NCT04677179 · Consolidated SoA

Activities:

Near match across tables

Near match, different parent

| Annotations:

³ click for the text

in Unified Annotations: show where it applies

| Cells:

Common

Responders only

Nonresponders only

Early Termination / only

▼ Main Schedule (9 columns)

Activity

Table 1

Visit number
[visit] L1

V1¹

V9¹

Weeks from randomization
[week] L2

–5

—

Study day
[study_day] L3

—

Visit interval tolerance (days)
[window]

≤35 before V2

—

±3

Fasting visit⁴⁹
[visit_attribute]

Study day
[study_day]

Informed consent

Site staff explains, participant reports remission/normal stool frequency⁴

Inclusion and exclusion criteria, review and confirm

Demographics

Preexisting conditions and medical history⁵

Prespecified medical history⁶

Prior treatments for indication⁷

Concomitant medications

T1,T2,T3,T4

Adverse events⁸

T1,T2,T3,T4

Review modified Mayo score (MMS)

T1,T2,T3,T4

Tobacco use

T1,T2,T3,T4

Alcohol and caffeine use

Physical Evaluation

T1,T2,T3,T4

Height⁹

Weight

T1,T2,T3,T4

Vital signs^10,37

T1,T2,T3,T4

Physical examination¹¹

Symptom-directed physical examination, including assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes¹²

T1,T2,T3,T4

CCI

T1,T2,T3,T4

12-lead electrocardiogram (ECG)¹³

T1,T2,T3,T4

Chest x-ray (posterior-anterior view)¹⁴

Patient Diary (Electronic)

T1,T2,T3,T4

Patient diary dispensed

Diary compliance check¹⁵

T1,T2,T3

Patient-Reported Outcomes (Electronic)

T1,T2,T3,T4

Inflammatory Bowel Disease Questionnaire (IBDQ)

T1,T2,T3,T4

Patient Global Impression of Change (PGI-C)

T1,T2,T3,T4

QIDS-SR16

T1,T2,T3,T4

Clinician-Administered Questionnaires (Paper)

T1,T2,T3,T4

Physician’s Global Assessment (PGA)

T1,T2,T3,T4

C-SSRS Screening/Baseline¹⁶

Self-Harm Supplement Form

Self-Harm Follow-Up Form¹⁷

Laboratory Tests and Sample Collections

T1,T2,T3,T4

Hematology

T1,T2,T3,T4

Clinical chemistry

T1,T2,T3,T4

Lipid panel^18,38

T1,T2,T3,T4

Urinalysis

T1,T2,T3,T4

Serum pregnancy¹⁹

Urine pregnancy (local)^20,45

T1,T2,T3,T4

Follicle-stimulating hormone (FSH)²¹

CCI²⁶

T1,T2,T3,T4

Tuberculosis (TB) test²²

Human immunodeficiency virus (HIV) screening tests

Hepatitis C virus (HCV) screening tests²³

Hepatitis B virus (HBV) screening tests²⁴

HBV DNA²⁵

T1,T2,T3,T4

Pharmacokinetic (PK) samples²⁶

T1,T2,T3,T4

CCI²⁶

T1,T2,T3,T4

Flow cytometry panel

T1,T2,T3,T4

Genetics sample²⁷

T1,T2,T3,T4

CCI

T1,T2,T3,T4

Endoscopic Procedure⁴⁰

T1,T2,T3,T4

Endoscopy²⁸

T1,T2,T3,T4

Colon biopsy sample collection^29,55

T1,T2,T3,T4

Stool Samples

T1,T2,T3,T4

Stool culture³⁰

C. difficile testing³¹

CCI

T1,T2,T3,T4

CCI

T1,T2,T3,T4

Randomization and Dosing

T1,T2,T3,T4

Randomization

Dosing^32,39,53

T1,T2,T3,T4

▼ Track Timelines: Early Termination / Unscheduled / Post-Treatment, Nonresponders, Responders (44 columns)

