An Investigational Study of Experimental Medication BMS-9... | NCT03599622

ID	Type	Description	Link
2017-001976-48	EudraCT Number

Label	Type	Intervention Names
BMS-986165 Dose 1	Experimental	Drug: BMS-986165
BMS-986165 Dose 2	Experimental	Drug: BMS-986165
Placebo	Placebo Comparator	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BMS-986165	Drug	Specified dose on specified days	BMS-986165 Dose 1 BMS-986165 Dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Participants Achieving Clinical Remission at Week 12	Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.	12 weeks after first dose
Percent of Participants Achieving Endoscopic Response at Week 12	Endoscopic Response is defined as >= 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.	12 weeks after first dose

Secondary Outcomes

Measure	Description	Time Frame
Percent of Participants Achieving Clinical Response at Week 12	Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of ≥ 100 points or a total CDAI score < 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Baseline refers to the initial set of before data collected from participants before starting study treatment. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0258		Los Angeles	California	90067-2015	United States
Local Institution - 0247

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Placebo	Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.

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	Sep 2, 2022

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.
BG001	3 mg BMS-986165	BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.
BG002	6 mg BMS-986165	BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.
BG003	12 mg BMS-986165	BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.
BG004	Total	Total of all reporting groups

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

Percent of Participants Achieving Clinical Remission at Week 12

Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

All randomized participants.

Posted

Number

95% Confidence Interval

Percent of Participants

12 weeks after first dose

ID	Title	Description
OG000	Placebo	Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.
OG001	3 mg BMS-986165	BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.
OG002	6 mg BMS-986165	BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.
OG003	12 mg BMS-986165	BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.

Units	Counts
Participants	OG00060 OG00186 OG00284 OG003

Title

Denominators

Categories

Title	Measurements
	OG00028.3(16.9 to 39.7) OG00132.6(22.7 to 42.5) OG00221.4(12.7 to 30.2) 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 OG001		Mantel Haenszel		0.5812	Based on a 2-sided test at a significance level of 0.025.	Risk Difference (RD)	4.3			2-Sided	95	-11.0	19.5			3 mg BMS-986165 (numerator) vs Placebo (denominator)		Superiority	Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).

Primary

Percent of Participants Achieving Endoscopic Response at Week 12

Endoscopic Response is defined as >= 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

All randomized participants.

Posted

Number

95% Confidence Interval

Percent of Participants

12 weeks after first dose

ID	Title	Description
OG000	Placebo	Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.
OG001	3 mg BMS-986165

Secondary

Percent of Participants Achieving Clinical Response at Week 12

Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of ≥ 100 points or a total CDAI score < 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Baseline refers to the initial set of before data collected from participants before starting study treatment.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

All randomized participants.

Posted

Number

95% Confidence Interval

Percent of Participants

12 weeks after first dose

ID	Title	Description
OG000	Placebo	Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.

Secondary

Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12

The Patient Reported Outcomes 2 (PRO2) is a way for patients to report how they're feeling. It focuses on two things: how often they have loose or liquid stools, and how much abdominal pain they have. They keep track of these things every day for a week. Stool frequency is rated on a scale from 0 to 3, with 0 being the normal number of stools per day to 3 which is >/=5 stools more than normal per day. The pain is rated on a scale from 0 to 3, with 0 being no pain and 3 being severe pain. The scores for these two things are added up to get a total score ranging from 0-6. If the average daily score for abdominal pain is 1 or less, and the average number of loose or liquid stools is 3 or less, then the disease might be in remission.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

All randomized participants.

Posted

Number

95% Confidence Interval

Percent of Participants

12 weeks after first dose

ID	Title	Description
OG000	Placebo	Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.

Secondary

Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants starting study treatment.

All randomized participants with available baseline and week 12 SES-CD scores.

Posted

Mean

Standard Deviation

Change in Score on a Scale

12 weeks after first dose

ID	Title	Description
OG000	Placebo	Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.
OG001	3 mg BMS-986165	BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive BMS-986165 6 mg twice daily for up week 104.	60	6	59	33	59
EG001	3 mg BMS-986165	BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily for up to week 104.	86	11	84	55	84
EG002	6 mg BMS-986165	BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52. Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily up to week 104.	84	5	83	55	83
EG003	12 mg BMS-986165	BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg until week 52, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.	9	2	9	7	9
EG004	6 mg BMS-986165 - Open Label	Participants from the Placebo, 3 mg BMS-986165, and 6 mg BMS-986165 arms who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986164 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to begin/continue to receive BMS986165 6 mg twice daily. Participants who were randomized to the 12 mg BMS-986165 arm prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders from this arm who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.	161	15	161	86	161
EG005	12 mg BMS-986165 - Open Label	Participants who took 12 mg BMS-986165 up to week 12/52 who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986164 12 mg once per day until week 104.	6	1	6	3	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG0030 affected9 at risk EG0041 affected161 at risk EG0050 affected6 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected59 at risk EG0015 affected84 at risk EG0022 affected83 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Ileal perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Stomatitis necrotising	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0021 affected83 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0021 affected83 at risk EG003
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Anal abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Breast abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Diabetic foot infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Infectious pleural effusion	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Lung abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Mediastinitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Norovirus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Craniofacial injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0021 affected83 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0021 affected83 at risk EG003
Haematoma	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0021 affected83 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected84 at risk EG0024 affected83 at risk EG0031 affected9 at risk EG0042 affected161 at risk EG0050 affected6 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected59 at risk EG0011 affected84 at risk EG0021 affected83 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected84 at risk EG0020 affected83 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected59 at risk EG0016 affected84 at risk EG0027 affected83 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected59 at risk EG0013 affected84 at risk EG0028 affected83 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 affected59 at risk EG00110 affected84 at risk EG00210 affected83 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0016 affected84 at risk EG0024 affected83 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected59 at risk EG0014 affected84 at risk EG0022 affected83 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected59 at risk EG0011 affected84 at risk EG0020 affected83 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 affected59 at risk EG0012 affected84 at risk EG0022 affected83 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected59 at risk EG0012 affected84 at risk EG0021 affected83 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected59 at risk EG0014 affected84 at risk EG0027 affected83 at risk EG003
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 affected59 at risk EG0015 affected84 at risk EG00211 affected83 at risk EG003
Folliculitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0015 affected84 at risk EG0021 affected83 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected59 at risk EG0016 affected84 at risk EG0025 affected83 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected59 at risk EG0019 affected84 at risk EG0025 affected83 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0022 affected83 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 affected59 at risk EG0015 affected84 at risk EG0026 affected83 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected59 at risk EG0011 affected84 at risk EG0022 affected83 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0014 affected84 at risk EG0022 affected83 at risk EG003
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected59 at risk EG0016 affected84 at risk EG0025 affected83 at risk EG003
Breast haematoma	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0020 affected83 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected59 at risk EG0013 affected84 at risk EG0023 affected83 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected59 at risk EG0012 affected84 at risk EG0026 affected83 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected59 at risk EG0019 affected84 at risk EG00212 affected83 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected59 at risk EG0015 affected84 at risk EG0025 affected83 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected84 at risk EG0021 affected83 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected84 at risk EG0021 affected83 at risk EG003

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