Evaluation of Efficacy and Safety of Brazikumab (MEDI2070... | NCT02574637

ID	Type	Description	Link
2015-000609-38	EudraCT 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	Placebo Comparator	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.	Drug: Brazikumab IV Infusion Drug: Brazikumab SC Injection Drug: Placebo
Brazikumab High Dose	Experimental	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.	Drug: Brazikumab IV Infusion Drug: Brazikumab SC Injection Drug: Placebo
Brazikumab High-Medium Dose	Experimental	Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.	Drug: Brazikumab IV Infusion Drug: Brazikumab SC Injection Drug: Placebo
Brazikumab Low-Medium Dose	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brazikumab IV Infusion	Drug	Brazikumab IV infusion as per protocol specified dosing schedule.	Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8	CDAI remission was defined as a CDAI score of <150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.	Week 8

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Loose/Liquid Stool Frequency Response	Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Arthritis & Rheumatology Research, PLLC		Phoenix	Arizona	85037	United States
Research Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Double Blind (DB): Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.
FG001	DB: Brazikumab High Dose

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_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 27, 2018

Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
BG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
BG002	Brazikumab High-Medium Dose	Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
BG003	Brazikumab Low-Medium Dose	Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
BG004	Brazikumab Low Dose	Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
BG005	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
	BG00035.3± 10.34 BG00137.2± 13.29 BG00238.3± 15.03 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

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

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8

CDAI remission was defined as a CDAI score of <150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period.

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG002	Brazikumab High-Medium Dose	Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG003	Brazikumab Low-Medium Dose	Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
OG004	Brazikumab Low Dose	Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.

Units	Counts
Participants	OG0004 OG0015 OG0029 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.0 OG0010.0 OG00222.2 OG003

Secondary

Percentage of Participants With Loose/Liquid Stool Frequency Response

Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.

Posted

Number

percentage of participants

Baseline, Weeks 8, 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Secondary

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

CDAI response was defined as a decrease from baseline in the CDAI score of ≥100. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Posted

Number

percentage of participants

Baseline, Weeks 8, 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose

Secondary

Percentage of Participants With CDAI Clinical Remission

CDAI clinical remission was defined as a CDAI score of <150. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Posted

Number

percentage of participants

Weeks 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Secondary

Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response

SES-CD response was defined as a decrease from baseline in SES-CD score of ≥ 50%. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.

Posted

Number

percentage of participants

Baseline, Weeks 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose

Secondary

Percentage of Participants With Loose/Liquid Stool Frequency Remission

Posted

Number

percentage of participants

Baseline, Weeks 8, 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Secondary

Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Remission

SES-CD remission was defined as a Total SES-CD score of ≤4 and no subscore >2. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.

Posted

Number

percentage of participants

Weeks 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose

Secondary

Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission

PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain (on an 11-point scale where 0=no pain to 10=worst imaginable pain). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2-remission was defined as PRO2 less than 8 points. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.

Posted

Number

percentage of participants

Weeks 8, 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Secondary

Percentage of Participants With PRO2 Response

PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. PRO2 response was defined as remission or response in one symptom (either abdominal pain or stool frequency) plus response in the other: a) abdominal pain remission: On an 11-point (0 to 10) pain scale: During 1 week, no daily score > 2, b) abdominal pain response: On an 11-point (0 to 10) pain scale: ≥ 30% reduction in weekly pain score from baseline, c) loose/liquid stool frequency remission: Counting stools identified as Type 6 or 7 on Bristol Stool Form Scale (BSFS), (The BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool), during 1 week, each daily loose/liquid stool count ≤ 3, d) loose/liquid stool frequency response: Counting stools identified as Type 6 or 7 on BSFS, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline.

Posted

Number

percentage of participants

Baseline, Weeks 8, 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.

Secondary

Serum Interleukin (IL)-22 and Serum Lipocalin 2 (LCN2) Concentration as a Biomarker of Brazikumab's Efficacy

Data for predictive biomarker analysis was not collected due to small number of participants available for analysis.

Posted

Weeks 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG002	Brazikumab High-Medium Dose	Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Secondary

Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28

CDAI modified sustained clinical remission was defined as a CDAI score of <150 at both Weeks 8 and 28. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=mild to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Data was not collected for this endpoint.

Posted

Weeks 8 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Secondary

Serum Brazikumab Concentration

The Pharmacokinetic (PK) population included all participants who received at least 1 dose of investigational product and had at least 1 PK sample containing quantifiable brazikumab. Number analyzed is number of participants with evaluable data at given time-point.