Activity

Table 2

Table 3

Table 4

Responders

Nonresponders

Early Termination / Unscheduled / Post-Treatment

Visit number
[visit] L1

V10³⁵

V11³⁵

V12³⁵

V13³⁵

V14³⁵

V15³⁵

V16³⁵

V17³⁵

V18³⁵

V19³⁵

V20³⁶

V21³⁶

V22³⁶

V23³⁶

V24³⁶

V25³⁶

V26³⁶

V27³⁶

V28³⁶

V29

V10

V11

V12

V13

V14

V15

V16⁴⁴

V17⁴²

V18⁴²

V19⁴²

V20⁴³

V21⁴³

V22⁴³

V23⁴³

V24⁴³

V25⁴³

V26⁴³

V27⁴³

V28⁴³

V29

ETV

V997⁴⁷

V801⁴⁸

V802^46,48

Weeks from randomization
[week] L2

—

58 or ETV + 8 weeks after last dose

66 or ETV + 16 weeks after last dose

Study day
[study_day] L3

113

127

141

155

169

183

197

211

225

239

253

267

281

295

309

323

337

351

365

113

127

141

155

169

183

197

211

225

239

253

267

281

295

309

323

337

351

365

Study day
[study_day]

—

Fasting visit⁴⁹
[visit_attribute]

Visit interval tolerance (days)
[window]

±3

—

±7

Concomitant medications

T1,T2,T3,T4

Adverse events⁸

T1,T2,T3,T4

Review modified Mayo score (MMS)

T1,T2,T3,T4

Tobacco use

T1,T2,T3,T4

Physical Evaluation

T1,T2,T3,T4

Weight

T1,T2,T3,T4

Vital signs^10,37

T1,T2,T3,T4

X⁵⁴

Symptom-directed physical examination, including assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes¹²

T1,T2,T3,T4

CCI

T1,T2,T3,T4

12-lead electrocardiogram (ECG)¹³

T1,T2,T3,T4

Patient Diary (Electronic)

T1,T2,T3,T4

Diary compliance check¹⁵

T1,T2,T3

Diary return

T2,T3,T4

Patient-Reported Outcomes (Electronic)

T1,T2,T3,T4

Inflammatory Bowel Disease Questionnaire (IBDQ)

T1,T2,T3,T4

Patient Global Impression of Change (PGI-C)

T1,T2,T3,T4

QIDS-SR16

T1,T2,T3,T4

Clinician-Administered Questionnaires (Paper)

T1,T2,T3,T4

Physician’s Global Assessment (PGA)

T1,T2,T3,T4

Laboratory Tests and Sample Collections

T1,T2,T3,T4

Hematology

T1,T2,T3,T4

Clinical chemistry

T1,T2,T3,T4

Lipid panel^18,38

T1,T2,T3,T4

X⁵⁰

Urinalysis

T1,T2,T3,T4

Urine pregnancy (local)^20,45

T1,T2,T3,T4

CCI²⁶

T1,T2,T3,T4

HBV DNA²⁵

T1,T2,T3,T4

Pharmacokinetic (PK) samples²⁶

T1,T2,T3,T4

CCI²⁶

T1,T2,T3,T4

Flow cytometry panel

T1,T2,T3,T4

Genetics sample²⁷

T1,T2,T3,T4

CCI

T1,T2,T3,T4

Endoscopic Procedure⁴⁰

T1,T2,T3,T4

Endoscopy²⁸

T1,T2,T3,T4

X⁵¹

Colon biopsy sample collection^29,55

T1,T2,T3,T4

X^52,56

Stool Samples

T1,T2,T3,T4

CCI

T1,T2,T3,T4

CCI

T1,T2,T3,T4

Randomization and Dosing

T1,T2,T3,T4

Dosing^32,39,53

T1,T2,T3,T4

▼ Matches across tables no matches to review

Rows that consolidation merged on name similarity, or kept separate from a near match. Whether two rows are the same activity is the reviewer's call: choosing drafts an entry for NCT04677179_consolidation_corrections.json below; nothing is saved from here. Rows merged on an identical name are not listed. Words that only one of the two names prints are marked; the score ignores case, hyphens, slashes, text in parentheses and plural endings.

