Study To Test Whether PF-00547659 Is Safe And Improves Di... | NCT01276509

NCT01276509

ID	Type	Description	Link
2010-023437-30	EudraCT Number
OPERA	Other Identifier	Alias Study Number

Status Module

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
Placebo-SC Injection	Placebo Comparator	Placebo delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection
Drug Dose level 1- SC injection	Experimental	Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection
Drug Dose level 2-SC injection	Experimental	Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection
Drug Dose level 3- SC injection	Experimental	Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection

Name	Type	Description	Arm Group Labels	Other Names
PF-00547659 SC injection	Drug	Placebo delivered SC, 3 doses separated by 4 weeks	Placebo-SC Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate	Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.	Week 8 and week 12

Secondary Outcomes

Measure	Description	Time Frame
Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo	Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.	Week 0-12
Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clopton Clinic		Jonesboro	Arkansas	72401	United States
Gastroenterology Specialists of Arkansas

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32013314	Derived	Saruta M, Park DI, Kim YH, Yang SK, Jang BI, Cheon JH, Im JP, Kanai T, Katsuno T, Ishiguro Y, Nagaoka M, Isogawa N, Li Y, Banerjee A, Ahmad A, Hassan-Zahraee M, Clare R, Gorelick KJ, Cataldi F, Watanabe M, Hibi T. Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn's disease in Japanese and Korean patients: the OPERA study. Intest Res. 2020 Jan;18(1):45-55. doi: 10.5217/ir.2019.00039. Epub 2020 Jan 30.
28982740

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
FG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks

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

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
BG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
BG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
BG003	Placebo	Placebo delivered SC, 3 doses separated by 4 weeks.
BG004	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

Week 8 (n =50, 55, 62, 56)

Title	Measurements
	OG00052.7 OG00160.1 OG00262.7 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 OG003	Difference from placebo at Week 8	Mixed Models Analysis		0.3393		Difference in Percentage	0.050	Standard Error of the Mean	0.121	2-Sided	90	-0.149	0.249					Superiority or Other (legacy)
OG001 OG003	Difference from placebo at Week 8

Secondary

Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo

Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.

The safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Number

Number of participants

Week 0-12

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
OG003	Placebo	Placebo delivered SC, 3 doses separated by 4 weeks.

Secondary

Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo

Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.

The safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Number

events

Week 0-12

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
OG003	Placebo	Placebo delivered SC, 3 doses separated by 4 weeks.

Secondary

Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission

Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Number

Percentage of Participants

Weeks 8 and week 12

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
OG003	Placebo	Placebo delivered SC, 3 doses separated by 4 weeks.

Secondary

Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time

Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Number

90% Confidence Interval

Percentage of Participants

Week 2, 4, 6, 8, 10 and 12

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
OG003	Placebo	Placebo delivered SC, 3 doses separated by 4 weeks.

Secondary

Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer

Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Number

90% Confidence Interval

Percentage of Participants

Week 2, 4, 6, 8, 10 and 12

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
OG003	Placebo	Placebo delivered SC, 3 doses separated by 4 weeks.

Secondary

Immunogenicity Assessment of Anti-drug Antibodies (ADAs)

Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659

The safety analysis set included all participants who receive at least 1 dose of PF-00547659. Participants in placebo arm were not included in this analysis.

Posted

Number

events

Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks

Units	Counts
Participants

Secondary

The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)

The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg•hr/mL

Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks

Secondary

The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)

The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg•hr/mL

Day 1, 14, and 28

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks

Secondary

The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/mL

Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks

Secondary

The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Posted

Median

Full Range

Hours

Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks

Units	Counts

Secondary

The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Posted

Mean

Standard Deviation

Day

Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks

Units	Counts

Secondary

The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/hr

Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

ID	Title	Description
OG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
OG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
OG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PF-00547659 22.5 mg	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	12	66	36	66
EG001	PF-00547659 75 mg	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	11	65	32	65
EG002	PF-00547659 225 mg	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	11	68	42	68
EG003	Placebo	Placebo delivered SC, 3 doses separated by 4 weeks.	6	63	35	63

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal adhesions	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0021 affected68 at risk EG0030 affected63 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0021 affected68 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected66 at risk EG0016 affected65 at risk EG0024 affected68 at risk EG003
Fistula of small intestine	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Rectal stenosis	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0022 affected68 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Chest pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Pyrexia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0021 affected68 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Anal abscess	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0021 affected68 at risk EG003
Appendicitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Liver abscess	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0021 affected68 at risk EG003
Rectal abscess	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0021 affected68 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Cerebellar infarction	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0020 affected68 at risk EG003
Headache	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0021 affected68 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0021 affected68 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0021 affected68 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected65 at risk EG0021 affected68 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0007 affected66 at risk EG0011 affected65 at risk EG0024 affected68 at risk EG0033 affected63 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected66 at risk EG0017 affected65 at risk EG0021 affected68 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0014 affected65 at risk EG0021 affected68 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0007 affected66 at risk EG0014 affected65 at risk EG0025 affected68 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0014 affected65 at risk EG0021 affected68 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected66 at risk EG0013 affected65 at risk EG0023 affected68 at risk EG003
Fatigue	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected66 at risk EG0014 affected65 at risk EG0022 affected68 at risk EG003
Injection site erythema	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected66 at risk EG0014 affected65 at risk EG0022 affected68 at risk EG003
Oedema peripheral	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0025 affected68 at risk EG003
Pyrexia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected66 at risk EG0016 affected65 at risk EG0028 affected68 at risk EG003
Influenza	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0004 affected66 at risk EG0012 affected65 at risk EG0021 affected68 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0003 affected66 at risk EG0014 affected65 at risk EG0025 affected68 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected65 at risk EG0023 affected68 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0003 affected66 at risk EG0010 affected65 at risk EG0020 affected68 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected66 at risk EG0016 affected65 at risk EG0025 affected68 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected65 at risk EG0024 affected68 at risk EG003
Headache	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0006 affected66 at risk EG0013 affected65 at risk EG0028 affected68 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected66 at risk EG0012 affected65 at risk EG0024 affected68 at risk EG003

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases