NCT04557384 · 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

Continued Access only

▼ Main Schedule (15 columns)

Activity	In	Table 1
Epoch [epoch] L1		Screening	Screening	On-Treatment	On-Treatment	On-Treatment	On-Treatment	On-Treatment	On-Treatment	On-Treatment³	On-Treatment²	On-Treatment	On-Treatment	On-Treatment	On-Treatment³	Post-Treatment¹
Cycle length [other] L2				Cycle = 21 days	Cycle = 21 days	Cycle = 21 days	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)	Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)
Cycle [cycle] L3		(Day Relative to C1D1)	(Day Relative to C1D1)	Cycle 1	Cycle 1	Cycle 1	Cycle 2	Cycle 2	Cycle 2	Cycle 2	Cycle 2-n (If combo therapy is held and ramucirumab is given)	Cycle 3-n	Cycle 3-n	Cycle 3-n	Cycle 3-n	Short-term follow-up
Day [study_day] L4		≤28	≤7	D1	D8	D15	D1	D8	D15	D22	DX	D1	D8	D15	D22	V801
Visit window [window]				(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)	(±3 days)
Informed consent⁴	T1	X
Inclusion/Exclusion criteria	T1	X
Medical history⁵	T1	X
Cancer treatment history⁶	T1	X
Concomitant medication⁷	T1	X		X	X	X	X	X	X	X	X	X	X	X	X
Physical examination	T1	X		X	X	X	X					X				X
Vital signs⁸	T1	X		See instructions	See instructions	See instructions	X	X	X	X	X	X	X	X	X	X
AE collection^9,25	T1,T2	X		X	X	X	X	X	X	X	X	X	X	X	X	X
ECOG PS¹⁰	T1	X		X			X					X				X
ECG¹¹	T1	X		See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	X
Hematology¹²	T1		X	X	X	X	X	X	X		X	X				X
Coagulation¹³	T1		X				X
Clinical chemistry¹²	T1		X	X	X	X	X	X	X		X	X				X
Urinalysis¹⁴	T1		X	X	X	X	X	X	X	X	X	X	X	X	X	X
Pregnancy test¹⁵	T1		X	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	X
Thyroid panel¹⁶	T1		X	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	X
Radiologic imaging and measurement of palpable or visible lesions¹⁷	T1	X		See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	X
Injection site assessments (solicited)¹⁸	T1			See instructions	See instructions	See instructions	X	X	X	X	X	X	X	X	X
Injection site assessments (spontaneous)¹⁹	T1			See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions
Participant diary²⁰	T1			See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions
Sample collection²¹	T1
PK	T1				See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1
IG	T1				See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1	See Section 1.3.1
Administer ramucirumab^22,27	T1,T2			See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions
Administer combination medications, if applicable (Cohorts B and C only)²³	T1			See instructions	See instructions	See instructions	See instructions	See instructions	See instructions	See instructions		See instructions	See instructions	See instructions	See instructions

Activity

Table 1

Epoch
[epoch] L1

Screening

On-Treatment

On-Treatment³

On-Treatment²

On-Treatment

On-Treatment³

Post-Treatment¹

Cycle length
[other] L2

Cycle = 21 days

Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)

Cycle
[cycle] L3

(Day Relative to C1D1)

Cycle 1

Cycle 2

Cycle 2-n (If combo therapy is held and ramucirumab is given)

Cycle 3-n

Short-term follow-up

Day
[study_day] L4

≤28

≤7

D15

D22

D15

D22

V801

Visit window
[window]

(±3 days)

