The Safety And Efficacy Of Maintenance Therapy With CP-69... | NCT01393899

ID	Type	Description	Link
2011-001754-28	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Intervention Names
Placebo BID	Placebo Comparator	Drug: Placebo
5mg BID	Experimental	Drug: CP-690,550
10mg BID	Experimental	Drug: CP-690,550

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	oral tablets twice daily	Placebo BID
CP-690,550

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26	Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.	Week 26

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20	Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Eligibility Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
ACMG Endoscopy Center		Anaheim	California	92801	United States
ACRI - Phase I, LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28209624	Derived	Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.

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	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
FG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
BG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
BG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
BG003	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, Customized

Number

Participants

Title

Denominators

Categories

Title	Measurements
	OG00038.10(27.94 to 49.16) OG00139.53(29.39 to 50.46) OG00255.81(44.92 to 66.28)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in Percentage	1.44			2-Sided	80	-12.11	14.99				No	Superiority or Other
OG000 OG002

Secondary

Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20

Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

mFAS

Posted

Number

80% Confidence Interval

Percentage of participants

Weeks 4, 8, 12 and 20

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Secondary

Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26

Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

mFAS

Posted

Number

80% Confidence Interval

Percentage of participants

Weeks 4, 8, 12, 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Secondary

Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26

Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

mFAS

Posted

Number

80% Confidence Interval

Percentage of participants

Weeks 4, 8, 12, 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Secondary

Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study

mFAS

Posted

Number

80% Confidence Interval

Percentage of participants

Weeks 4, 8, 12, 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Secondary

Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase

mFAS

Posted

Number

80% Confidence Interval

Percentage of participants

Weeks 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Secondary

Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase

Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

mFAS

Posted

Number

80% Confidence Interval

Percentage of participants

Weeks 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Secondary

CDAI Score by Week

CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity

mFAS

Posted

Mean

Standard Deviation

Score on a scale

Baseline and Weeks 4, 8, 12, 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Units

Secondary

Change From Baseline in CDAI Score by Week

mFAS

Posted

Mean

Standard Deviation

Score on a scale

Weeks 4, 8, 12, 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Units

Secondary

Kaplan-Meier Estimate of the Rate of Time to Relapse

Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

mFAS, n=number of participants remaining at risk

Posted

Number

80% Confidence Interval

Percent Probability

Weeks 4, 8 12, 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Secondary

Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline

Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

mFAS who were on steroids at A3921084 Baseline

Posted

Number

80% Confidence Interval

Percentage of participants

Week 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Secondary

C-Reactive Protein (CRP) by Week

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

mFAS

Posted

Mean

Standard Deviation

milligram per liter (mg/L)

Baseline and Weeks 4, 8, 12, 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in CRP by Week

mFAS

Posted

Mean

Standard Deviation

milligram per liter (mg/L)

Weeks 4, 8, 12, 20 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Units	Counts
Participants

Secondary

Fecal Calprotectin by Week

Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.

mFAS

Posted

Mean

Standard Deviation

milligrams per kilogram (mg/kg)

Baseline and Weeks 8, 12 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fecal Calprotectin by Week

mFAS

Posted

Mean

Standard Deviation

milligrams per kilogram (mg/kg)

Weeks 8, 12 and 26

ID	Title	Description
OG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
OG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Units	Counts
Participants

Secondary

Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose

Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.

Pharmacokinetic analysis set - included all participants who received at least 1 dose of study medication and had at least 1 measurable plasma concentration. n=number of observations above lower limit of quantification.

Posted

Mean

Standard Deviation

nanograms per milliliter (ng/mL)

Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit

ID	Title	Description
OG000	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
OG001	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.	7	59	28	59
EG001	Tofacitinib 5 mg BID	Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.	6	60	40	60
EG002	Tofacitinib 10 mg BID	Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.	8	61	35	61

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0010 affected60 at risk EG0020 affected61 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0003 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0010 affected60 at risk EG0020 affected61 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0021 affected61 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0021 affected61 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0020 affected61 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0020 affected61 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0021 affected61 at risk
Chest pain	General disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0021 affected61 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0010 affected60 at risk EG0020 affected61 at risk
Anal abscess	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0021 affected61 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0020 affected61 at risk
Clostridium difficile infection	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0020 affected61 at risk
Influenza	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0021 affected61 at risk
Rectal abscess	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0020 affected61 at risk
Septic shock	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0020 affected61 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0020 affected61 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0021 affected61 at risk
Abortion induced	Surgical and medical procedures	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0010 affected60 at risk EG0020 affected61 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0013 affected60 at risk EG0025 affected61 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0002 affected59 at risk EG0015 affected60 at risk EG0024 affected61 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0021 affected61 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG00010 affected59 at risk EG00111 affected60 at risk EG0027 affected61 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0013 affected60 at risk EG0025 affected61 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0003 affected59 at risk EG0012 affected60 at risk EG0021 affected61 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Nausea	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0011 affected60 at risk EG0022 affected61 at risk
Toothache	Gastrointestinal disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Asthenia	General disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Chest pain	General disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Fatigue	General disorders	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0012 affected60 at risk EG0021 affected61 at risk
Pyrexia	General disorders	MedDRA version 18.0	Non-systematic Assessment	EG0002 affected59 at risk EG0012 affected60 at risk EG0024 affected61 at risk
Bronchitis	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0013 affected60 at risk EG0020 affected61 at risk
Conjunctivitis	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0010 affected60 at risk EG0023 affected61 at risk
Folliculitis	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0023 affected61 at risk
Gastroenteritis	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0023 affected61 at risk
Herpes zoster	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Influenza	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0002 affected59 at risk EG0015 affected60 at risk EG0023 affected61 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0004 affected59 at risk EG00111 affected60 at risk EG0025 affected61 at risk
Oral herpes	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0002 affected59 at risk EG0011 affected60 at risk EG0020 affected61 at risk
Sinusitis	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0021 affected61 at risk
Tooth abscess	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0002 affected59 at risk EG0011 affected60 at risk EG0021 affected61 at risk
Urinary tract infection	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0004 affected59 at risk EG0016 affected60 at risk EG0028 affected61 at risk
Vaginal infection	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected32 at risk EG0010 affected30 at risk EG0021 affected24 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected32 at risk EG0010 affected30 at risk EG0021 affected24 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Blood creatinine increased	Investigations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Blood pressure increased	Investigations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Lymphocyte count decreased	Investigations	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0021 affected61 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0011 affected60 at risk EG0022 affected61 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 18.0	Non-systematic Assessment	EG0002 affected59 at risk EG0016 affected60 at risk EG0024 affected61 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0012 affected60 at risk EG0022 affected61 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Headache	Nervous system disorders	MedDRA version 18.0	Non-systematic Assessment	EG0002 affected59 at risk EG0014 affected60 at risk EG0022 affected61 at risk
Paraesthesia	Nervous system disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected32 at risk EG0010 affected30 at risk EG0021 affected24 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA version 18.0	Non-systematic Assessment	EG0001 affected59 at risk EG0012 affected60 at risk EG0020 affected61 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 18.0	Non-systematic Assessment	EG0002 affected59 at risk EG0010 affected60 at risk EG0020 affected61 at risk
Hypertension	Vascular disorders	MedDRA version 18.0	Non-systematic Assessment	EG0000 affected59 at risk EG0010 affected60 at risk EG0022 affected61 at risk

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