Posted

Mean

Standard Deviation

nanograms per milliliters (ng/mL)

Predose at Weeks 0, 1, 4, 8, 12, 16, 28; Postdose at Weeks 0 and 4

ID	Title	Description
OG000	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG001	Brazikumab High-Medium Dose	Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG002	Brazikumab Low-Medium Dose	Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.

Secondary

Number of Participants With Serum Anti-drug Antibodies for Brazikumab

Posted

Count of Participants

Participants

Predose at Weeks 0, 4, 12, 16, 28, 40 and 52

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG002	Brazikumab High-Medium Dose	Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest and TEAEs Leading to Discontinuation

An AE is any untoward medical occurrence in a patient/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not related to the investigational product. A TEAE is any new AE or worsening of an existing condition after initiation of treatment. An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life threatening, a congenital anomaly/birth defect, or an important medical event. AE of special interest were infusion/injection-site reactions, hypersensitivity reactions, malignancies, cardiac events like myocardial infarction, stroke/cardiovascular death, ocular AE including cataracts.

Safety population included all participants who received at least 1 dose of investigational product.

Posted

Count of Participants

Participants

From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.

Secondary

Number of Participants With Clinically Significant Laboratory Values

Laboratory parameters included tests for hematology, serum chemistry and urinalysis. Laboratory values that were outside the reference range, considered clinically significant were reported.

Safety population included all participants who received at least 1 dose of investigational product.

Posted

Count of Participants

Participants

From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG002	Brazikumab High-Medium Dose

Secondary

Percentage of Participants With Abdominal Pain Response

Abdominal pain response is defined as a ≥ 30% reduction in weekly pain score from baseline on an 11-point (0 to 10) pain scale, where 0 = no pain and 10 = worst imaginable pain.

Posted

Number

percentage of participants

Baseline; Weeks 8, 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG002

Secondary

Percentage of Participants With Abdominal Pain Remission

Abdominal pain remission is defined as no daily score > 2 on an 11-point (0 to 10) pain scale during 1 week, where 0 = no pain and 10 = worst imaginable pain.

Posted

Number

percentage of participants

Weeks 8, 16 and 28

ID	Title	Description
OG000	Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
OG001	Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
OG002

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DB: Placebo	Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase.	5	0	5	5	5
EG001	DB: Brazikumab High Dose	Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks at Weeks 8 and 12 in the induction phase and Weeks 16, 20 and 24 in the maintenance phase.	5	1	5	4	5
EG002	DB: Brazikumab High-Medium Dose	Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.	9	0	9	8	9
EG003	DB: Brazikumab Low-Medium Dose	Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.	7	1	7	7	7
EG004	DB: Brazikumab Low Dose	Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase.	3	1	3	1	3
EG005	OL: Placebo/Brazikumab 210 mg	Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received placebo-matching brazikumab in the double-blind treatment period.	2	0	2	2	2
EG006	OL: Brazikumab High Dose/Brazikumab 210 mg	Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high dose of brazikumab in the double-blind treatment period.	3	0	3	1	3
EG007	OL: Brazikumab High-Medium Dose/Brazikumab 210 mg	Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high-medium dose of brazikumab in the double-blind treatment period.	2	0	2	1	2
EG008	OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg	Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low-medium dose of brazikumab in the double-blind treatment period.	3	1	3	1	3
EG009	OL: Brazikumab Low Dose/Brazikumab 210 mg	Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low dose of brazikumab in the double-blind treatment period.	1	0	1	0	1

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Crohn's disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG0031 affected7 at risk EG0041 affected3 at risk EG0050 affected2 at risk EG0060 affected3 at risk EG0070 affected2 at risk EG0080 affected3 at risk EG0090 affected1 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG0030 affected7 at risk EG0040 affected3 at risk EG0050 affected2 at risk EG0060 affected3 at risk EG0070 affected2 at risk EG0080 affected3 at risk EG0090 affected1 at risk
Palpitations	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Cataract	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Vision blurred	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Iritis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Defaecation urgency	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Asthenia	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Feeling hot	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Peripheral swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Folliculitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0012 affected5 at risk EG0020 affected9 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Viral infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Skin candida	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Postoperative abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Vitamin D decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
White blood cell count increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Eye naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0021 affected9 at risk EG003
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected9 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected9 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Phlebitis superficial	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Drug intolerance	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Enterobiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Stress	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected9 at risk EG003

Certain Agreements

ID	Term
D003424	Crohn Disease
D015212	Inflammatory Bowel Diseases

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