Informed consent⁴

Inclusion/Exclusion criteria

Medical history⁵

Cancer treatment history⁶

Concomitant medication⁷

Physical examination

Vital signs⁸

See instructions

AE collection^9,25

T1,T2

ECOG PS¹⁰

ECG¹¹

See instructions

Hematology¹²

Coagulation¹³

Clinical chemistry¹²

Urinalysis¹⁴

Pregnancy test¹⁵

See instructions

Thyroid panel¹⁶

See instructions

Radiologic imaging and measurement of palpable or visible lesions¹⁷

See instructions

Injection site assessments (solicited)¹⁸

See instructions

Injection site assessments (spontaneous)¹⁹

See instructions

Participant diary²⁰

See instructions

Sample collection²¹

See Section 1.3.1

Administer ramucirumab^22,27

T1,T2

See instructions

Administer combination medications, if applicable (Cohorts B and C only)²³

See instructions

▼ Track Timelines: Continued Access (2 columns)

Activity	In	Table 2
		Continued Access	Continued Access
Epoch [epoch] L1		Study Treatment	Follow-Up²⁴
Visit [visit] L2		501-5XX	901
AE collection^9,25	T1,T2	X	X
Sample collection²¹	T1
Administer ramucirumab^22,27	T1,T2	X
PK, IG, and exploratory hypersensitivity²⁶	T2

Activity

Table 2

Continued Access

Epoch
[epoch] L1

Study Treatment

Follow-Up²⁴

Visit
[visit] L2

501-5XX

901

AE collection^9,25

T1,T2

Sample collection²¹

Administer ramucirumab^22,27

T1,T2

PK, IG, and exploratory hypersensitivity²⁶

▼ Subsidiary Schedule (5 columns)

Activity	In	Table 3
Column heading [other] L1		Study Cycle	Day within Cycle	Collection Time Point Relative to Ramucirumab Weekly Dose	Ramucirumab PK Collection	Immunogenicity Collection
Sample collection²¹	T1
Sample 1	T3	1	1	-1 hr (predose)	X	X
Sample 2	T3	1	2	24 hrs ± 2 postdose	X
Sample 3	T3	1	4 ± 1	48-96 hrs postdose window	X
Sample 4	T3	1	8	-1 hr (predose)	X
Sample 5	T3	1	15	-1 hr (predose)	X	X
Sample 6	T3	1	18 ± 1	48-96 hrs postdose window	X
Sample 7	T3	2	1	-1 hr (predose)	X
Sample 8	T3	2	8	-1 hr (predose)	X	X
Sample 9	T3	2	11 ± 1	48-96 hrs postdose window	X
Sample 10	T3	3	1	-1 hr (predose)	X
Sample 11	T3	3	15	-1 hr (predose)	X
Sample 12	T3	3	18 ± 1	48-96 hrs postdose window	X
Sample 13	T3	4	1	-1 hr (predose)	X	X
Sample 14	T3	5	1	-1 hr (predose)	X
End of treatment	T3			30 days post last dose	X	X

Activity

Table 3

Column heading
[other] L1

Study Cycle

Day within Cycle

Collection Time Point Relative to Ramucirumab Weekly Dose

Ramucirumab PK Collection

Immunogenicity Collection

Sample collection²¹

Sample 1

-1 hr (predose)

Sample 2

24 hrs ± 2 postdose

Sample 3

4 ± 1

48-96 hrs postdose window

Sample 4

-1 hr (predose)

Sample 5

-1 hr (predose)

Sample 6

18 ± 1

48-96 hrs postdose window

Sample 7

-1 hr (predose)

Sample 8

-1 hr (predose)

Sample 9

11 ± 1

48-96 hrs postdose window

Sample 10

-1 hr (predose)

Sample 11

-1 hr (predose)

Sample 12

18 ± 1

48-96 hrs postdose window

Sample 13

-1 hr (predose)

Sample 14

-1 hr (predose)

