NCT04730349 · 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

▼ Main Schedule (11 columns)

Activity

Table 1

Table 2

Table 3

Visit
[visit] L1

Screening Visit¹⁸

Cycle 1 Only Cycle = 3 wks^18,37

Cycle 1 Only Cycle = 3 wks^18,37,39

Cycle 1 Only Cycle = 3 wks^18,37

Cycle 2 and Beyond Each cycle = 3 wks^18,37,38

Safety Follow-up Visit 1⁵³

Safety Follow-up Visit 2⁵³

Safety Follow-up Visit 3⁵³

Survival Follow-up Every 3 Months (± 14 Days)⁵⁴

Day
[study_day] L2

Day 1

Day 3 (± 1 day)

Day 5 (± 1 day)

Day 8 (- 1 day)

Day 1

Day 3-5

Eligibility Assessments

Informed Consent¹

Inclusion/Exclusion Criteria²

Medical History³

Safety Assessments

T1,T2,T3

Physical Examination⁴

Performance Status^5,42

T1,T3

Prior and Concomitant Medication Use⁶

Serious Adverse Events (SAE) Assessment^7,21,44

T1,T2,T3

Continuously

See Notes

Targeted Physical Examination, Vital Signs, and Performance Status¹⁹

X³⁶

12-lead Electrocardiogram (ECG)²⁰

X (Cycle 5 only)

Concomitant Medication Use²²

Continuously

Vital Signs⁴¹

12-lead ECG⁴³

Subsequent Medications

Review of Subsequent Anti-cancer Therapy⁴⁵

Laboratory Tests

T1,T2,T3

Clinical Laboratory Testing^8,23

T1,T2

Electrocardiogram⁹

Echocardiogram or Multigated Acquisition Scan (MUGA)¹⁰

Pregnancy Test^11,24,47

T1,T2,T3

Laboratory Tests (includes blood and urine samples)⁴⁶

If toxicities are present.

If toxicities are present

Tumor Assessment

Body Imaging^12,25,48

T1,T2,T3

• Imaging should occur every 9 weeks (± 7 days) from start of treatment for the first 54 weeks, then every 12 weeks (± 7 days) until disease progression or treatment discontinuation (including treatment beyond progression), whichever occurs later. Tumor assessment schedule should be maintained regardless of dose delays. Use same imaging method as was used at screening. • Not applicable to participants with leukemia. • Skull base to mid-thigh [18F]fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) or PET-magnetic resonance imaging (PET-MRI); additional anatomy to include all sites of disease) for FDG-avid non-Hodgkin lymphoma. • Contrast-enhanced CT of the chest, contrast-enhanced CT/magnetic resonance imaging (MRI) of the abdomen, pelvis, and all other known and/or suspected sites of disease. • Participants with metaiodobenzylguanidine (MIBG)-avid neuroblastoma must also undergo MIBG scintigraphy in addition to CT/MRI as above.

• Imaging should occur every 9 weeks (± 7 days) from start of treatment for the first 54 weeks, then every 12 weeks (± 7 days) until disease progression (including treatment beyond progression) or end of study, whichever occurs later. Use same imaging method as was used at screening. After completion of study therapy for participants without progression, results of additional imaging (including bone marrow and CSF, if applicable) are requested for the duration of the study. • Not applicable to participants with leukemia. • Skull base to mid-thigh [18F]fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) or PET-magnetic resonance imaging (PET-MRI); additional anatomy to include all sites of disease for FDG-avid non-Hodgkin lymphoma. • Contrast-enhanced CT of the chest, contrast-enhanced CT/magnetic resonance imaging (MRI) of the abdomen, pelvis, and all other known and/or suspected sites of disease. • Participants with metaiodobenzylguanidine (MIBG)-avid neuroblastoma must also undergo MIBG scintigraphy in addition to CT/MRI as above.

