An Extension Study of Oral Ozanimod for Moderately to Sev... | NCT03467958

ID	Type	Description	Link
U1111-1203-8203	Registry Identifier	WHO
2017-004295-55	EudraCT Number

Label	Type	Description	Intervention Names
Administration of oral Ozanimod	Experimental		Drug: Ozanimod

Name	Type	Description	Arm Group Labels	Other Names
Ozanimod	Drug	Specified dose on specified days	Administration of oral Ozanimod

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinical Remission	Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.	At weeks 48, 96, 144, 192, 240
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.	From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission	Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. Higher scores indicated worse outcomes.

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

Facility	Status	City	State	ZIP	Country	Contacts
Holland Center for Family Health		Peoria	Arizona	85381	United States
Local Institution - 202

PubMed Identifier	Type	Citation	Retractions
36208720	Derived	Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	RPC01-3201/3202 Placebo	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
FG001	RPC01-3201/3202 Ozanimod 0.92 mg

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 16, 2023

Arm/Group Information

ID	Title	Description
BG000	RPC01-3201/3202 Placebo	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG001	RPC01-3201/3202 Ozanimod 0.92 mg	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG002	RPC01-3203 Placebo-Placebo Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG003	RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG004	RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG005	RPC01-3203 Placebo-Placebo Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG006	RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG007	RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG008	RPC01-2201 Ozanimod 0.92 mg	Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
BG009	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

Percentage of Participants With Clinical Remission

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

All treated participants

Posted

Number

Percentage of participants

At weeks 48, 96, 144, 192, 240

ID	Title	Description
OG000	RPC01-3201/3202 Placebo	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG001	RPC01-3201/3202 Ozanimod 0.92 mg	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG002	RPC01-3203 Placebo-Placebo Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG003	RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG004	RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG005	RPC01-3203 Placebo-Placebo Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG006	RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG007	RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG008	RPC01-2201 Ozanimod 0.92 mg	Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.

Units	Counts
Participants	OG000179 OG001329 OG00266 OG003

Title

Denominators

Categories

Week 48

Title	Measurements
	OG00019.6 OG00121.0 OG00260.6 OG003

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.

All treated participants

Posted

Count of Participants

Participants

From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)

ID	Title	Description
OG000	RPC01-3201/3202 Placebo	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG001	RPC01-3201/3202 Ozanimod 0.92 mg	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.

Secondary

Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission

Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. Higher scores indicated worse outcomes.

All treated participants

Posted

Number

Percentage of participants

At weeks 48, 96, 144, 192, 240

ID	Title	Description
OG000	RPC01-3201/3202 Placebo	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG001	RPC01-3201/3202 Ozanimod 0.92 mg	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG002	RPC01-3203 Placebo-Placebo Completers

Secondary

Percentage of Participants With Clinical Response

Clinical response is defined as a Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of < 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

All treated participants

Posted

Number

Percentage of participants

At weeks 48, 96, 144, 192, 240

ID	Title	Description
OG000	RPC01-3201/3202 Placebo	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
OG001	RPC01-3201/3202 Ozanimod 0.92 mg	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RPC01-3201/3202 Placebo	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	0	179	38	179	104	179
EG001	RPC01-3201/3202 Ozanimod 0.92 mg	Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	0	329	59	329	181	329
EG002	RPC01-3203 Placebo-Placebo Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	0	66	9	66	24	66
EG003	RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	0	85	11	85	44	85
EG004	RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers	Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	1	91	11	91	38	91
EG005	RPC01-3203 Placebo-Placebo Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	0	38	6	38	22	38
EG006	RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	0	33	4	33	15	33
EG007	RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse	Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	0	20	2	20	14	20
EG008	RPC01-2201 Ozanimod 0.92 mg	Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.	0	13	2	13	10	13

