NCT05324124 — consolidated Schedule of Activities

usdm_data · 1 tables · 20 activities (0% compression) · 15 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
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Near match, different parent
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▼ Main Schedule (15 columns)
ActivityInTable 1
Study period
[epoch] L1		ScreeningTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodTreatment PeriodFollow-Up phone call
Study day
[study_day] L2		-28 to -2 days prior to Day 1-11234567891011EDwithin 7 to 10 days after last dose
Days
[other]		DaysDaysDaysDaysDaysDaysDaysDaysDaysDaysDaysDaysDays
Informed consentT1X
Inclusion and exclusion criteriaT1X
DemographyT1X
Participant admission to CRUT1X
Participant discharge from CRU1T1X
Outpatient visitT1X
Medical historyT1X
Medical assessment2T1XPPXX
Height and weight3T1XXX
Serum or urine pregnancy test (women of childbearing potential only)4T1XXXX
Follicle-stimulating hormone (women of non-childbearing potential only)T1X
Human immunodeficiency virus, hepatitis B and C screenT1X
12-lead ECG5T1XP, 2hXP, 2hXXX
Vital signs (supine), pulse rate, and blood pressure6T1XP, 1, 2h24hXXP, 1,2h24hXXX
Clinical laboratory tests7T1XP24hXP24hXX
Genetic sampleT1X
Selpercatinib administration8T1XX
Adverse event /Serious adverse event reviewT1XX↔↔↔↔↔↔↔↔↔↔↔X
Concomitant medication reviewT1XX↔↔↔↔↔↔↔↔↔↔↔X
CCIT1
▼ 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 NCT05324124_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/NCT05324124_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:45.088284+00:00
source_activity_count20
unified_activity_count20
compression_percent0
match_statsnew: 20
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Schedule of Activities (SoA)
Main study schedule: screening, 11-day inpatient treatment period, ED and follow-up phone call		 20 15 3
▼ Unified Activities 20 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Informed consent one table 1 T1
xact-002 Inclusion and exclusion criteria one table 1 T1
xact-003 Demography one table 1 T1
xact-004 Participant admission to CRU one table 1 T1
xact-005 Participant discharge from CRU one table 1 T1
xact-006 Outpatient visit one table 1 T1
xact-007 Medical history one table 1 T1
xact-008 Medical assessment one table 1 T1
xact-009 Height and weight one table 1 T1
xact-010 Serum or urine pregnancy test (women of childbearing potential only) one table 1 T1
xact-011 Follicle-stimulating hormone (women of non-childbearing potential only) one table 1 T1
xact-012 Human immunodeficiency virus, hepatitis B and C screen one table 1 T1
xact-013 12-lead ECG one table 1 T1
xact-014 Vital signs (supine), pulse rate, and blood pressure one table 1 T1
xact-015 Clinical laboratory tests one table 1 T1
xact-016 Genetic sample one table 1 T1
xact-017 Selpercatinib administration one table 1 T1
xact-018 Adverse event /Serious adverse event review one table 1 T1
xact-019 Concomitant medication review one table 1 T1
xact-020 CCI Concomitant medication review one table 1 T1
▼ Unified Annotations 8 annotations (0% dedup from 8)
Footnote (7)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:cm1 1 A study participant may be required to stay later than Day 11 for management or monitoring of an AE or a clinically significant finding, at the discretion of the investigator. Participant discharge from CRU
xannot-002 2 T1:cm2 1 Full medical assessment to be performed at screening, and symptom driven examination to be done at other/any time point at physician’s discretion. Medical assessment
xannot-003 3 T1:cm3 1 Height and weight to be measured at screening; weight only to be measured at Day 11 or ED as appropriate. Height and weight
xannot-004 4 T1:cm4 1 Serum pregnancy tests will be performed at screening and urine pregnancy test at all other time points Serum or urine pregnancy test (women of childbearing potential only)
xannot-005 5 T1:cm5 1 Single ECGs are required. 12-lead ECG
xannot-006 6 T1:cm6 1 Time points may be added, if warranted and agreed upon between Lilly and the investigator. Vital signs (supine), pulse rate, and blood pressure
xannot-008 8 T1:cm8 1 Participant consumes high-fat meal within 30 minutes prior to dose based on randomization. Selpercatinib administration
Source Note (1)
xannot_idmarkers#textscopepoints to
xannot-007 7 T1:cm7 1 See Appendix 10.2, Clinical Laboratory Tests, for details. Clinical laboratory tests Appendix 10.2