Brain Imaging^13,26,49

T1,T2,T3

• Participants in brain tumor-related cohorts and those with a history of brain metastasis or symptoms should undergo MRI of the brain without and with contrast every 9 weeks (± 7 days) from start of treatment up to 54 weeks, and then approximately every 12 weeks (± 7 days), or sooner if clinically indicated. Tumor assessment schedule should be maintained regardless of dose delays. Cerebrospinal fluid (CSF), if clinically indicated, should be followed as per Response Assessment in Pediatric Neuro-Oncology guidelines.

• Participants in brain tumor-related cohorts and those with a history of brain metastasis or symptoms should undergo MRI of the brain without and with contrast every 9 weeks (± 7 days) from start of treatment up to 54 weeks, and then approximately every 12 weeks (± 7 days), or sooner if clinically indicated until disease progression (including treatment beyond progression) or end of study, whichever occurs later. Cerebrospinal fluid (CSF), if clinically indicated, should be followed as per Response Assessment in Pediatric Neuro-Oncology guidelines.

Cerebrospinal Fluid (CSF) - Solid Tumors¹⁴

Bone Marrow and Buccal Swab - Solid Tumors¹⁵

CSF - Leukemia^16,29

T1,T2

Performed as clinically indicated.

Bone Marrow and Buccal Swab - Leukemia¹⁷

Efficacy Assessments

T2,T3

CSF - Solid tumors²⁷

Performed at time of imaging assessments for disease response as clinically indicated.

Bone Marrow- Solid tumors²⁸

Performed at time of imaging assessments for disease response as clinically indicated.

Bone Marrow - Leukemia³⁰

Performed as clinically indicated.

CSF - solid tumors and leukemia⁵⁰

As clinically indicated.

Bone marrow aspirate - solid tumors and leukemia⁵¹

As clinically indicated

Survival Status⁵²

Pharmacokinetic (PK)/Immunogenicity Assessments⁴⁰

T2,T3

Bempegaldesleukin PK Plasma Samples

See Section 9.5.1 for further details.

Nivolumab PK Serum Samples

See Section 9.5.1 for further details.

Immunogenicity Samples

T2,T3

See Section 9.5.1 for further details.

Health Outcomes

Patient-reported Outcomes (PRO) Version of the CTCAE³¹

See Notes

Study Drug

Determine Dosing Schema³²

Administer Intravenous Fluids³³

Administer Bempegaldesleukin + Nivolumab (Parts A and B)

Review Hydration Guidelines with Participants³⁴

Oral Hydration Follow-up³⁵

X (Day 3-5)

PK Samples

See Section 9.5.1 for further details.

▼ Matches across tables 2 open of 7

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 NCT04730349_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.

state	row	consolidation	other row	activity	decision
open	T2 act-004 Adverse Events Assessment (including Serious Adverse Events)	merged with 0.90	T1 act-009 Serious Adverse Events (SAE) Assessment	xact-009
open	T3 act-005 Adverse Events and Serious Adverse Events (SAE) Assessment	merged with 0.92	T1 act-009 Serious Adverse Events (SAE) Assessment	xact-009
decided · ccorr-001 keep	T2 act-002 Targeted Physical Examination, Vital Signs, and Performance Status	kept separate from 0.70	T1 act-007 Performance Status	xact-022	Table 2 is a combined row: physical examination, vital signs and performance status. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-002 keep	T2 act-005 Concomitant Medication Use	kept separate from 0.84	T1 act-008 Prior and Concomitant Medication Use	xact-024	Table 1 includes prior medication. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-003 keep	T3 act-014 CSF - solid tumors and leukemia	kept separate from 0.84	T2 act-012 CSF - Solid tumors	xact-046	Other population: Table 3 adds leukemia. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-004 keep	T3 act-015 Bone marrow aspirate - solid tumors and leukemia	kept separate from 0.83	T2 act-013 Bone Marrow- Solid tumors	xact-047	Other population: Table 3 adds leukemia. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-005 keep	T3 act-017 Pharmacokinetics (PK)/Immunogenicity Assessment	merged with 1.00	T2 act-016 Pharmacokinetic (PK)/Immunogenicity Assessments	xact-029	Plural only; both are section headers. Kerstin Forsberg, 2026-10-04T08:20:00Z

Draft — entries to append to consolidated/NCT04730349_consolidation_corrections.json; replace each <why>, then re-run consolidation.