Refinements: a table or row that details a row of another table, without being the same activity. A cross-reference note can draft the entry once the table it means is picked; row-to-row entries are written by hand.

state	refining side		row	draft
source note	2 “For procedures at an ETV, see ETV in Table 4.”	points from	table-wide note, bound to no row	names Table 4; no row to state a refinement on
source note	3 “For procedures at an unscheduled visit, see V997 in Table 4.”	points from	table-wide note, bound to no row	names Table 4; no row to state a refinement on
source note	34 “For procedures at an early termination visit, see ETV in Table 4.”	points from	table-wide note, bound to no row	names Table 4; no row to state a refinement on

Draft — new file consolidated/NCT04677179_consolidation_corrections.json; replace each <why>, then re-run consolidation.

▼ Consolidation Metadata Process information

consolidated_at	2026-10-03T19:23:37.349415+00:00
source_activity_count	182
unified_activity_count	64
compression_percent	65
match_stats	exact: 118, new: 64

▼ Source Tables 4 tables

table	type	track	title / purpose	acts	cols	props
T1	main_soa		Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH Screening (V1) and induction treatment (V2-V9, Weeks 0-12) schedule for all participants	63	9	5
T2	track	Responders	Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH Maintenance treatment period (V10-V29, Weeks 14-52) for participants who are responders at Week 12	40	20	5
T3	track	Nonresponders	Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH Extension induction and extension maintenance periods (V10-V29, Weeks 14-52) for participants who are nonresponders at Week 12	40	20	5
T4	track	Early Termination / Unscheduled / Post-Treatment	Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period Early termination visit (ETV), unscheduled visit (V997) and post-treatment follow-up visits (V801, V802)	39	4	5

▼ Unified Activities 64 activities

xact_id	activity_name (variations)	parent	match	#	tables	row kind
xact-001	Informed consent		one table	1	T1
xact-002	Site staff explains, participant reports remission/normal stool frequency		one table	1	T1
xact-003	Inclusion and exclusion criteria, review and confirm		one table	1	T1
xact-004	Demographics		one table	1	T1
xact-005	Preexisting conditions and medical history		one table	1	T1
xact-006	Prespecified medical history		one table	1	T1
xact-007	Prior treatments for indication		one table	1	T1
xact-008	Concomitant medications		same name	4	T1, T2, T3, T4
xact-009	Adverse events		same name	4	T1, T2, T3, T4
xact-010	Review modified Mayo score (MMS)		same name	4	T1, T2, T3, T4
xact-011	Tobacco use		same name	4	T1, T2, T3, T4
xact-012	Alcohol and caffeine use		one table	1	T1
xact-013	Physical Evaluation		same name	4	T1, T2, T3, T4	section
xact-014	Height	Physical Evaluation	one table	1	T1
xact-015	Weight	Physical Evaluation	same name	4	T1, T2, T3, T4
xact-016	Vital signs	Physical Evaluation	same name	4	T1, T2, T3, T4
xact-017	Physical examination	Physical Evaluation	one table	1	T1
xact-018	Symptom-directed physical examination, including assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes	Physical Evaluation	same name	4	T1, T2, T3, T4
xact-019	CCI	Physical Evaluation	same name	4	T1, T2, T3, T4
xact-020	12-lead electrocardiogram (ECG)	Physical Evaluation	same name	4	T1, T2, T3, T4
xact-021	Chest x-ray (posterior-anterior view)	Physical Evaluation	one table	1	T1
