Safety and Efficacy of Adalimumab Versus Ustekinumab for... | NCT03464136

ID	Type	Description	Link
2017-004209-41	EudraCT Number
CNTO1275CRD3007	Other Identifier	Janssen Scientific Affairs, LLC

Label	Type	Description	Intervention Names
Group 1 (Ustekinumab)	Experimental	Participants will receive intravenous (IV) infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 subcutaneous (SC) injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants will self-administer one SC injection of ustekinumab 90 milligram (mg) every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated every 2 weeks (q2w) dosing intervals.	Biological: Placebo for Ustekinumab Biological: Ustekinumab (6 mg/kg) Biological: Ustekinumab (90 mg)
Group 2 (Adalimumab)	Active Comparator	Participants will receive IV infusion of placebo for ustekinumab and 4 SC injections of adalimumab (each 40 mg, total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants will self-administer 1 SC injection of adalimumab 40 mg q2w.	Biological: Placebo for Adalimumab Biological: Adalimumab (40 mg)

Name	Type	Description	Arm Group Labels	Other Names
Placebo for Ustekinumab	Biological	Participants will receive placebo as SC injection to blind adalimumab.	Group 1 (Ustekinumab)

Measure	Description	Time Frame
Percentage of Participants With Clinical Remission at Week 52	Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 52

Measure	Description	Time Frame
Percentage of Participants With Corticosteroid-free Remission at Week 52	Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score <150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Name	Affiliation	Role
Janssen Scientific Affairs, LLC Clinical Trial	Janssen Scientific Affairs, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Medical Group		Mobile	Alabama	36608	United States
Precision Research Institute

PubMed Identifier	Type	Citation	Retractions
41258994	Derived	Venkat S, Zeeman M, Hart A, Bhagat S, Galbraith DA, Hoops T, Ufberg PJ, Izanec J, Freeman TC, Mcrae B, Shinzaki S, Jairath V, Panaccione R, Sands BE, Branigan P. Serum protein profiles differ with adalimumab and ustekinumab treatment in moderately to severely active Crohn's disease. J Crohns Colitis. 2025 Dec 5;19(11):jjaf197. doi: 10.1093/ecco-jcc/jjaf197.
40357993

ID	Title	Description
FG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 14, 2020	Dec 14, 2021

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 at Week 52

Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

Full analysis set (FAS) which was defined as all randomized participants.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Units	Counts
Participants	OG000195 OG001191

Title

Denominators

Categories

Title	Measurements
	OG00061.0 OG00164.9

Secondary

Percentage of Participants With Corticosteroid-free Remission at Week 52

Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score <150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Clinical Response at Week 52

Percentage of participants with clinical response at Week 52 were assessed. Clinical response at Week 52 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52

PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). 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. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP <=1 and SF <=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Clinical Remission at Week 16

Percentage of participants with clinical remission (defined as CDAI <150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of < 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Endoscopic Remission at Week 52

Percentage of participants with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score less than or equal to (<=) 3, or SES-CD =0 for participants who entered the study with a SES-CD =3 at Week 52. 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 56, where higher scores indicate more severe disease.

FAS among participants with SES-CD Score >=3 at Baseline.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Clinical Remission Through Week 52

Percentage of participants with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

Weeks 2, 8, 16, 24, 32, 40, 48, and 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Clinical Response Through Week 52

Percentage of participants with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of >=100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

Weeks 2, 8, 16, 24, 32, 40, 48, and 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Durable Clinical Response at Week 52

Percentage of participants with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI <150 at Week 52 and was >= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Durable Clinical Remission at Week 52

Percentage of participants with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score <150 at Week 52 and was >= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Abdominal Pain (AP) Improvement Through Week 52

Percentage of participants with AP improvement through Week 52 were reported. AP improvement was defined as at least 1 point or greater improvement in mean daily CDAI AP score (ranges from 0 to 3 where higher score indicates severity of pain) from baseline, or a mean score of zero among participants with mean AP>0 at baseline, compared at each visit through Week 52.