End of treatment

30 days post last dose

▼ Matches across tables all 15 decided

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 NCT04557384_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
decided · ccorr-001 keep	T2 act-001 AE Collection	merged with 1.00	T1 act-008 AE collection	xact-008	Case only. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-002 keep	T3 act-001 Sample 1	kept separate from 0.80	T1 act-021 Sample collection	xact-027	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-003 keep	T3 act-002 Sample 2	kept separate from 0.80	T1 act-021 Sample collection	xact-028	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-004 keep	T3 act-003 Sample 3	kept separate from 0.80	T1 act-021 Sample collection	xact-029	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-005 keep	T3 act-004 Sample 4	kept separate from 0.80	T1 act-021 Sample collection	xact-030	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-006 keep	T3 act-005 Sample 5	kept separate from 0.80	T1 act-021 Sample collection	xact-031	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-007 keep	T3 act-006 Sample 6	kept separate from 0.80	T1 act-021 Sample collection	xact-032	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-008 keep	T3 act-007 Sample 7	kept separate from 0.80	T1 act-021 Sample collection	xact-033	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-009 keep	T3 act-008 Sample 8	kept separate from 0.80	T1 act-021 Sample collection	xact-034	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-010 keep	T3 act-009 Sample 9	kept separate from 0.80	T1 act-021 Sample collection	xact-035	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-011 keep	T3 act-010 Sample 10	kept separate from 0.80	T1 act-021 Sample collection	xact-036	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-012 keep	T3 act-011 Sample 11	kept separate from 0.80	T1 act-021 Sample collection	xact-037	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-013 keep	T3 act-012 Sample 12	kept separate from 0.80	T1 act-021 Sample collection	xact-038	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-014 keep	T3 act-013 Sample 13	kept separate from 0.80	T1 act-021 Sample collection	xact-039	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-015 keep	T3 act-014 Sample 14	kept separate from 0.80	T1 act-021 Sample collection	xact-040	A numbered sample row of the PK sampling schedule; the target is a section header. Kerstin Forsberg, 2026-10-04T08:20:00Z

Draft — entries to append to consolidated/NCT04557384_consolidation_corrections.json; replace each <why>, then re-run consolidation.

▼ Consolidation Metadata Process information

consolidated_at	2026-10-04T08:21:21.897485+00:00
source_activity_count	43
unified_activity_count	41
compression_percent	5
match_stats	exact: 1, fuzzy_auto: 1, new: 41

▼ Source Tables 3 tables

table	type	track	title / purpose	acts	cols	props
T1	main_soa		Screening, On-Study, and Post-Treatment Schedule of Activities Main schedule: screening, on-treatment cycles, and short-term follow-up	25	15	5
T2	track	Continued Access	Continued Access Schedule of Activities Schedule for participants in the continued-access period	3	2	2
T3	subsidiary		Pharmacokinetic Sampling Schedule Detailed PK and immunogenicity sample timing (Section 1.3.1) for the 'Sample collection: PK / IG' rows of Table 1	15	5	1

▼ Property Hierarchy Comparison 2 main timeline tables, 4 levels max

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

Level	T1	T3	Conclusion
L1	Epoch [epoch] Study-phase band: 'Screening' (cols 2-3, merged vertically over rows 2-3), 'On-Treatment' (cols 4-15), 'Post-Treatment' (col 16, merged vertically over rows 2-3). Major study phases -> epoch. Label cell empty (label column is one merged blank cell over rows 2-6); name synthesised.	Column heading [other] Single header row naming the columns: 'Study Cycle' (col 2, cycle number), 'Day within Cycle' (col 3, day), 'Collection Time Point Relative to Ramucirumab Weekly Dose' (col 4, timepoint), 'Ramucirumab PK Collection' (col 5) and 'Immunogenicity Collection' (col 6) (sample types marked X). The label cell reads 'Sample #' (heading of the label column); property name synthesised. Mixed content -> other.	≠ Differs
L2	Cycle length [other] Cycle-duration band under On-Treatment: 'Cycle = 21 days' (cols 4-6, Cycle 1) and 'Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)' (cols 7-15, Cycle 2 onward). Groups cycles by duration rule; not itself a visit/cycle identifier, so typed 'other'. Cols 2-3 and 16 are the vertical continuation of the row-2 Screening/Post-Treatment cells (left empty here). Label cell empty; name synthesised.	—	1/2 tables
L3	Cycle [cycle] Cycle identifiers: 'Cycle 1' (cols 4-6), 'Cycle 2' (cols 7-10), 'Cycle 2-n (If combo therapy is held and ramucirumab is given)' (col 11), 'Cycle 3-n' (cols 12-15), 'Short-term follow-up' with footnote a (col 16); screening cols 2-3 carry the qualifier '(Day Relative to C1D1)' (merged vertically over rows 4-5). Treatment cycles -> cycle. Label cell empty; name synthesised.	—	1/2 tables
L4	Day [study_day] Day labels per column: screening days '≤28', '≤7' (relative to C1D1), cycle days D1/D8/D15 (Cycle 1), D1/D8/D15/D22 (Cycle 2), 'DX' (additional ramucirumab dose when combination held), D1/D8/D15/D22 (Cycle 3-n), and visit code 'V801' for short-term follow-up. Predominantly days within cycle -> study_day (V801 is a visit code, noted). Carries the Instructions-column note 'D22 for 28-day cycles only.' (synthesised marker i1). Label cell empty; name synthesised.	—	1/2 tables
Column Qualifiers
—	Visit window [window] Allowed visit windows '(±3 days)' per cycle block (cols 4-6, 7-10, 11, 12-15) and for col 16. Cols 2-3 are the vertical continuation of the row-4 '(Day Relative to C1D1)' cell. Windows -> window; presentational qualifier that does not distinguish columns, hence hierarchical_level null. Label cell empty; name synthesised.	—	1/2 tables