xact-022	Patient Diary (Electronic)		same name	4	T1, T2, T3, T4	section
xact-023	Patient diary dispensed	Patient Diary (Electronic)	one table	1	T1
xact-024	Diary compliance check	Patient Diary (Electronic)	same name	3	T1, T2, T3
xact-064	Diary return	Patient Diary (Electronic)	same name	3	T2, T3, T4
xact-025	Patient-Reported Outcomes (Electronic)		same name	4	T1, T2, T3, T4	section
xact-026	Inflammatory Bowel Disease Questionnaire (IBDQ)	Patient-Reported Outcomes (Electronic)	same name	4	T1, T2, T3, T4
xact-027	Patient Global Impression of Change (PGI-C)	Patient-Reported Outcomes (Electronic)	same name	4	T1, T2, T3, T4
xact-028	QIDS-SR16	Patient-Reported Outcomes (Electronic)	same name	4	T1, T2, T3, T4
xact-029	Clinician-Administered Questionnaires (Paper)		same name	4	T1, T2, T3, T4	section
xact-030	Physician’s Global Assessment (PGA)	Clinician-Administered Questionnaires (P	same name	4	T1, T2, T3, T4
xact-031	C-SSRS Screening/Baseline	Clinician-Administered Questionnaires (P	one table	1	T1
xact-032	Self-Harm Supplement Form	Clinician-Administered Questionnaires (P	one table	1	T1
xact-033	Self-Harm Follow-Up Form	Clinician-Administered Questionnaires (P	one table	1	T1
xact-034	Laboratory Tests and Sample Collections		same name	4	T1, T2, T3, T4	section
xact-035	Hematology	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-036	Clinical chemistry	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-037	Lipid panel	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-038	Urinalysis	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-039	Serum pregnancy	Laboratory Tests and Sample Collections	one table	1	T1
xact-040	Urine pregnancy (local)	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-041	Follicle-stimulating hormone (FSH)	Laboratory Tests and Sample Collections	one table	1	T1
xact-042	CCI	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-043	Tuberculosis (TB) test	Laboratory Tests and Sample Collections	one table	1	T1
xact-044	Human immunodeficiency virus (HIV) screening tests	Laboratory Tests and Sample Collections	one table	1	T1
xact-045	Hepatitis C virus (HCV) screening tests	Laboratory Tests and Sample Collections	one table	1	T1
xact-046	Hepatitis B virus (HBV) screening tests	Laboratory Tests and Sample Collections	one table	1	T1
xact-047	HBV DNA	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-048	Pharmacokinetic (PK) samples	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-049	CCI	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-050	Flow cytometry panel	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-051	Genetics sample	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-052	CCI	Laboratory Tests and Sample Collections	same name	4	T1, T2, T3, T4
xact-053	Endoscopic Procedure		same name	4	T1, T2, T3, T4	section
xact-054	Endoscopy	Endoscopic Procedure	same name	4	T1, T2, T3, T4
xact-055	Colon biopsy sample collection	Endoscopic Procedure	same name	4	T1, T2, T3, T4
xact-056	Stool Samples		same name	4	T1, T2, T3, T4	section
xact-057	Stool culture	Stool Samples	one table	1	T1
xact-058	C. difficile testing	Stool Samples	one table	1	T1
xact-059	CCI	Stool Samples	same name	4	T1, T2, T3, T4
xact-060	CCI	Stool Samples	same name	4	T1, T2, T3, T4
xact-061	Randomization and Dosing		same name	4	T1, T2, T3, T4	section
xact-062	Randomization	Randomization and Dosing	one table	1	T1
xact-063	Dosing	Randomization and Dosing	same name	4	T1, T2, T3, T4

▼ Unified Annotations 56 annotations (36% dedup from 88)

Footnote (52)

xannot_id	markers	#	text	scope	points to
xannot-001 1	T1:t1	1	V1 and V9 procedures may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance and all scheduled activities are completed prior to dosing.	V1 \| V9
xannot-004 4	T1:c1	1	The purpose of UC remission question should be explained before the participant answers the question. Errors in the response cannot be corrected after the participant saves and confirms the response.	Site staff explains, participant reports remission/normal stool frequency
xannot-005 5	T1:c2	1	Includes relevant surgical history.	Preexisting conditions and medical history
xannot-006 6	T1:c3	1	Indication and history of interest.	Prespecified medical history
xannot-007 7	T1:c4	1	Includes all UC-specific therapies since date of diagnosis.	Prior treatments for indication
xannot-008 8	T1-3:c5, T4:c3	4	For AESIs, additional data are collected (Section 8.3.6).	Adverse events	Section 8.3.6
xannot-009 9	T1:c6	1	Participant should remove shoes.	Height
xannot-010 10	T1:c7	1	Blood pressure, body temperature, and pulse rate. Vital signs should be measured after participant has been sitting at least 5 minutes.	Vital signs
xannot-011 11	T1:c8	1	The complete physical exam excludes pelvic, rectal, and breast exams, unless clinically indicated, and includes assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes. See Section 8.2.2.	Physical examination	Section 8.2.2
xannot-013 13	T1-3:c10, T4:c6	4	Locally performed.	12-lead electrocardiogram (ECG)
xannot-014 14	T1:c11	1	Interpreted and reported by radiologist or pulmonologist. Not done at screening if done within 3 months before screening and if qualifying radiographs or equivalent imaging study and/or formal report are available for investigator’s review. Lateral view may also be taken. Locally performed.	Chest x-ray (posterior-anterior view)
xannot-015 15	T1-3:c12	3	Check compliance for Stool Frequency Rectal Bleeding Nocturnal Stools Bristol Stool Scale Urgency NRS Abdominal Pain NRS Fatigue NRS, and Patient Global Rating of Severity (PGR-S).	Diary compliance check
xannot-016 16	T1:c13	1	Adapted for the assessment of ideation and behavior categories only.	C-SSRS Screening/Baseline
xannot-017 17	T1:c14	1	Required if triggered by the Self-Harm Supplement Form per instructions.	Self-Harm Follow-Up Form
xannot-018 18	T1:c15	1	Fasting samples are preferred, but if participant is non fasting at time of collection, this is not a protocol deviation.	Lipid panel
xannot-019 19	T1:c16	1	Perform only for women of childbearing potential and women with a history of tubal ligation.	Serum pregnancy
xannot-020 20	T1-2:c17	2	Perform only for women of childbearing potential and women with a history of tubal ligation. At dosing visits which have pregnancy testing, the pregnancy test result must be confirmed to be negative prior to dosing. Pregnancy testing may be performed more frequently than designated on the SoA, if local laws or regulations require more frequent testing.	Urine pregnancy (local)
xannot-021 21	T1:c18	1	Optional, perform only for women not of childbearing potential to confirm postmenopausal status.	Follicle-stimulating hormone (FSH)
xannot-022 22	T1:c19	1	Patients who had a tuberculin skin test (TST) will return from 48 to 72 hours after placement to have the test result read. Samples may be sent to central or local laboratory based on the type of test. A local laboratory must be qualified by local regulations.	Tuberculosis (TB) test
xannot-023 23	T1:c20	1	HCV RNA will be measured to confirm positive hepatitis C virus antibody.	Hepatitis C virus (HCV) screening tests
xannot-024 24	T1:c21	1	Includes testing for HBsAg and anti-HBc.	Hepatitis B virus (HBV) screening tests
xannot-025 25	T1-3:c22, T4:c9	4	Only for participants who are positive for anti-HBc at screening.	HBV DNA
xannot-026 26	T1-3:c23, T4:c10	4	Collect samples before dosing, if dosing is scheduled. Collect additional samples at specified times relative to onset of hypersensitivity events.	Pharmacokinetic (PK) samples \| CCI \| CCI
xannot-027 27	T1-3:c24, T4:c11	4	Blood sample for DNA pharmacogenetics can be obtained any time at or after V2.	Genetics sample
xannot-028 28	T1:c25	1	Screening endoscopy must occur ≤14 days prior to randomization. At screening, perform only for participants who are eligible for the study by all other study entry criteria.	Endoscopy
xannot-029 29	T1-3:c26	3	Performed at time of endoscopy. Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed.	Colon biopsy sample collection
xannot-030 30	T1:c27	1	Additional local stool testing (for example, for ova and parasites) is allowed at the investigator’s discretion.	Stool culture
xannot-031 31	T1:c28	1	Additional C. difficile testing is allowed throughout the study at the investigator’s discretion.	C. difficile testing
xannot-032 32	T1:c29	1	No dosing at V3.	Dosing
xannot-033 33	T2:t1	1	This schedule applies to study participants who are responders at Week 12.	table
xannot-035 35	T2:t5	1	Visits 10 through 28 are eligible to be conducted remotely (that is, by telephone, IT-assisted virtual visit, mobile healthcare, or a combination thereof), if written approval is provided by the sponsor and according to the preferences of the participant and the study site. However, no more than 34 days can elapse without an on-site study visit occurring.	V10 \| V11 \| V12 \| V13 \| V14 (+5)
xannot-036 36	T2:t6	1	Visits 10 through 28 are eligible to be conducted remotely (that is, by telephone, IT-assisted virtual visit, mobile healthcare, or a combination thereof) if written approval is provided by the sponsor and according to the preferences of the participant and the study site. However, no more than 34 days can elapse without an on-site study visit occurring.	V20 \| V21 \| V22 \| V23 \| V24 (+4)
xannot-037 37	T2-3:c7, T4:c4	3	Blood pressure, body temperature, and pulse rate. Vital signs should be measured after participant has been sitting for at least 5 minutes.	Vital signs
xannot-038 38	T2-3:c15	2	Fasting samples are preferred, but if participant is nonfasting at time of collection, this is not a protocol deviation.	Lipid panel
xannot-039 39	T2-3:c29	2	No dosing at V29.	Dosing
xannot-040 40	T2:c30	1	Not applicable for responders during the time period of V10 through V19	Endoscopic Procedure
xannot-041 41	T3:t1	1	This schedule applies to study participants who are nonresponders at Week 12.	table
xannot-042 42	T3:t5	1	Visits 17 through 28 are eligible to be conducted remotely (that is, by telephone, IT-assisted virtual visit, mobile healthcare, or a combination thereof) if written approval is provided by the sponsor and according to the preferences of the participant and the study site. However, no more than 34 days can elapse without an on-site study visit occurring.	V17 \| V18 \| V19
xannot-043 43	T3:t6	1	Visits 17 through 28 are eligible to be conducted remotely (that is, by telephone, IT-assisted virtual visit, mobile healthcare, or a combination thereof) if written approval is provided by the sponsor and according to the preferences of the participant and the study site. However, no more than 34 days can elapse without an on-site study visit occurring	V20 \| V21 \| V22 \| V23 \| V24 (+4)
xannot-044 44	T3:t7	1	V16 procedures may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance and all scheduled activities are completed prior to dosing	V16
xannot-045 45	T3:c17, T4:c8	2	Perform only for women of childbearing potential and women with a history of tubal ligation. At dosing visits which have pregnancy testing, the pregnancy test result must be confirmed to be negative prior to dosing. Pregnancy testing may be performed more frequently than designated on the SoA if local laws or regulations require more frequent testing.	Urine pregnancy (local)
xannot-046 46	T4:t1	1	V802 is only for randomized participants who were positive for anti-HBc at screening. All other participants will have their final visit at V801 or ETV.	V802
xannot-047 47	T4:t2	1	V997: Additional study procedures can be performed at the discretion of the investigator.	V997
xannot-048 48	T4:c1	1	The intervals between ETV and the post-treatment follow-up visit(s) should be adequate to ensure that V801 occurs at least 8 weeks since last dose and V802 (if applicable) occurs at least 16 weeks since last dose.	V801 \| V802
xannot-049 49	T4:c2	1	No fasting in this period	Fasting visit
xannot-050 50	T4:c7	1	Fasting is not required for the lipid panel at ETV.	Lipid panel 1 cells
xannot-051 51	T4:c12	1	Recommended at ETV based on judgment of the investigator and after discussion with the sponsor’s medical monitor. If not performed at ETV, this will not be considered a protocol deviation.	Endoscopy 1 cells
xannot-052 52	T4:c13	1	Recommended at ETV based on judgment of the investigator and after discussion with the sponsor’s medical monitor.	Colon biopsy sample collection 1 cells
xannot-053 53	T4:c14	1	No dosing at ETV, V997, or post-treatment follow-up visits.	Dosing
xannot-054 54	T4:c15	1	V997: Vital signs collection is optional.	Vital signs 1 cells
xannot-055 55	T4:c16	1	Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed.	Colon biopsy sample collection
xannot-056 56	T4:c17	1	If not performed at ETV, this will not be considered a protocol deviation.	Colon biopsy sample collection 1 cells

Source Note (4)

xannot_id	markers	#	text	scope	points to
xannot-002 2	T1-3:t2	3	For procedures at an ETV, see ETV in Table 4.	table	Table 4 (T4)
xannot-003 3	T1:t3, T2-3:t4	3	For procedures at an unscheduled visit, see V997 in Table 4.	table	Table 4 (T4)
xannot-012 12	T1-3:c9, T4:c5	4	See Section 8.2.2.	Symptom-directed physical examination, including assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes	Section 8.2.2
xannot-034 34	T2:t3	1	For procedures at an early termination visit, see ETV in Table 4.	table	Table 4 (T4)

NCT04677179 — consolidated Schedule of Activities