▼ Consolidation Metadata Process information

consolidated_at	2026-10-04T08:21:23.000425+00:00
source_activity_count	67
unified_activity_count	49
compression_percent	27
match_stats	exact: 15, fuzzy_auto: 3, new: 49

▼ Source Tables 3 tables

table	type	title / purpose	acts	cols	props
T1	main_soa	Table 2-1: Screening Procedural Outline (CA045020) Screening procedures (single screening visit)	21	1	1
T2	main_soa	Table 2-2: On-treatment Procedural Outline (CA045020) On-treatment schedule (Cycle 1 days and Cycle 2 and beyond)	27	6	2
T3	main_soa	Table 2-3: Long-term Follow-up Period (CA045020) Safety follow-up visits 1-3 and survival follow-up	19	4	1

▼ Property Hierarchy Comparison 3 main timeline tables, 2 levels max

Compares main timeline tables only (main_soa, continuation, subsidiary). Track, domain, and reference tables excluded — different structure by design.

Level	T1	T2	T3	Conclusion
L1	Visit [visit] Single header row. The only schedule column is labelled 'Screening Visit' (footnote a). Typed 'visit' because the label names a visit. The label column holds 'Procedure' (the activity-column heading), so the property name is synthesised.	Cycle [cycle] Top header band: 'Cycle 1 Only (a,b) / Cycle = 3 wks' merged over columns 2-5 and 'Cycle 2 and Beyond (a,b,c) / Each cycle = 3 wks' merged over columns 6-7. Typed 'cycle' because the bands name treatment cycles; the cycle-length line printed in the same cell is kept in the cell value. Label cell is the merged 'Procedure' heading, so the name is synthesised.	Visit [visit] Single header row naming the follow-up visits: Safety Follow-up Visit 1/2/3 (footnote a each) and 'Survival Follow-up Every 3 Months (± 14 Days)' (footnote b). Typed 'visit' because the labels name visits; the survival window is kept in the cell value. Label cell is 'Procedure' (activity-column heading), so the name is synthesised.	≠ Differs
L2	—	Day [study_day] Second header row: day within the cycle (Day 1, Day 3, Day 5, Day 8 for Cycle 1; Day 1, Day 3-5 for Cycle 2 and beyond), with the visit window printed on a second line in the same cell (± 1 day, - 1 day). Typed 'study_day' because the values are cycle days; windows kept in the cell value. Label cell is the merged 'Procedure' heading, so the name is synthesised.	—	1/3 tables