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG0030 affected85 at risk EG0041 affected91 at risk EG0050 affected38 at risk EG0060 affected33 at risk EG0070 affected20 at risk EG0080 affected13 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0021 affected66 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Urachal abnormality	Congenital, familial and genetic disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Macular oedema	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Retinal degeneration	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Retinal detachment	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Anal cyst	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00022 affected179 at risk EG00124 affected329 at risk EG0021 affected66 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Enterocolonic fistula	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Ileal stenosis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Intestinal fistula	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Intestinal mass	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0021 affected66 at risk EG003
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0011 affected329 at risk EG0022 affected66 at risk EG003
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Peripheral swelling	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Anal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Anal fistula infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Appendicitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Campylobacter infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Colonic abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Leptospirosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0021 affected66 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0021 affected66 at risk EG003
Pilonidal disease	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0021 affected66 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Pneumonia haemophilus	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Psoas abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Rectal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Retroperitoneal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Gastrointestinal anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0021 affected66 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0021 affected66 at risk EG003
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Vitamin B complex deficiency	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Aphasia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0007 affected179 at risk EG00117 affected329 at risk EG0023 affected66 at risk EG0038 affected85 at risk EG0044 affected91 at risk EG0051 affected38 at risk EG0062 affected33 at risk EG0070 affected20 at risk EG0080 affected13 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected179 at risk EG0018 affected329 at risk EG0021 affected66 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00013 affected179 at risk EG00143 affected329 at risk EG0023 affected66 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Epiretinal membrane	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Visual impairment	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00010 affected179 at risk EG00118 affected329 at risk EG0024 affected66 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0016 affected329 at risk EG0020 affected66 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0014 affected329 at risk EG0023 affected66 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00033 affected179 at risk EG00136 affected329 at risk EG0023 affected66 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 affected179 at risk EG00111 affected329 at risk EG0022 affected66 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0013 affected329 at risk EG0020 affected66 at risk EG003
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected179 at risk EG00110 affected329 at risk EG0021 affected66 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected179 at risk EG0012 affected329 at risk EG0021 affected66 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0013 affected329 at risk EG0020 affected66 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected179 at risk EG00111 affected329 at risk EG0021 affected66 at risk EG003
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0016 affected329 at risk EG0021 affected66 at risk EG003
Medical device pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Peripheral swelling	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0012 affected329 at risk EG0021 affected66 at risk EG003
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG00011 affected179 at risk EG00111 affected329 at risk EG0020 affected66 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Metabolic dysfunction-associated steatohepatitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 affected179 at risk EG0013 affected329 at risk EG0020 affected66 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00016 affected179 at risk EG00125 affected329 at risk EG0025 affected66 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0010 affected329 at risk EG0021 affected66 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 affected179 at risk EG0013 affected329 at risk EG0020 affected66 at risk EG003
Lice infestation	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0008 affected179 at risk EG00117 affected329 at risk EG0021 affected66 at risk EG003
Pericoronitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 affected179 at risk EG0019 affected329 at risk EG0020 affected66 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0009 affected179 at risk EG00118 affected329 at risk EG0021 affected66 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 affected179 at risk EG0019 affected329 at risk EG0020 affected66 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Blood fibrinogen increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0021 affected66 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00015 affected179 at risk EG00120 affected329 at risk EG0021 affected66 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0015 affected329 at risk EG0022 affected66 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0021 affected66 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00016 affected179 at risk EG00111 affected329 at risk EG0023 affected66 at risk EG003
Morton's neuralgia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected179 at risk EG0015 affected329 at risk EG0021 affected66 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0012 affected329 at risk EG0020 affected66 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected179 at risk EG0015 affected329 at risk EG0022 affected66 at risk EG003
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0011 affected329 at risk EG0021 affected66 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0013 affected329 at risk EG0020 affected66 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected179 at risk EG0010 affected329 at risk EG0020 affected66 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0011 affected329 at risk EG0020 affected66 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected179 at risk EG0013 affected329 at risk EG0020 affected66 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected179 at risk EG0014 affected329 at risk EG0022 affected66 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected179 at risk EG00111 affected329 at risk EG0024 affected66 at risk EG003

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