NCT05259917 · 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 (6 columns)

Activity	In	Table 1
Visit [visit] L1		Screening	Randomization¹	Treatment Period²	Treatment Period²	Treatment Period²	Final Visit/ET³
Eligible HAE attack [visit] L2				1st eligible HAE attack	2nd eligible HAE attack	3rd eligible HAE attack
In-clinic^4,5 [modality]		X	X	X	X	X	X
TeleVisit^4,5 [modality]		X	X	X	X	X	X
Informed Consent/Assent⁶	T1	X
Eligibility Assessment	T1	X	X
HAE Diagnostic Lab Test⁷	T1	X
Medical History⁸	T1	X
12-lead ECG⁹	T1	X					X
Demographics¹⁰	T1	X
Physical Examination¹¹	T1	X					X
Vital Signs¹²	T1	X					X
Safety Laboratory¹³	T1	X					X
Pregnancy Test¹⁴	T1	X					X
Randomize patient in RTSM	T1		X
Patient diary training	T1	X	X
Patient diary retraining	T1			X	X	X
Conventional on-demand treatment washout¹⁵	T1			↔	↔	↔
Dose¹⁶	T1			X	X	X
IMP dispensing/return/accountability¹⁷	T1		X				X
PGI-S¹⁸	T1			X	X	X
PGI-C¹⁸	T1			X	X	X
VAS¹⁸	T1			X	X	X
GA-NRS¹⁸	T1			X	X	X
Concomitant Medication Review	T1	↔	↔	↔	↔	↔	↔
Adverse Event Review¹⁹	T1	↔	↔	↔	↔	↔	↔

Activity

Table 1

Visit
[visit] L1

Screening

Randomization¹

Treatment Period²

Final Visit/ET³

Eligible HAE attack
[visit] L2

1st eligible HAE attack

2nd eligible HAE attack

3rd eligible HAE attack

In-clinic^4,5
[modality]

TeleVisit^4,5
[modality]

Informed Consent/Assent⁶

Eligibility Assessment

HAE Diagnostic Lab Test⁷

Medical History⁸

12-lead ECG⁹

Demographics¹⁰

Physical Examination¹¹

Vital Signs¹²

Safety Laboratory¹³

Pregnancy Test¹⁴

Randomize patient in RTSM

Patient diary training

Patient diary retraining

Conventional on-demand treatment washout¹⁵

↔

Dose¹⁶

IMP dispensing/return/accountability¹⁷

PGI-S¹⁸

PGI-C¹⁸

VAS¹⁸

GA-NRS¹⁸

Concomitant Medication Review

↔

Adverse Event Review¹⁹

↔

▼ 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 NCT05259917_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/NCT05259917_consolidation_corrections.json; replace each <why>, then re-run consolidation.

▼ Consolidation Metadata Process information

consolidated_at	2026-10-03T19:23:44.918900+00:00
source_activity_count	22
unified_activity_count	22
compression_percent	0
match_stats	new: 22

▼ Source Tables 1 tables

table	type	track	title / purpose	acts	cols	props
T1	main_soa		Schedule of Events Main schedule: Screening, Randomization, three event-driven eligible-HAE-attack televisits, Final Visit/ET	22	6	4

▼ Unified Activities 22 activities

xact_id	activity_name (variations)	match	#	tables
xact-001	Informed Consent/Assent	one table	1	T1
xact-002	Eligibility Assessment	one table	1	T1
xact-003	HAE Diagnostic Lab Test	one table	1	T1
xact-004	Medical History	one table	1	T1
xact-005	12-lead ECG	one table	1	T1
xact-006	Demographics	one table	1	T1
xact-007	Physical Examination	one table	1	T1
xact-008	Vital Signs	one table	1	T1
xact-009	Safety Laboratory	one table	1	T1
xact-010	Pregnancy Test	one table	1	T1
xact-011	Randomize patient in RTSM	one table	1	T1
xact-012	Patient diary training	one table	1	T1
xact-013	Patient diary retraining	one table	1	T1
xact-014	Conventional on-demand treatment washout	one table	1	T1
xact-015	Dose	one table	1	T1
xact-016	IMP dispensing/return/accountability	one table	1	T1
xact-017	PGI-S	one table	1	T1
xact-018	PGI-C	one table	1	T1
xact-019	VAS	one table	1	T1
xact-020	GA-NRS	one table	1	T1
xact-021	Concomitant Medication Review	one table	1	T1
xact-022	Adverse Event Review	one table	1	T1

▼ Unified Annotations 19 annotations (0% dedup from 19)

Footnote (19)

xannot_id	markers	#	text	scope
xannot-001 1	T1:a	1	Randomization to occur within 4 weeks of the Screening Visit. The Randomization Visit may be a televisit or an in-clinic visit.	Randomization
xannot-002 2	T1:b	1	For each of the 3 eligible HAE attacks, a televisit will occur by the next working day after the completion of the patient diary (visit window: +1 week). A televisit must occur before treating the next eligible attack.	Treatment Period \| Treatment Period \| Treatment Period
xannot-003 3	T1:c	1	Once 3 HAE attacks have been treated with IMP, or upon patient ET, the patient should return to the clinic for the final visit as soon as possible within 1 week of completing all patient diary assessments. Whenever possible this visit should be completed prior to starting any new medication or treatment.	Final Visit/ET
xannot-004 4	T1:d	1	If an in-clinic visit cannot be conducted (e.g. in the event of a pandemic or other reason that prevents the patient from attending in-clinic visits), home health visits will be used to perform these visits. Information captured during a home health visit will mirror that captured during an in-clinic visit.	In-clinic
xannot-005 5	T1:e	1	A televisit can be conducted via a telephone call or via an interactive audio/video system.	TeleVisit
xannot-006 6	T1:f	1	Consent and assent may be collected through e-consent if allowed through country and site regulations.	Informed Consent/Assent
xannot-007 7	T1:g	1	Diagnostic testing must be available for patients without genetic confirmation of HAE type I or II.	HAE Diagnostic Lab Test
xannot-008 8	T1:h	1	Medical history includes any relevant previous and concurrent diseases, HAE disease history including the attack history and corresponding treatment for the past 3 months; therapies and supplements taken within the past 4 weeks; and previous participation in interventional clinical trials in the past 4 weeks.	Medical History
xannot-009 9	T1:i	1	ECG to be recorded after patient has rested supine for at least 5 minutes.	12-lead ECG
xannot-010 10	T1:j	1	Demographics: Year of birth; height (meters [m]; without shoes); weight (kilograms [kg]); race and ethnicity (if allowed); and sex.	Demographics
xannot-011 11	T1:k	1	Complete physical examination at Screening only, all others will be symptom directed. In the case of a home health visit, the home healthcare nurse will conduct an abbreviated physical examination, and the Investigator will conduct the symptom-directed physical examination via televisit.	Physical Examination
xannot-012 12	T1:l	1	Vital signs include pulse rate, respiratory rate, and systolic and diastolic blood pressure after patient has been resting at least 5 minutes.	Vital Signs
xannot-013 13	T1:m	1	Laboratory assessments, including C1-INH functional level, performed by a central laboratory; repeat laboratory assessments may be performed.	Safety Laboratory
xannot-014 14	T1:n	1	Serum pregnancy test will be performed on females of childbearing potential at Screening and at the Final/ET visit.	Pregnancy Test
xannot-015 15	T1:o	1	If a patient takes conventional on-demand treatment during the trial, a 48-hour washout period is required prior to the subsequent dosing with IMP.	Conventional on-demand treatment washout
xannot-016 16	T1:p	1	Eligible attacks should be treated with IMP as soon as possible after recognition of the start of the attack. A minimum 48-hour washout period is required between each eligible attack and last dose of IMP or conventional on-demand treatment. After the first dose of IMP and prior to the second dose or conventional on-demand treatment, patients will be required to call a designated Study Call Center to be reminded of the repeat dosing criteria. The Call Center staff will remind patients of the rules for re-dosing and the eDiary assessment requirements.	Dose
xannot-017 17	T1:q	1	Arrangements will be made to dispense the assigned IMP. The IMP will be shipped to the patient via a courier service or will be dispensed at the trial clinic as required by local regulations or per the site’s local practice, as described in the Pharmacy Manual. Confirmation of dosing compliance will be performed at each of the HAE attack televisits. All unused IMP and packaging will be returned at the in-clinic Final Visit/ET Visit. If the Final Visit/ET Visit is performed by Home Health, arrangements will be made to return any unused IMP and packaging via courier.	IMP dispensing/return/accountability
xannot-018 18	T1:r	1	Patients will complete timed assessments of HAE attack symptoms through 48 hours following first dose of IMP. Patient assessments will be performed as outlined in Table S1.	PGI-S \| PGI-C \| VAS (+1)
xannot-019 19	T1:s	1	Adverse events recorded from the first dose of KVD900 or placebo up to and including to Final Visit/ET. Serious AEs recorded from the time of signing the informed consent up to and including the Final Visit/ET.	Adverse Event Review

NCT05259917 — consolidated Schedule of Activities