▼ Unified Activities 41 activities

xact_id	activity_name (variations)	parent	match	#	tables	row kind
xact-001	Informed consent		one table	1	T1
xact-002	Inclusion/Exclusion criteria		one table	1	T1
xact-003	Medical history		one table	1	T1
xact-004	Cancer treatment history		one table	1	T1
xact-005	Concomitant medication		one table	1	T1
xact-006	Physical examination		one table	1	T1
xact-007	Vital signs		one table	1	T1
xact-008	AE collection ≈ AE Collection		near match, accepted	2	T1, T2
xact-009	ECOG PS		one table	1	T1
xact-010	ECG		one table	1	T1
xact-011	Hematology		one table	1	T1
xact-012	Coagulation		one table	1	T1
xact-013	Clinical chemistry		one table	1	T1
xact-014	Urinalysis		one table	1	T1
xact-015	Pregnancy test		one table	1	T1
xact-016	Thyroid panel		one table	1	T1
xact-017	Radiologic imaging and measurement of palpable or visible lesions		one table	1	T1
xact-018	Injection site assessments (solicited)		one table	1	T1
xact-019	Injection site assessments (spontaneous)		one table	1	T1
xact-020	Participant diary		one table	1	T1
xact-021	Sample collection		one table	1	T1	section
xact-022	PK	Sample collection	one table	1	T1
xact-023	IG	Sample collection	one table	1	T1
xact-024	Administer ramucirumab		same name	2	T1, T2
xact-025	Administer combination medications, if applicable (Cohorts B and C only)		one table	1	T1
xact-026	PK, IG, and exploratory hypersensitivity		one table	1	T2
xact-027	Sample 1		one table	1	T3
xact-028	Sample 2		one table	1	T3
xact-029	Sample 3		one table	1	T3
xact-030	Sample 4		one table	1	T3
xact-031	Sample 5		one table	1	T3
xact-032	Sample 6		one table	1	T3
xact-033	Sample 7		one table	1	T3
xact-034	Sample 8		one table	1	T3
xact-035	Sample 9		one table	1	T3
xact-036	Sample 10		one table	1	T3
xact-037	Sample 11		one table	1	T3
xact-038	Sample 12		one table	1	T3
xact-039	Sample 13		one table	1	T3
xact-040	Sample 14		one table	1	T3
xact-041	End of treatment		one table	1	T3

▼ Unified Annotations 31 annotations (0% dedup from 31)