FAS among participants with mean daily AP Score >0 at Baseline.

Posted

Number

percentage of participants

Weeks 2, 8, 16, 24, 32, 40, 48, and 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Reduction in Frequency of Diarrhea Through Week 52

Number of participants with reduction in frequency of diarrhea were reported. Reduction in frequency of diarrhea was defined as a reduction of at least 3 (or a mean number <1) in SF (that is, mean daily number of liquid or very soft stools from CDAI score [ranges from 0 to 3 where higher score indicates severity of pain] in the week prior to the visit) from baseline, among subjects with mean SF >1 at baseline, compared at each visit through Week 52.

FAS among participants with mean daily stool frequency >1 at Baseline.

Posted

Number

percentage of participants

Weeks 2, 8, 16, 24, 32, 40, 48, and 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52

Percentage of participants with clinical and biomarker remission was defined as the percentage of participants with CDAI <150, CRP <= 3 mg/L, and also fecal calprotectin <=250 micrograms per gram (mcg/g). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

FAS which was defined as all randomized participants.

Posted

Number

percentage of participants

At Weeks 8, 16 and 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Adverse Events (AEs)

Percentage of participants with AE were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Safety analysis set included all the participants who were randomized and received at least one administration of study agent in the study.

Posted

Number

percentage of participants

Up to Week 52 and up to Week 76

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Secondary

Percentage of Participants With Infections

Percentage of participants with infections were reported.

Safety analysis set included all the participants who were randomized and received at least one administration of study agent in the study.

Posted

Number

percentage of participants

Up to Week 52 and up to Week 76

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Units	Counts

Secondary

Percentage of Participants With Serious Infections

Percentage of participants with serious infections were reported.

Safety analysis set included all the participants who were randomized and received at least one administration of study agent in the study.

Posted

Number

percentage of participants

Up to Week 52 and up to Week 76

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Units	Counts

Secondary

Percentage of Participants With Serious Adverse Events (SAEs)

Percentage of participants with SAEs were reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Coronavirus disease 2019 (COVID-19) related adverse events are adverse events with any of the following preferred terms "COVID-19", "Asymptomatic COVID-19", "Suspected COVID-19", "COVID-19 pneumonia", "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive" or with a reported term containing the string "COVI.

Safety analysis set included all the participants who were randomized and received at least one administration of study agent in the study.

Posted

Number

percentage of participants

Up to Week 52 and up to Week 76

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab

Secondary

Percentage of Participants With Anti-drug Antibodies

Percentage of participants with anti-drug antibodies were reported. Serum samples were assessed for anti-drug antibodies. Anti-drug assays were performed for ustekinumab and adalimumab.

Immunogenicity analysis set included all participants who had received at least 1 administration of study agent and have at least one valid blood sample drawn for detection of antibodies to study agent.