▼ Unified Activities 49 activities

xact_id	activity_name (variations)	parent	match	#	tables	row kind
xact-001	Eligibility Assessments		one table	1	T1	section
xact-002	Informed Consent	Eligibility Assessments	one table	1	T1
xact-003	Inclusion/Exclusion Criteria	Eligibility Assessments	one table	1	T1
xact-004	Medical History	Eligibility Assessments	one table	1	T1
xact-005	Safety Assessments		same name	3	T1, T2, T3	section
xact-006	Physical Examination	Safety Assessments	one table	1	T1
xact-007	Performance Status	Safety Assessments	same name	2	T1, T3
xact-008	Prior and Concomitant Medication Use	Safety Assessments	one table	1	T1
xact-009	Serious Adverse Events (SAE) Assessment ≈ Adverse Events Assessment (including Serious Adverse Events); Adverse Events and Serious Adverse Events (SAE) Assessment	Safety Assessments	near match, accepted	3	T1, T2, T3
xact-022	Targeted Physical Examination, Vital Signs, and Performance Status	Safety Assessments	one table	1	T2
xact-023	12-lead Electrocardiogram (ECG)	Safety Assessments	one table	1	T2
xact-024	Concomitant Medication Use	Safety Assessments	one table	1	T2
xact-041	Vital Signs	Safety Assessments	one table	1	T3
xact-042	12-lead ECG	Safety Assessments	one table	1	T3
xact-043	Subsequent Medications	Safety Assessments	one table	1	T3
xact-044	Review of Subsequent Anti-cancer Therapy	Safety Assessments	one table	1	T3
xact-010	Laboratory Tests		same name	3	T1, T2, T3	section
xact-011	Clinical Laboratory Testing	Laboratory Tests	same name	2	T1, T2
xact-012	Electrocardiogram	Laboratory Tests	one table	1	T1
xact-013	Echocardiogram or Multigated Acquisition Scan (MUGA)	Laboratory Tests	one table	1	T1
xact-014	Pregnancy Test	Laboratory Tests	same name	3	T1, T2, T3
xact-045	Laboratory Tests (includes blood and urine samples)	Laboratory Tests	one table	1	T3
xact-015	Tumor Assessment		one table	1	T1	section
xact-016	Body Imaging	Tumor Assessment	same name	3	T1, T2, T3
xact-017	Brain Imaging	Tumor Assessment	same name	3	T1, T2, T3
xact-018	Cerebrospinal Fluid (CSF) - Solid Tumors	Tumor Assessment	one table	1	T1
xact-019	Bone Marrow and Buccal Swab - Solid Tumors	Tumor Assessment	one table	1	T1
xact-020	CSF - Leukemia	Tumor Assessment	same name	2	T1, T2
xact-021	Bone Marrow and Buccal Swab - Leukemia	Tumor Assessment	one table	1	T1
xact-025	Efficacy Assessments		same name	2	T2, T3	section
xact-026	CSF - Solid tumors	Efficacy Assessments	one table	1	T2
xact-027	Bone Marrow- Solid tumors	Efficacy Assessments	one table	1	T2
xact-028	Bone Marrow - Leukemia	Efficacy Assessments	one table	1	T2
xact-046	CSF - solid tumors and leukemia	Efficacy Assessments	one table	1	T3
xact-047	Bone marrow aspirate - solid tumors and leukemia	Efficacy Assessments	one table	1	T3
xact-048	Survival Status	Efficacy Assessments	one table	1	T3
xact-029	Pharmacokinetic (PK)/Immunogenicity Assessments ≈ Pharmacokinetics (PK)/Immunogenicity Assessment		near match, accepted	2	T2, T3	section
xact-030	Bempegaldesleukin PK Plasma Samples	Pharmacokinetic (PK)/Immunogenicity Asse	one table	1	T2
xact-031	Nivolumab PK Serum Samples	Pharmacokinetic (PK)/Immunogenicity Asse	one table	1	T2
xact-032	Immunogenicity Samples	Pharmacokinetic (PK)/Immunogenicity Asse	same name	2	T2, T3
xact-033	Health Outcomes		one table	1	T2	section
xact-034	Patient-reported Outcomes (PRO) Version of the CTCAE	Health Outcomes	one table	1	T2
xact-035	Study Drug		one table	1	T2	section
xact-036	Determine Dosing Schema	Study Drug	one table	1	T2
xact-037	Administer Intravenous Fluids	Study Drug	one table	1	T2
xact-038	Administer Bempegaldesleukin + Nivolumab (Parts A and B)	Study Drug	one table	1	T2
xact-039	Review Hydration Guidelines with Participants	Study Drug	one table	1	T2
xact-040	Oral Hydration Follow-up	Study Drug	one table	1	T2
xact-049	PK Samples	Pharmacokinetics (PK)/Immunogenicity Ass	one table	1	T3

▼ Unified Annotations 54 annotations (4% dedup from 56)