Footnote (29)

xannot_id	markers	#	text	scope	points to
xannot-001 1	T1:a	1	Short-term follow-up begins when the participant and investigator agree that the participant will no longer continue study treatment and lasts a minimum of 30 days following the last dose of study drug.	Short-term follow-up
xannot-002 2	T1:n1	1	Note: For applicable participants who have their combination therapy held while SC weekly ramucirumab is continued, procedures noted in column DX are to be performed at the time of the additional ramucirumab doses.	Cycle 2-n (If combo therapy is held and ramucirumab is given)
xannot-003 3	T1:i1	1	D22 for 28-day cycles only.	Cycle 2 \| Cycle 3-n
xannot-004 4	T1:i2	1	ICF must be signed before any protocol-specific procedures are performed	Informed consent
xannot-005 5	T1:i3	1	Including assessment of preexisting conditions, historical illnesses, and habits (such as tobacco and alcohol use).	Medical history
xannot-006 6	T1:i4	1	Record prior anti-cancer therapy	Cancer treatment history
xannot-007 7	T1:i5	1	• At baseline, record prior and concurrent medications. • Record all premedication, supportive care, and concomitant medication continuously at every visit and throughout the study.	Concomitant medication
xannot-008 8	T1:i6	1	Measure vital signs (height [at baseline], weight, temperature, blood pressure, pulse rate, and respiration rate). On days with concurrent ECGs, vital signs, and/or PK sampling, these measurements should occur at approximately the same time. Vital sign measurements will be obtained: • Day 1 at predose (prior to SC ramucirumab dose, but within 90 minutes prior to predose blood draw) • C1D2 (24 hours postdose) • C1D8 • C1D15 • Any time for other specified visits, but prior to SC ramucirumab dose at same visit.	Vital signs
xannot-009 9	T1:i7	1	• Collect continuously at every visit and throughout the study. • CTCAE Version 5.0 • See Section 10.3 for AE grading for lab investigations.	AE collection	Section 10.3
xannot-010 10	T1:i8	1	During study treatment, perform ≤3 days prior to treatment.	ECOG PS
xannot-011 11	T1:i9	1	Single, local. On days with concurrent measurements, see vital sign row for more details. Times are referenced to the end of dosing. ECGs will be obtained: • C1D1 at predose. • Every 6 weeks thereafter, predose. • Any other time as clinically indicated.	ECG
xannot-013 13	T1:i11	1	See Appendix 2. Perform at baseline, C2D1, D1 of every other cycle afterwards (C4D1, C6D1, etc.), and as clinically indicated.	Coagulation	Appendix 2
xannot-014 14	T1:i12	1	See Appendix 2. In addition, perform as clinically indicated.	Urinalysis	Appendix 2
xannot-015 15	T1:i13	1	• Applies only to women of childbearing potential. • Note: During study treatment, perform monthly or as required per local regulations and/or institutional guidelines. See Appendix 2.	Pregnancy test	Appendix 2
xannot-016 16	T1:i14	1	See Appendix 2. Starting C1D1, then every 3 months thereafter.	Thyroid panel	Appendix 2
xannot-017 17	T1:i15	1	• Perform according to RECIST 1.1, by the same method used at baseline, every 8 weeks (±7 days) for the first 6 months after C1D1 and every 12 weeks (±7 days) thereafter until radiographic disease progression, death, or study completion, whichever occurs first. Perform as scheduled, even if study treatment is delayed or omitted.	Radiologic imaging and measurement of palpable or visible lesions
xannot-018 18	T1:i16	1	Prior to each injection and at the designated timepoints, the investigator/investigator designee will ask the participant if they have any injection site concerns and record the participant’s response. 1.Cycle 1 collection: a.C1D1: 5-15 min after injection is complete and 60 min after injection is complete b.C1D2 (approximately 24 hr after injection) c.C1D4 (± 1 day) d.C1D8: 5-15 min after injection and 60 min after injection e.C1D15: 5-15 min after injection and 60 min after injection 2.Cycle 2-n collection: a.5-15 min after injection and 60 min after injection The findings from the assessment are recorded on the ISR questionnaire. All positive responses of pain require an additional assessment using the participant-completed Pain VAS. If there are ≥2 injections, the ISR questionnaire will be filled out separately for each site, after all injections have been administered. See Section 8.2.5 for details.	Injection site assessments (solicited)	Section 8.2.5
