NCT05176314 — consolidated Schedule of Activities

usdm_data · 1 tables · 24 activities (0% compression) · 21 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
Near match across tables
Near match, different parent
| Annotations:
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 in Unified Annotations: show where it applies
| Cells:
Common
▼ Main Schedule (21 columns)
ActivityInTable 1
Epoch
[epoch] L1		ScreeningTreatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)Treatment Period (Study Days)1FU/ED2
Study Day
[study_day] L2		(D-42 to -2)-112345678910111213141516171824 (± 2 days)
Informed consentT1X
Admission to CRUT1X
Discharge from CRUT1X
Outpatient visitT1XX
Medical history and demographicsT1X
Participant eligibilityT1XX
Rosuvastatin administrationT1XXX
Pirtobrutinib administrationT1XXXXXXXXXXXX
HeightT1X
WeightT1X
Pregnancy test3T1XXX
Urine drug screen (including cotinine)T1XX
Ethanol testT1X
Supine vital signs (PR and BP)4T1XP, 2 h8,924 h9P, 2 h8,924 h9P, 2 h8,924 h9XX
Oral body temperatureT1X
12-lead ECGT1XP8XP8XP8XXX
Clinical laboratory testsT1XP8XP8XP8XXX
Physical examination5T1XXX
Genetic blood sample for screeningT1X
Rosuvastatin PK samples7T1P, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 h8,924 h948 h972 h996 h9P, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 h6,8,924 h948 h972 h996 h9120 h9P, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 h8,924 h948 h972 h996 h9120 h9
Adverse event reviewT1XXXXXXXXXXXXXXXXXXXXX
Concomitant medication reviewT1XXXXXXXXXXXXXXXXXXXXX
CCIT1
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 NCT05176314_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/NCT05176314_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:44.719391+00:00
source_activity_count24
unified_activity_count24
compression_percent0
match_statsnew: 24
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Schedule of Activities (SoA)
Main schedule: screening, in-clinic treatment period Days -1 to 18 (rosuvastatin and pirtobrutinib administration, rosuvastatin PK sampling), and FU/ED visit on Day 24		 24 21 2
▼ Unified Activities 24 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Informed consent one table 1 T1
xact-002 Admission to CRU one table 1 T1
xact-003 Discharge from CRU one table 1 T1
xact-004 Outpatient visit one table 1 T1
xact-005 Medical history and demographics one table 1 T1
xact-006 Participant eligibility one table 1 T1
xact-007 Rosuvastatin administration one table 1 T1
xact-008 Pirtobrutinib administration one table 1 T1
xact-009 Height one table 1 T1
xact-010 Weight one table 1 T1
xact-011 Pregnancy test one table 1 T1
xact-012 Urine drug screen (including cotinine) one table 1 T1
xact-013 Ethanol test one table 1 T1
xact-014 Supine vital signs (PR and BP) one table 1 T1
xact-015 Oral body temperature one table 1 T1
xact-016 12-lead ECG one table 1 T1
xact-017 Clinical laboratory tests one table 1 T1
xact-018 Physical examination one table 1 T1
xact-019 Genetic blood sample for screening one table 1 T1
xact-020 Rosuvastatin PK samples one table 1 T1
xact-021 Adverse event review one table 1 T1
xact-022 Concomitant medication review one table 1 T1
xact-023 CCI Concomitant medication review one table 1 T1
xact-024 CCI Concomitant medication review one table 1 T1
▼ Unified Annotations 9 annotations (0% dedup from 9)
Footnote (7)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:a 1 Participants will be discharged from the CRU on Day 18 once all study procedures are completed. 18
xannot-002 2 T1:b 1 Participants will attend an outpatient follow-up visit 7 (± 2) days after the final dose of study intervention. If participants are not able to attend the CRU for this visit, the CRU should contact the participant via phone call to conduct adverse event and concomitant medication review. If applicable, ED assessments should be performed on the day of discontinuation (or as close to it as possible). 24 (± 2 days)
xannot-003 3 T1:c 1 Female participants only. Serum pregnancy test at screening and urine pregnancy test at all other times. Pregnancy test
xannot-004 4 T1:d 1 Definition not printed in the source: the footnote block on document page 12 lists a, b, c and e as text, while the positions where footnote 'd' would print are covered by redaction boxes labelled 'CCI'. [remainder redacted in source] Supine vital signs (PR and BP)
xannot-005 5 T1:e 1 Complete physical examination at check-in, discharge from CRU, and follow-up. Additional symptom-driven physical examinations may be performed at the discretion of the investigator. Physical examination
xannot-006 6 T1:f 1 Definition not printed in the source: the footnote block on document page 12 lists a, b, c and e as text, while the positions where footnote 'f' would print are covered by redaction boxes labelled 'CCI'. [remainder redacted in source] Rosuvastatin PK samples 1 cells
xannot-007 7 T1:g 1 Definition not printed in the source: the footnote block on document page 12 lists a, b, c and e as text, while the positions where footnote 'g' would print are covered by redaction boxes labelled 'CCI'. [remainder redacted in source] Rosuvastatin PK samples
Legend (2)
xannot_idmarkers#textscopepoints to
xannot-008 8 T1:P 1 P = predose Supine vital signs (PR and BP) | 12-lead ECG | Clinical laboratory tests (+1) 12 cells
xannot-009 9 T1:h 1 h = hours postdose Supine vital signs (PR and BP) | Rosuvastatin PK samples 23 cells