Footnote (50)

xannot_id	markers	#	text	scope	points to
xannot-001 1	T1:n1	1	Register in Interactive Response Technology (IRT) system to obtain participant number. The participant or legally authorized representative should sign the informed consent prior to any study-related assessment is performed. Study allows for re-enrollment of a participant that is a pre-treatment failure and was not previously treated. If re-enrolled, the participant must be re-consented and assigned a new participant number from IRT.	Informed Consent
xannot-002 2	T1:n2	1	Must be confirmed prior to treatment. See Sections 6.1 and 6.2.	Inclusion/Exclusion Criteria	Section 6.1 · Section 6.2
xannot-003 3	T1:n3	1	All relevant medical history including smoking history, and prior anti-cancer therapies.	Medical History
xannot-004 4	T1:n4	1	Include vital signs (blood pressure, heart rate, and temperature) plus height, weight, and pulse oximetry within 14 days prior to treatment.	Physical Examination
xannot-005 5	T1:n5	1	Within 14 days prior to treatment, collect Lansky play score for ≤ 16 years or Karnofsky performance score for > 16 years of age (Appendix 7).	Performance Status	Appendix 7
xannot-006 6	T1:n6	1	Must be collected within 14 days prior to treatment. Vaccine use within 30 days prior to treatment must be collected.	Prior and Concomitant Medication Use
xannot-007 7	T1:n7	1	SAEs collected and reported from time of consent. All AEs (SAEs or non-serious AEs) related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection collected from time of consent.	Serious Adverse Events (SAE) Assessment
xannot-008 8	T1:n8	1	All laboratory assessments to be performed within 14 days prior to treatment, except for viral testing, which, if clinically indicated, is to be completed within 28 days prior to treatment (see Section 9.4.6 for a list of laboratory tests to conduct).	Clinical Laboratory Testing	Section 9.4.6
xannot-009 9	T1:n9	1	Within 14 days prior to treatment (see Section 9.4.3).	Electrocardiogram	Section 9.4.3
xannot-010 10	T1:n10	1	Left ventricular ejection fraction > 45% within 60 days is required prior to treatment assignment. The investigator should further evaluate participants with other significant abnormalities on echocardiogram/MUGA. Decision regarding treatment should be based on investigator’s best clinical judgment.	Echocardiogram or Multigated Acquisition Scan (MUGA)
xannot-011 11	T1:n11	1	Women of childbearing potential only. Serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) to be done at screening visit and within 24 hours of first dose of study therapy.	Pregnancy Test
xannot-012 12	T1:n12	1	• Imaging to be performed within 28 days prior to treatment. See Section 9.1.1 for further details. • Not applicable to participants with leukemia. • Skull base to mid-thigh [18F]fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) or PET-magnetic resonance imaging (PET-MRI); additional anatomy to include all sites of disease) for FDG-avid non-Hodgkin lymphoma. • Contrast-enhanced CT of the chest, contrast-enhanced CT/magnetic resonance imaging (MRI) of the abdomen, pelvis, and all other known and/or suspected sites of disease. • Participants with metaiodobenzylguanidine (MIBG)-avid neuroblastoma must also undergo MIBG scintigraphy in addition to CT/MRI as above.	Body Imaging	Section 9.1.1
xannot-013 13	T1:n13	1	MRI of the brain without and with contrast is required for participants at baseline in participants with a history of brain metastasis or symptoms. Except for glioma, medulloblastoma, ependymoma, and other central nervous system tumors in which an MRI is required, CT of the brain (without and with contrast) can be performed if MRI is contraindicated. Brain imaging must be done within 28 days prior to treatment. See Section 9.1.1 for further details.	Brain Imaging	Section 9.1.1
xannot-014 14	T1:n14	1	CSF cytopathology should be obtained in any participant with a suspicion or high likelihood of CSF dissemination up to 7 days prior to treatment. This sample can be used as the Cycle 1 Day 1 sample. If initially positive, CSF cytopathology should be followed as part of response assessment. See Section 9.1. [remainder redacted in source]	Cerebrospinal Fluid (CSF) - Solid Tumors	Section 9.1
xannot-015 15	T1:n15	1	For participants with suspected bone marrow disease, bone marrow aspirate obtained where clinically indicated should be submitted along with buccal swab up to 28 days prior to treatment. If initially positive, bone marrow should be evaluated as part of response assessment. See Section 9.1. [remainder redacted in source]	Bone Marrow and Buccal Swab - Solid Tumors	Section 9.1
xannot-016 16	T1:n16	1	Screening sample collected up to 7 days prior to treatment initiation can be used as Cycle 1 Day 1 pretreatment sample. See Section 9.1.2.5. [remainder redacted in source]	CSF - Leukemia	Section 9.1.2.5
xannot-017 17	T1:n17	1	Bone marrow aspirate collected at screening and submitted along with buccal swab up to 28 days prior to treatment initiation can be used as Cycle 1 Day 1 pre-treatment sample. See Section 9.1.2.5. [remainder redacted in source]	Bone Marrow and Buccal Swab - Leukemia	Section 9.1.2.5
xannot-018 18	T1-2:a, T3:c	3	Some of the assessments referred to in this section may not be captured as data in the electronic case report form. They are intended to be used as safety monitoring by the treating physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations.	Screening Visit \| Cycle 1 Only Cycle = 3 wks \| Cycle 1 Only Cycle = 3 wks \| Cycle 1 Only Cycle = 3 wks \| Cycle 1 Only Cycle = 3 wks (+2)
xannot-019 19	T2:n1	1	Vital signs (blood pressure, heart rate, and temperature), weight, Lansky play score for ≤ 16 years or Karnofsky performance score for > 16 years of age (Appendix 7). Monitor and record vital signs at predose and within 30 minutes after administration of nivolumab.	Targeted Physical Examination, Vital Signs, and Performance Status	Appendix 7
xannot-020 20	T2:n2	1	Pre-dose Day 1 of all cycles Pre-PK blood draw on Cycle 1, Days 3,5, and 8 Pre-PK blood draw on Cycle 5, Days 3 and 5 ECG should be performed within 30 minutes prior to PK blood draw. Participant should rest for 5 minutes prior to each ECG	12-lead Electrocardiogram (ECG)
xannot-021 21	T2:n3	1	Adverse events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 5. Record at each visit. All AEs (SAEs or non-serious AEs), including those associated with SARS-CoV-2 infection, must be collected continuously throughout the treatment period and for a minimum of 150 days after last dose of study treatment (Appendix 3).	Serious Adverse Events (SAE) Assessment	Appendix 3
xannot-022 22	T2:n4	1	Record at each visit.	Concomitant Medication Use
xannot-023 23	T2:n5	1	Hematology and chemistry assessments scheduled for the day of study drugs dosing must be available and assessed before dosing. Hematology and chemistry assessments can be drawn within 72 hours prior to treatment, though renal function (ie, serum creatinine) must be assessed within 24 hours prior to dosing with bempegaldesleukin or as soon as locally feasible. Refer to Section 9.4.6 for a list of laboratory tests to conduct.	Clinical Laboratory Testing	Section 9.4.6
xannot-024 24	T2:n6	1	Serum or urine pregnancy test (minimum sensitivity units 25 IU/L or equivalent units of human chorionic gonadotropin) is required within 24 hours prior to treatment in women of childbearing potential.	Pregnancy Test
xannot-025 25	T2:n7	1	All study treatment decisions will be based on the investigator’s assessment of tumor images. See Section 9.1.1 for additional details and to Section 8.1.2 for tumor assessment associated with treatment beyond progression.	Body Imaging	Section 9.1.1 · Section 8.1.2
xannot-026 26	T2:n8	1	Except for glioma, medulloblastoma, ependymoma and other central nervous system tumors in which an MRI is required, CT of the brain (without and with contrast) can be performed if MRI is contraindicated. See Section 9.1.1 for further details.	Brain Imaging	Section 9.1.1
xannot-027 27	T2:n9	1	CSF cytopathology should be obtained in any participant with a previously positive CSF as part of response assessment (see Section 9.1). [remainder redacted in source]	CSF - Solid tumors	Section 9.1
xannot-028 28	T2:n10	1	Bone marrow biopsy/aspirate should be obtained in any participant with a previously positive bone marrow aspirate as part of response assessment (see Section 9.1). [remainder redacted in source]	Bone Marrow- Solid tumors	Section 9.1
xannot-029 29	T2:n11	1	CSF cytopathology should be obtained in any participant with a previously positive CSF as part of response assessment (see Section 9.1.2.5). [remainder redacted in source]	CSF - Leukemia	Section 9.1.2.5
xannot-030 30	T2:n12	1	Bone marrow biopsy/aspirate should be obtained in any participant with a previously positive bone marrow aspirate as part of response assessment. [remainder redacted in source]	Bone Marrow - Leukemia
xannot-031 31	T2:n13	1	Questionnaire to be administered electronically in Part B only, on a weekly basis during the first 3 cycles of treatment, every cycle from Cycles 4 through 8, and then every other cycle (starting at Cycle 10) while on treatment until end of treatment. PRO-CTCAE™ for adults ≥18 years. Pediatric (Ped-PRO-CTCAE) for children ≥7 to <18 years. Ped-PRO-CTCAE [Caregiver] for children <7 years.	Patient-reported Outcomes (PRO) Version of the CTCAE
xannot-033 33	T2:n15	1	May be withheld if deemed by the investigator to be in the best interest of the participant. Refer to Section 7.1.1.1 for additional information.	Administer Intravenous Fluids	Section 7.1.1.1
xannot-035 35	T2:n17	1	For the first 2 doses of bempegaldesleukin, between Days 3 and 5 following infusion, site personnel must contact the participant (by telephone or clinic visit) to remind the participant of the oral hydration guidelines, to assess for any symptomatology and compliance with the guidelines, and document the results of the discussion. For subsequent administrations of bempegaldesleukin, the oral hydration follow-up should be conducted as clinically indicated for participants receiving bempegaldesleukin. See Section 7.1.1.1 for details.	Oral Hydration Follow-up	Section 7.1.1.1
xannot-036 36	T2:*	1	At Day 8 visits collect vital signs only.	Targeted Physical Examination, Vital Signs, and Performance Status 1 cells
xannot-037 37	T2:b	1	If a dose is delayed, the procedures scheduled for that same time point, with the exception of the body/brain imaging, should also be delayed to coincide with when the time point’s dosing actually occurs.	Cycle 1 Only Cycle = 3 wks \| Cycle 1 Only Cycle = 3 wks \| Cycle 1 Only Cycle = 3 wks \| Cycle 1 Only Cycle = 3 wks \| Cycle 2 and Beyond Each cycle = 3 wks (+1)
xannot-038 38	T2:c	1	For Cycle 5 only, participants will return for additional sample collection at Days 3 and 5. Refer to Section 9.5.1 (Table 9.5.1-1) for all details, including allowed windows.	Cycle 2 and Beyond Each cycle = 3 wks \| Cycle 2 and Beyond Each cycle = 3 wks	Section 9.5.1 · Table 9.5.1-1
xannot-039 39	T2:d	1	Samples can be collected ± 3 hours. If participants are dosed on a Thursday, Day 3 samples may be collected on Day 2. If dosed on a Friday, Day 3 sample can be collected on Day 4.	Cycle 1 Only Cycle = 3 wks
xannot-040 40	T2:e	1	For participants who require blood draw volume modifications, blood collection volumes will be reduced per guidelines outlined in the laboratory manual. Omitted blood collection will likely be for [redacted in source] pharmacokinetic assessments, since all required safety assessments must be performed.	Pharmacokinetic (PK)/Immunogenicity Assessments
xannot-041 41	T3:n1	1	Blood pressure, heart rate, temperature.	Vital Signs
xannot-042 42	T3:n2	1	Lansky play score for ≤ 16 years or Karnofsky performance score for > 16 years of age (Appendix 7).	Performance Status	Appendix 7