xannot-019 19	T1:i17	1	1. ISR questionnaire completed outside of solicited assessment schedule. 2. May be triggered by participant anytime during the cycle based on diary. 3. If the participant indicates presence of pain during spontaneous ISR reporting, no VAS assessment is required.	Injection site assessments (spontaneous)
xannot-020 20	T1:i18	1	• Participant will assess injection site(s) daily. If any ISR symptoms present, the participant should contact the investigator. • Diary should be returned to the investigator at each weekly visit.	Participant diary
xannot-022 22	T1:i20	1	See Section 6.1. Participants must be closely monitored for a 1-hour observation period following the administration of SC ramucirumab (see Section 6.1).	Administer ramucirumab	Section 6.1
xannot-023 23	T1:i21	1	Begin Combination anti-cancer therapies along with weekly SC ramucirumab at Cycle-2. See details in Section 6.1. Erlotinib (1L EGFR+ NSCLC), docetaxel (2L NSCLC), paclitaxel (2L gastric), FOLFIRI (2L CRC).	Administer combination medications, if applicable (Cohorts B and C only)	Section 6.1
xannot-024 24	T2:a	1	Continued-access follow-up begins when the participant and the investigator agree that the participant will no longer continue treatment in the continued-access period and lasts a minimum of 30 days following the last dose of study drug. In all cases, no follow-up procedures will be performed for a participant who withdraws informed consent unless he or she has explicitly provided permission and consent.	901
xannot-025 25	T2:i1	1	Grading via CTCAE, Version 5.0. As part of AE collection, monitor vital signs and perform standard laboratory tests (hematology, chemistry, urinalysis, and pregnancy testing) at the same frequency as during the study treatment period. See Section 10.3 for AE grading for lab investigations. All laboratory tests during the continued access period will be performed in the local laboratories only.	AE collection	Section 10.3
xannot-026 26	T2:i2	1	In the event of hypersensitivity, blood samples will be collected for PK, IG, and exploratory hypersensitivity analyses at the following time points, as close as possible to: (i) the onset of the hypersensitivity, (ii) the resolution of the hypersensitivity, and (iii) 30 (±3) days following the hypersensitivity.	PK, IG, and exploratory hypersensitivity
xannot-027 27	T2:i3	1	See Section 6.1. Participants must be closely monitored for a 1-hour observation period following the ramucirumab injection (see Section 6.1).	Administer ramucirumab	Section 6.1
xannot-028 28	T3:g1	1	The pharmacokinetic sampling table applies to all participants irrespective of 21-day or 28-day cycle length.	table
xannot-029 29	T3:g2	1	Adequately record the actual collection date and time (24-hour clock; for example, 16:00, not 4 pm) on the requisition form of the sample.	table
xannot-030 30	T3:g3	1	In case of cycle delay and/or ramucirumab dosing interruption, if possible, collect an additional unscheduled PK samples using the appropriate central lab collection kit: • at time as close as possible to the onset of the adverse event (AE) (if the cycle delay or ramucirumab dosing interruption is due to an AE). • at the time when ramucirumab dose should have been administered (if there had not been a delay or dose interruption). • prior to resuming the ramucirumab dosing after dosing interruption/dosing delay.	table
xannot-031 31	T3:g4	1	Note: If the above time points for unscheduled PK sampling happen to occur at the same time as a scheduled PK time point (see table below), then only the scheduled sample will be taken.	table

Source Note (2)

xannot_id	markers	#	text	scope	points to
xannot-012 12	T1:i10	1	See Appendix 2.	Hematology \| Clinical chemistry	Appendix 2
xannot-021 21	T1:i19	1	See Section 1.3.1 for PK and IG.	Sample collection	Section 1.3.1

NCT04557384 — consolidated Schedule of Activities