Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.

Units	Counts
Participants	OG000164 OG001166

Title

Denominators

Categories

Participants with any TEAE

Title	Measurements
	OG000146 OG001147

Participants with any TESAE

Title	Measurements
	OG000

Secondary

Percentage of Participants With Mucosal Healing at Week 16

Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment [PGA]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.

SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.

Posted

Number

Percentage of participants

Week 16

ID	Title	Description
OG000	SHP647 75 mg	Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
OG001

Secondary

Serum Trough Concentrations of SHP647 Versus Time

Serum trough concentrations of SHP647 versus time was reported.

The pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of SHP647 and for whom at least 1 postdose PK sample was collected. Here 'Number of Participants Analyzed' refers to the number of participants evaluable for specific timepoint.

Posted

Mean

Standard Deviation

Micrograms/liter (ug/L)

Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156

ID	Title	Description
OG000	SHP647 75 mg	Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
OG001	SHP647 225 mg	Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.

Secondary

Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)

The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64. The number of participants with positive ADA was reported.

The SAS consisted of all enrolled participants who had received at least 1 dose of SHP647. Here, "number of participants analyzed" refers to the number of participants evaluable for this outcome at specific time points.

Posted

Count of Participants

Participants

Baseline, Week 8, 16, 24, 40, 48, 64 and 156

ID	Title	Description
OG000	SHP647 75 mg	Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
OG001	SHP647 225 mg	Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.

Secondary

Number of Participants With Positive Neutralizing Antibodies (NAb)

The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64.

Here, "number of participants analyzed" refers to the number of participants evaluable for this outcome at specific time points with non-missing ADA sample.

Posted

Count of Participants

Participants

Baseline, Week 8, 16, 24, 40, 48, 64 and 156

ID	Title	Description
OG000	SHP647 75 mg	Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
OG001	SHP647 225 mg

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	SHP647 75 mg	Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.	1	164	34	164	116	164
EG001	SHP647 225 mg	Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.	0	166	40	166	119	166

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 events2 affected164 at risk EG0013 events1 affected166 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Serous cystadenocarcinoma ovary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Retinal detachment	Eye disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00019 events15 affected164 at risk EG00119 events18 affected166 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Enteritis	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Large intestinal stenosis	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected166 at risk
Non-Cardiac chest pain	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Pyrexia	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Arrhythmogenic right ventricular dysplasia	Congenital, familial and genetic disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Arrhythmia	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Serum sickness	Immune system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Anal abscess	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Appendicitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Cellulitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Chronic sinusitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0002 events2 affected164 at risk EG0011 events1 affected166 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Meningitis listeria	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Meningitis viral	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Pelvic abscess	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected166 at risk
Pharyngitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Pneumonia	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected166 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Viral infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Anastomotic fistula	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Stoma complication	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Blood iron decreased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Renal colic	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0012 events2 affected166 at risk
Basilar migraine	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Epilepsy	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Headache	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0012 events2 affected166 at risk
Syncope	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Typical aura without headache	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Depression	Psychiatric disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Suicide attempt	Psychiatric disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected166 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected166 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG00041 events27 affected164 at risk EG00142 events29 affected166 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG00015 events12 affected164 at risk EG00120 events18 affected166 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00014 events9 affected164 at risk EG00133 events20 affected166 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00052 events41 affected164 at risk EG00150 events36 affected166 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00013 events11 affected164 at risk EG00111 events7 affected166 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00010 events8 affected164 at risk EG00120 events19 affected166 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00010 events10 affected164 at risk EG0017 events7 affected166 at risk
Influenza like illness	General disorders	MedDRA 19.1	Non-systematic Assessment	EG00011 events8 affected164 at risk EG00110 events9 affected166 at risk
Pyrexia	General disorders	MedDRA 19.1	Non-systematic Assessment	EG00020 events14 affected164 at risk EG00110 events7 affected166 at risk
Bronchitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG00012 events10 affected164 at risk EG00112 events8 affected166 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG00012 events11 affected164 at risk EG0014 events4 affected166 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG00025 events18 affected164 at risk EG00117 events13 affected166 at risk
Influenza	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0009 events8 affected164 at risk EG00119 events15 affected166 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG00027 events20 affected164 at risk EG00144 events28 affected166 at risk
Pharyngitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0002 events2 affected164 at risk EG00120 events17 affected166 at risk
Sinusitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG00011 events7 affected164 at risk EG00114 events10 affected166 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG00034 events23 affected164 at risk EG00135 events20 affected166 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG00015 events11 affected164 at risk EG00112 events10 affected166 at risk
Headache	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG00023 events17 affected164 at risk EG00156 events21 affected166 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00020 events20 affected164 at risk EG00112 events11 affected166 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0009 events8 affected164 at risk EG00113 events13 affected166 at risk

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases