NCT03283098 · 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 (20 columns)

Activity

Table 1

Study Day
[study_day] L1

Screening

-2

1 (HD)

3 (HD)

6 (HD)

8 (HD)

10 (HD)

13 (HD)

15 (HD)

17 (HD)

20 (HD)

22 (HD)

24 (HD)

27 (HD)

29/ET (HD)^1,8

34 (HD)

41 (HD)

55 (HD)

Study Visit (Day)
[other]

Study Visit (Day)

Informed consent

Eligibility

Medical and surgical history

Demographics⁹

Prior medications

Body Height²

Body Weight²

Physical exam²

Hemodialysis symptoms³

Investigational product administration⁴

Vital Signs (BP, HR, RR, TEMP)⁵

12-lead electrocardiogram⁶

Adverse Event Monitoring⁷

Concomitant Medications

Laboratory Assessments

Central Laboratory

▼ Domain Schedule (40 columns)

Activity

Table 2

Table 3

Study Day
[study_day] L1

Screening

-2

1 (HD)

3 (HD)

6 (HD)

8 (HD)

10 (HD)

13 (HD)

15 (HD)

17 (HD)

20 (HD)

22 (HD)

24 (HD)

27 (HD)

29/ET (HD)¹⁰

34 (HD)

41 (HD)

55 (HD)

Screening

-2

1 (HD)

3 (HD)

6 (HD)

8 (HD)

10 (HD)

13 (HD)

15 (HD)

17 (HD)

20 (HD)

22 (HD)

24 (HD)

27 (HD)

29/ET (HD)¹⁸

34 (HD)

41 (HD)

55 (HD)

Study Visit (Day)
[other]

Study Visit (Day)

Laboratory Assessments

Hematology, PT, aPTT^12,17

Clinical Chemistry¹⁷

Albumin^13,17

X¹¹

Phosphorus¹⁷

X¹¹

Calcium (cCa)^13,17

X¹¹

Serum or Urine Pregnancy (females only)¹⁷

X¹¹

Serum FSH (female only)^16,17

Breath Alcohol Screen¹⁷

HIV, Hep C Ab, HBsAg¹⁷

iPTH¹⁷

X¹¹

25(OH) vitamin D¹⁷

Kt/V or URR^14,17

Anti-drug antibodies^15,17

Central Laboratory

PK (Pre HD)

PK (SDA + 10 min)

PK (SDA + 30 min)

PK (SDA + 60 min)

PK (SDA + 90 min)

PK (SDA + 18 to 30 hr)

▼ 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 NCT03283098_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.

Draft — new file consolidated/NCT03283098_consolidation_corrections.json; replace each <why>, then re-run consolidation.

▼ Consolidation Metadata Process information

consolidated_at	2026-10-03T19:23:29.428081+00:00
source_activity_count	35
unified_activity_count	35
compression_percent	0
match_stats	new: 35

▼ Source Tables 3 tables

table	type	title / purpose	acts	cols	props
T1	main_soa	Table 1a. Schedule of Non-laboratory Assessments Main schedule: non-laboratory assessments across screening, dosing (Days 1-27) and follow-up to Day 55 (EOS)	14	20	2
T2	domain	Table 1b. Schedule of Laboratory Assessments Laboratory assessments on the shared Screening-Day 55 timeline	14	20	2
T3	domain	Table 1c. Schedule of Pharmacokinetic Assessments Pharmacokinetic sampling by time relative to hemodialysis / study drug administration, on the shared Screening-Day 55 timeline	7	20	2

▼ Unified Activities 35 activities

xact_id	activity_name (variations)	parent	match	#	tables	row kind
xact-001	Informed consent		one table	1	T1
xact-002	Eligibility		one table	1	T1
xact-003	Medical and surgical history		one table	1	T1
xact-004	Demographics		one table	1	T1
xact-005	Prior medications		one table	1	T1
xact-006	Body Height		one table	1	T1
xact-007	Body Weight		one table	1	T1
xact-008	Physical exam		one table	1	T1
xact-009	Hemodialysis symptoms		one table	1	T1
xact-010	Investigational product administration		one table	1	T1
xact-011	Vital Signs (BP, HR, RR, TEMP)		one table	1	T1
xact-012	12-lead electrocardiogram		one table	1	T1
xact-013	Adverse Event Monitoring		one table	1	T1
xact-014	Concomitant Medications		one table	1	T1
xact-015	Laboratory Assessments		one table	1	T2	section
xact-016	Hematology, PT, aPTT	Laboratory Assessments	one table	1	T2
xact-017	Clinical Chemistry	Laboratory Assessments	one table	1	T2
xact-018	Albumin	Laboratory Assessments	one table	1	T2
xact-019	Phosphorus	Laboratory Assessments	one table	1	T2
xact-020	Calcium (cCa)	Laboratory Assessments	one table	1	T2
xact-021	Serum or Urine Pregnancy (females only)	Laboratory Assessments	one table	1	T2
xact-022	Serum FSH (female only)	Laboratory Assessments	one table	1	T2
xact-023	Breath Alcohol Screen	Laboratory Assessments	one table	1	T2
xact-024	HIV, Hep C Ab, HBsAg	Laboratory Assessments	one table	1	T2
xact-025	iPTH	Laboratory Assessments	one table	1	T2
xact-026	25(OH) vitamin D	Laboratory Assessments	one table	1	T2
xact-027	Kt/V or URR	Laboratory Assessments	one table	1	T2
xact-028	Anti-drug antibodies	Laboratory Assessments	one table	1	T2
xact-029	Central Laboratory		one table	1	T3	section
xact-030	PK (Pre HD)	Central Laboratory	one table	1	T3
xact-031	PK (SDA + 10 min)	Central Laboratory	one table	1	T3
xact-032	PK (SDA + 30 min)	Central Laboratory	one table	1	T3
xact-033	PK (SDA + 60 min)	Central Laboratory	one table	1	T3
xact-034	PK (SDA + 90 min)	Central Laboratory	one table	1	T3
xact-035	PK (SDA + 18 to 30 hr)	Central Laboratory	one table	1	T3

