NCT04004988 — consolidated Schedule of Activities

usdm_data · 1 tables · 20 activities (0% compression) · 14 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
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▼ Main Schedule (14 columns)
ActivityInTable 1
Epoch
[epoch] L1		ScreeningPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 doses2Periods 1 and 2 Study Days – at least 35 days washout between Day 1 doses2Periods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 dosesPeriods 1 and 2 Study Days – at least 35 days washout between Day 1 doses2ED3
Study Day
[study_day] L2		D-28 to D-2D-1D1D2D3D4D5D6D7D8D15D21D36 (±1)
Informed ConsentT1X
Subject Admission to CRUT1X
Tirzepatide Dosing4T10 hour
Subject Discharge from CRU5T1X
Outpatient VisitT1XXXXXXXX
Medical History and DemographicsT1X
Physical Examination /Medical Assessment6T1XPredoseXXX
WeightT1XPredoseXX
HeightT1X
TemperatureT1XPredose
Safety 12-lead ECG1,7T1XPredoseXXXXX
Supine Vital Signs (hours)8T1XPredose, 12244872XXXXX
Clinical Laboratory Tests9T1XPredoseXXXXXX
Pregnancy Test10T1XXXX
FSH test, if applicable11T1X
AEs/Concomitant MedicationsT1XXXXXXXXXXXXXX
Pharmacogenetic Sample1,12T1Predose
Immunogenicity1,13T1PredoseXXX
Blood glucose monitoring (hours)1,14T1Predose, 1224, 364872
PK Sampling (hours)1,15T1Predose, 8, 1224, 36487296120144168336480XX
▼ 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 NCT04004988_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/NCT04004988_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:33.462153+00:00
source_activity_count20
unified_activity_count20
compression_percent0
match_statsnew: 20
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Study Schedule Protocol I8F-MC-GPGS
Main schedule: screening, Periods 1 and 2 (crossover periods sharing one day grid, >=35 days washout between Day 1 doses) and early discontinuation		 20 14 2
▼ Unified Activities 20 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Informed Consent one table 1 T1
xact-002 Subject Admission to CRU one table 1 T1
xact-003 Tirzepatide Dosing one table 1 T1
xact-004 Subject Discharge from CRU one table 1 T1
xact-005 Outpatient Visit one table 1 T1
xact-006 Medical History and Demographics one table 1 T1
xact-007 Physical Examination /Medical Assessment one table 1 T1
xact-008 Weight one table 1 T1
xact-009 Height one table 1 T1
xact-010 Temperature one table 1 T1
xact-011 Safety 12-lead ECG one table 1 T1
xact-012 Supine Vital Signs (hours) one table 1 T1
xact-013 Clinical Laboratory Tests one table 1 T1
xact-014 Pregnancy Test one table 1 T1
xact-015 FSH test, if applicable one table 1 T1
xact-016 AEs/Concomitant Medications one table 1 T1
xact-017 Pharmacogenetic Sample one table 1 T1
xact-018 Immunogenicity one table 1 T1
xact-019 Blood glucose monitoring (hours) one table 1 T1
xact-020 PK Sampling (hours) one table 1 T1
▼ Unified Annotations 17 annotations (0% dedup from 17)
Footnote (17)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:a 1 Specified times are approximate, and actual times will be recorded. Actual sampling time should not exceed 1 hour prior to dosing for the predose sample. Safety 12-lead ECG | Pharmacogenetic Sample | Immunogenicity (+2)
xannot-002 2 T1:b 1 Period 2, Day -1 procedures (pregnancy tests) and some Period 2, Predose procedures (physical examinations, medical assessments, and clinical laboratory assessments) may be omitted if Period 1, D36 (±1) procedure dates occur within 4 days of Period 2 dosing. Period 2, Day 36 (±1) will also be considered as the final follow-up visit. D-1 | D1 | D36 (±1)
xannot-003 3 T1:c 1 Within 7 to 14 days upon confirmation of early discontinuation. ED
xannot-004 4 T1:n1 1 Study drug will be administered after an overnight fast of at least 8 hours. Tirzepatide Dosing
xannot-005 5 T1:n2 1 Subjects’ CRU stay may be extended at the investigator’s discretion for safety monitoring. Subject Discharge from CRU
xannot-006 6 T1:n3 1 Physical examination at screening. Thereafter, targeted reviews and medical assessments as appropriate. Physical Examination /Medical Assessment
xannot-007 7 T1:n4 1 Single safety ECG will be collected. ECGs must be recorded before collecting any blood samples at each timepoint. Subjects must be supine for approximately 5 to 10 minutes before ECG collection, and remain supine but awake during ECG collection. Safety 12-lead ECG
xannot-008 8 T1:n5 1 Additional time points may be added, if warranted and agreed upon between Lilly and the investigator. Supine Vital Signs (hours)
xannot-009 9 T1:n6 1 See Appendix 2 for details. Day 1 predose sample is for baseline only. Clinical Laboratory Tests Appendix 2
xannot-010 10 T1:n7 1 Female subjects only. Serum pregnancy test will be performed at screening and urine pregnancy tests at subsequent visits. Pregnancy Test
xannot-011 11 T1:n8 1 Female subjects considered to be postmenopausal only. Women with confirmed nonchildbearing potential status can be exempted from further pregnancy tests during the study after screening. FSH test, if applicable
xannot-012 12 T1:n9 1 Single sample in Period 1 only. Pharmacogenetic Sample
xannot-013 13 T1:n10 1 Where applicable, collection times should match with PK sampling time points. In the event of immediate or non-immediate drug hypersensitivity reactions, unscheduled samples will be collected as detailed in Section 9.4.6. Subjects with TE ADA at follow-up/ED will undergo additional follow-up as detailed in Section 9.7. Immunogenicity Section 9.4.6 · Section 9.7
xannot-014 14 T1:n11 1 Performed using a bedside glucose monitor. Additional unscheduled measurements may be taken at the discretion of the investigator where clinically indicated. Blood glucose monitoring (hours)
xannot-015 15 T1:n12 1 Up to a 10% deviation from the nominal collection time is permissible as long as actual sampling time is recorded. PK Sampling (hours)
xannot-016 16 T1:g1 1 Note: All sampling times are given relative to dosing (Time 0 hour) with tirzepatide (predose or hours postdose). Unless otherwise indicated, predose procedure may be performed any time prior to dosing. table
xannot-017 17 T1:g2 1 If multiple procedures take place at the same time point, the following order of the procedures should be used: ECGs, vital signs, PK sample (record of actual PK sampling time is the priority), clinical laboratory sample, immunogenicity, blood glucose and pharmacogenetic sample. table