Posted

Number

percentage of participants

Up to Week 52

ID	Title	Description
OG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
OG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Angina Unstable	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Venolymphatic Malformation	Congenital, familial and genetic disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected195 at risk EG0015 affected191 at risk
Duodenal Stenosis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Ileal Stenosis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Intestinal Stenosis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Intussusception	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Large Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Subileus	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Sudden Death	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Jaundice	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Abdominal Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Anal Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Appendicitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
COVID-19	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Diverticulitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Epididymitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Paracoccidioides Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Rectal Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Crush Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Dizziness Postural	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Epilepsy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Migraine	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Thrombophlebitis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected195 at risk EG0016 affected191 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Extrasystoles	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Palpitations	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Syringomyelia	Congenital, familial and genetic disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Ear Haemorrhage	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Ear Swelling	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0017 affected191 at risk
Blepharospasm	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Cataract	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Choroidal Effusion	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Conjunctivitis Allergic	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Dry Eye	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Eye Pruritus	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Eyelid Cyst	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Eyelid Oedema	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Foreign Body Sensation in Eyes	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Glaucoma	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Iridocyclitis	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Iritis	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Keratitis	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Retinal Detachment	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Swelling of Eyelid	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Uveitis	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Vision Blurred	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0011 affected191 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0012 affected191 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00016 affected195 at risk EG00125 affected191 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected195 at risk EG0017 affected191 at risk
Abdominal Tenderness	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Anal Fissure	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0017 affected191 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Anal Pruritus	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Anal Stenosis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Anorectal Discomfort	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Chronic Gastritis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected195 at risk EG0017 affected191 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00029 affected195 at risk EG00120 affected191 at risk
Defaecation Urgency	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Dental Caries	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG00111 affected191 at risk
Diarrhoea Haemorrhagic	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0014 affected191 at risk
Enlarged Uvula	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Eosinophilic Oesophagitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Flatulence	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0014 affected191 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Frequent Bowel Movements	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected195 at risk EG0016 affected191 at risk
Gingival Swelling	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Haematochezia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0013 affected191 at risk
Ileal Stenosis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Large Intestinal Stenosis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Lip Blister	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Mouth Ulceration	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected195 at risk EG00112 affected191 at risk
Proctitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Rectal Tenesmus	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Subileus	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Toothache	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG00111 affected191 at risk
Asthenia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Chest Discomfort	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Drug Intolerance	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Fatigue	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0018 affected191 at risk
Impaired Healing	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Influenza Like Illness	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Injection Site Bruising	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Injection Site Erythema	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00013 affected195 at risk EG0013 affected191 at risk
Injection Site Haematoma	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Injection Site Irritation	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Injection Site Oedema	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0010 affected191 at risk
Injection Site Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0011 affected191 at risk
Injection Site Pruritus	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected195 at risk EG0012 affected191 at risk
Injection Site Rash	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Injection Site Reaction	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Injection Site Swelling	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0010 affected191 at risk
Malaise	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Medical Device Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Oedema Peripheral	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0015 affected191 at risk
Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Peripheral Swelling	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0012 affected191 at risk
Pyrexia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected195 at risk EG0016 affected191 at risk
Suprapubic Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Vessel Puncture Site Haematoma	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Cholangitis Sclerosing	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Hepatic Steatosis	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Jaundice	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Seasonal Allergy	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Abdominal Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Abscess Limb	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Abscess Oral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Acute Sinusitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Anal Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0012 affected191 at risk
Bacterial Vulvovaginitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Blister Infected	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Bronchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0010 affected191 at risk
Bronchitis Bacterial	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
COVID-19	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0011 affected191 at risk
Candida Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Cellulitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Cervicitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Conjunctivitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Cystitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Dermatophytosis of Nail	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Ear Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0013 affected191 at risk
Eczema Infected	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Eye Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Folliculitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Fungal Skin Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Furuncle	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0013 affected191 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Gastrointestinal Bacterial Overgrowth	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Gastrointestinal Viral Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Genital Herpes	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Hepatitis E	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Herpes Zoster Disseminated	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Influenza	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected195 at risk EG0016 affected191 at risk
Large Intestine Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Laryngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Latent Tuberculosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Localised Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00020 affected195 at risk EG00114 affected191 at risk
Onychomycosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Oral Candidiasis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Oral Herpes	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected195 at risk EG0011 affected191 at risk
Oropharyngeal Candidiasis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Otitis Externa	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Otitis Media	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Pharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Post Procedural Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Rectal Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Respiratory Syncytial Virus Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0011 affected191 at risk
Rhinitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0012 affected191 at risk
Salmonellosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Septic Shock	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Sinobronchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Sinusitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected195 at risk EG0013 affected191 at risk
Staphylococcal Skin Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Streptococcal Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Suspected COVID-19	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Tonsillitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0013 affected191 at risk
Tooth Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Tooth Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Tracheobronchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00015 affected195 at risk EG00113 affected191 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected195 at risk EG0017 affected191 at risk
Vaginal Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Viral Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0013 affected191 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0012 affected191 at risk
Vulvitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Vulvovaginal Candidiasis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0014 affected191 at risk
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Exposure to Toxic Agent	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Foreign Body in Eye	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0012 affected191 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Post Procedural Inflammation	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Procedural Anxiety	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Procedural Dizziness	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Splinter	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Tooth Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected195 at risk EG0012 affected191 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0013 affected191 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Blood Folate Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Blood Glucose Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Blood Phosphorus Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Blood Pressure Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Blood Testosterone Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Body Temperature Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
C-Reactive Protein Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0012 affected191 at risk
Colonoscopy Abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Faecal Calprotectin Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Granulocyte Count Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Haematocrit Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Heart Rate Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Hepatic Enzyme Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Human Chorionic Gonadotropin Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Liver Function Test Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0012 affected191 at risk
Mycobacterium Tuberculosis Complex Test Positive	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Transaminases Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Urine Output Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Vitamin B12 Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Weight Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0010 affected191 at risk
Weight Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
White Blood Cell Count Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Folate Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Hypoferritinaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Hypovitaminosis	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Impaired Fasting Glucose	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Vitamin B12 Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0015 affected191 at risk
Ankylosing Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00015 affected195 at risk EG00113 affected191 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Arthritis Enteropathic	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0018 affected191 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Diastasis Recti Abdominis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Lupus-Like Syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0012 affected191 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0013 affected191 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Plantar Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Psoriatic Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
SAPHO Syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Spinal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Temporomandibular Joint Syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Tenosynovitis Stenosans	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Benign Neoplasm of Eye	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Colon Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Dysplastic Naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Seborrhoeic Keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Amnesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Cervical Radiculopathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Dizziness	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Dizziness Postural	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0014 affected191 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Headache	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00014 affected195 at risk EG00125 affected191 at risk
Hemiplegic Migraine	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Lethargy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Memory Impairment	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Migraine	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected191 at risk
Migraine with Aura	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Nerve Compression	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Presyncope	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Sciatica	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0013 affected191 at risk
Sinus Headache	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0014 affected191 at risk
Syncope	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Tension Headache	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Tremor	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Affect Lability	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Anxiety	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0016 affected191 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Depressed Mood	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Depression	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0012 affected191 at risk
Insomnia	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0011 affected191 at risk
Panic Attack	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Sleep Disorder	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Stress	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Azotaemia	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Dysuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Nocturia	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Cervical Dysplasia	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Nipple Pain	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Semen Discolouration	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Vulvovaginal Discomfort	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Asthma Late Onset	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected195 at risk EG0013 affected191 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0014 affected191 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected191 at risk
Nasal Crusting	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0019 affected191 at risk
Pharyngeal Inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0013 affected191 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0012 affected191 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0017 affected191 at risk
Brow Ptosis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0014 affected191 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0014 affected191 at risk
Eczema Nummular	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected195 at risk EG0010 affected191 at risk
Erythema Nodosum	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Post Inflammatory Pigmentation Change	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0012 affected191 at risk
Pseudofolliculitis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected195 at risk EG0012 affected191 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected195 at risk EG0013 affected191 at risk
Rash Erythematous	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Rash Papular	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Scar Pain	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Sebaceous Hyperplasia	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Seborrhoeic Dermatitis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Skin Exfoliation	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0011 affected191 at risk
Skin Fissures	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected191 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected191 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected195 at risk EG0012 affected191 at risk
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Tonsillectomy	Surgical and medical procedures	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Aortic Arteriosclerosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Flushing	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected191 at risk
Hot Flush	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk
Hypertension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected195 at risk EG0013 affected191 at risk
Raynaud's Phenomenon	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected191 at risk

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

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
BG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Adalimumab	Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).	1	195	38	195	151	195
EG001	Ustekinumab	Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.	0	191	29	191	152	191