xannot-043 43	T3:n3	1	Participant should rest for 5 minutes prior to each ECG.	12-lead ECG
xannot-044 44	T3:n4	1	All SAEs and non-serious AEs should be collected continuously during the treatment period and for a minimum of 150 days following discontinuation of study treatment. Participants will be followed for all SAEs, non-serious AEs of special interest (as defined in Section 9.2.8) and all AEs (SAEs and non-serious AEs) associated with confirmed or suspected SARS-CoV-2 infection until resolution, the condition stabilizes, the event is otherwise explained, the event is deemed irreversible, the participant is lost to follow-up (as defined in Section 8.3), or for suspected cases, until SARS-CoV-2 infection is ruled-out.	Serious Adverse Events (SAE) Assessment	Section 9.2.8 · Section 8.3
xannot-045 45	T3:n5	1	Additional subsequent cancer therapy details such as regimen, setting of the regimen, line of therapy, start and end date of each regimen, best response to the regimen, and date of progression to subsequent anti-cancer therapies will be collected.	Review of Subsequent Anti-cancer Therapy
xannot-047 47	T3:n7	1	Women of childbearing potential only. Serum or urine pregnancy test (minimum sensitivity equivalent units 25 IU/L or equivalent units of human chorionic gonadotropin) is required.	Pregnancy Test
xannot-049 49	T3:n9	1	Except for glioma, medulloblastoma, ependymoma, and other central nervous system tumors in which an MRI is required, CT of the brain without and with contrast can be performed if MRI is contraindicated. See Section 9.1.1 for further details.	Brain Imaging	Section 9.1.1
xannot-050 50	T3:n10	1	CSF cytopathology should be obtained in any participant with a previously positive CSF as part of response assessment. See Section 9.1	CSF - solid tumors and leukemia	Section 9.1
xannot-051 51	T3:n11	1	Bone marrow aspirate should be obtained in any participant with a previously positive bone marrow aspirate as part of response assessment. See Section 9.1.	Bone marrow aspirate - solid tumors and leukemia	Section 9.1
xannot-052 52	T3:n12	1	During safety follow-up and every 3 months (clinic visit or by telephone) thereafter and during survival phase. Include documentation of subsequent chemotherapy. See Section 5.1.4.	Survival Status	Section 5.1.4
xannot-053 53	T3:a	1	Participants must be followed for at least 150 days after last dose of study treatment. Follow-up Visit 1 should occur 30 days from the last dose (± 7) days or can be performed on the date of discontinuation if that date is greater than 42 days from last dose. Follow-up Visit 2 occurs approximately 100 days (± 7 days) from last dose of study drug. Follow-up Visit 3 occurs approximately 150 days (± 7 days) from last dose of study drug. All 3 follow-up visits should be conducted in person.	Safety Follow-up Visit 1 \| Safety Follow-up Visit 2 \| Safety Follow-up Visit 3
xannot-054 54	T3:b	1	Survival follow-up visits to occur every 3 months subsequent to Follow-up Visit 3. Survival visits may be conducted in person or by telephone. Bristol-Myers Squibb may request that survival data be collected on all treated participants outside of the 3 month specified window. At the time of this request, each participant will be contacted to determine their survival status unless the participant has withdrawn consent for all contact.	Survival Follow-up Every 3 Months (± 14 Days)

Source Note (4)

xannot_id	markers	#	text	scope	points to
xannot-032 32	T2:n14	1	See Figure 5.1-1, Figure 5.1-2 and Figure 5.1-3.	Determine Dosing Schema	Figure 5.1-1 · Figure 5.1-2 · Figure 5.1-3
xannot-034 34	T2:n16	1	See Section 7.1.1.1.	Review Hydration Guidelines with Participants	Section 7.1.1.1
xannot-046 46	T3:n6	1	See Section 9.4.6 for the list of laboratory tests.	Laboratory Tests (includes blood and urine samples)	Section 9.4.6
xannot-048 48	T3:n8	1	See Section 9.1.1 for further details.	Body Imaging	Section 9.1.1

NCT04730349 — consolidated Schedule of Activities