▼ Unified Annotations 18 annotations (0% dedup from 18)

Footnote (18)

xannot_id	markers	#	text	scope	points to
xannot-001 1	T1:a	1	If a treated subject withdraws before completion of dosing, the investigator will make every effort to perform Day 29 assessments as close to 2 days after the last dose of investigational product as possible.	29/ET (HD)
xannot-002 2	T1:b	1	A physical examination will be performed at screening. Abbreviated physical examinations will be performed on day 1 (unless day 1 occurred more than 2 weeks after screening physical examination), Days 15, 29 and 55. Height will be captured once at screening. Weight will be recorded before dialysis.	Body Height \| Body Weight \| Physical exam
xannot-003 3	T1:c	1	Common symptoms associated with hemodialysis will be captured at screening. Any worsening of hemodialysis symptoms will be reported as an adverse event.	Hemodialysis symptoms
xannot-004 4	T1:d	1	Investigational product will be administered by intravenous (IV) injection over approximately 30 seconds into the venous line with dialysis rinse back at the end of the dialysis session.	Investigational product administration
xannot-005 5	T1:e	1	Subjects will remain seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure. Vital signs will include blood pressure, heart rate, respiratory rate, and oral or ear temperature. Vital signs will be obtained pre-dialysis treatments on scheduled dialysis days, and at ET and on Day 55 (EOS).	Vital Signs (BP, HR, RR, TEMP)
xannot-006 6	T1:f	1	Subjects will remain supine for at least 5 minutes prior to recording 12-lead electrocardiogram (ECG). Screening 12-lead ECG will be recorded prior to hemodialysis. The Day -2 12-lead ECG will be recorded within 4 hours after hemodialysis rinse back. After the last dose of investigational product on Day 27, 12-lead ECGs will be recorded between 18 and 30 hours (recorded on day 28) post-dose.	12-lead electrocardiogram
xannot-007 7	T1:g	1	Adverse events will be monitored and recorded from the dose of investigational product (AMG 416) or placebo. Serious adverse events will be monitored and recorded from the time of informed consent through Day 55.	Adverse Event Monitoring
xannot-008 8	T1:h	1	After Day 28, hemodialysis will continue on study days 29, 31, 34, 36, 38, 41, 43, 45, 48, 50, 52 and 55; data collection and study procedures will only occur on hemodialysis days 29, 34, 41, and 55(EOS).	29/ET (HD)
xannot-009 9	T1:i	1	Demographic information collected at screening includes sex, age, race, and ethnicity.	Demographics
xannot-010 10	T2:a	1	If a treated subject withdraws from study before completion of dosing, the investigator will make every effort to obtain day 29 samples as close to 2 days after the last dose of investigational product as possible.	29/ET (HD)
xannot-011 11	T2:b	1	If screening albumin, phosphorus, cCa, pregnancy, and iPTH tests occur within 7 days prior to start of IP, then Day -2 lab tests can be waived	Albumin \| Phosphorus \| Calcium (cCa) (+2) 5 cells
xannot-012 12	T2:c	1	Blood sample for PT and aPTT will be drawn prior to heparin administration for dialysis. Day 1 hematology and coagulation tests will be performed only if day 1 occurs more than 2 weeks after the screening hematology and coagulation tests.	Hematology, PT, aPTT
xannot-013 13	T2:d	1	Serum samples for albumin and calcium for screening and routine monitoring of predialysis cCa. When albumin is less than 4.0 g/dL, the calcium level will be corrected according to the formula: cCa (mg/dL) = total Ca (mg/dL) + (4 – albumin (g/dL))*0.8. Corrected calcium results will inform dosing/dose withholding at the next hemodialysis treatment.	Albumin \| Calcium (cCa)
xannot-014 14	T2:e	1	Perform Kt/V or URR assessment at screening unless a qualifying Kt/V or URR measurement from within 4 weeks prior to screening assessments is available.	Kt/V or URR
xannot-015 15	T2:f	1	Serum samples for anti-drug antibodies will be collected predialysis on days 1, 29, and 55. Any subjects with positive titers for antibodies to AMG 416 may be asked to return to the clinical research unit to provide additional serum samples.	Anti-drug antibodies
xannot-016 16	T2:g	1	Luteinizing hormone and estradiol levels may additionally be collected if deemed necessary for confirmation of postmenopausal status as described in exclusion criteria section 4.2.4	Serum FSH (female only)	Section 4.2.4
xannot-017 17	T2:t1	1	Time: Pre HD	Hematology, PT, aPTT \| Clinical Chemistry \| Albumin (+10)
xannot-018 18	T3:a	1	Definition of footnote 'a' (on the 29/ET column header) is not printed in the source for Table 1c; only the abbreviation line 'HD = hemodialysis; ET = early termination; SDA = Study drug administration.' follows the table. Probable equivalent (NOT source content for this table): Table 1b footnote a - 'If a treated subject withdraws from study before completion of dosing, the investigator will make every effort to obtain day 29 samples as close to 2 days after the last dose of investigational product as possible.'	29/ET (HD)	Table 1

NCT03283098 — consolidated Schedule of Activities