NCT03548987 — consolidated Schedule of Activities

usdm_data · 1 tables · 69 activities (0% compression) · 25 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
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▼ Main Schedule (25 columns)
ActivityInTable 1
Period
[epoch] L1		ScreeningRun-inRun-inRun-inRun-inRun-inRun-inRun-inRun-inRun-inRun-inRandomisationMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodEnd of treatmentEnd of trial
Visit(V), Phone (P)
[visit] L2		V1V2P3V4P5V6P7V8P9V10P11V12V13V14P15V16P17V18P19V20P21V22P23V24V25
Timing of Visit (Weeks)
[week] L3		-10246810121416182024283236404448525660646875
Visit Window (Days)
[window]		-7 to 00±3±3±3±3±3±3±3±3±3±3±3±3±3±3±3±3±3±3±3±3±3±30 to +5
SUBJECT RELATED INFORMATION AND ASSESSMENTST1
Informed consent and Demography1,5T1X
Childbearing potential2,6T1X
Inclusion criteria7T1XX
Exclusion criteria8T1XX
Run-in criteria9T1X
Randomisation criteria and randomisation3,10T1X
Medical history/Concomitant illness11T1X
Weight History12T1X
History of Gallbladder Disease11T1X
History of Breast Neoplasm2,11T1X
History of Colon Neoplasm11T1X
History of Skin Cancer11T1X
History of Psychiatric Disorder11T1X
Tobacco Use4T1X
Concomitant medication13T1XXXXXXXXXXXXXXXXXXXXXXXX
Trial product compliance14,15T1XXXXXXXXXXXXXXXXXXXXXX
Evaluation of lipid-lowering treatment12T1XX
Evaluation of antihypertensive treatment12T1XX
Evaluation of glycaemic status12T1XXX
EFFICACYT1
Body measurements16T1
HeightT1X
Body WeightT1XXXXXXXXXXXXXXX
Waist CircumferenceT1XXXXXXXXXXXXXX
HbA1cT1XXXXX
Fasting plasma glucoseT1XXXX
Fasting serum insulinT1XXX
Lipids17T1XXX
Vital Signs18,19T1
Systolic Blood PressureT1XXXXXXXXXXXXXXX
Diastolic Blood PressureT1XXXXXXXXXXXXXXX
PulseT1XXXXXXXXXXXXXXX
Clinical Outcome Assessments20T1
Short Form-36 (SF-36)T1XXXXXXX
Weight Related Sign and Symptom Measure (WRSSM)T1XXXXXXX
Patient Global Impression of Severity (PGI-S)T1XXXXXXX
Patient Global Impression of Change (PGI-C)T1XXXXXXX
Stanford Presenteeism Scale (SPS-6)T1XXX
Patient Health Questionnaire – 9 (PHQ-9)T1XXXXXXX
Columbia Suicide Severity Rating Scale (C-SSRS)T1XXXXXXX
SAFETYT1
Physical examination21T1XXX
Pregnancy test6,22T1XXXXXXXXXXXXXXX
ECG23T1XXX
Adverse event24,25T1XXXXXXXXXXXXXXXXXXXXXXXX
Technical complaint26,27T1XXXXXXXXXXXXXXXXXXXXXX
Breast neoplasms follow-up2,11T1XX
Colon neoplasms follow-up11T1XX
Haematology17T1XXXX
Biochemistry17T1XXXX
Vital Signs18,19T1
Clinical Outcome Assessments28T1
TRIAL MATERIALT1
First date on trial productT1X
IWRS sessionT1XXXXXXXXXXX
Administration of trial product14,29T1
Dispensing visitT1XXXXXXXXX
Drug accountabilityT1XXXXXXXXXX
REMINDERST1
Criteria for discontinuation30T1XXXXXXXXXXXXXXXXXXXXXX
Barriers and motivation interview12T1X
Diet and physical activity counselling31T1XXXXXXXXXXXXXXXXXX
Training in trial product, pen-handling32T1XXXXXXXXXXX
Hand out direction for use32T1X
Hand out dose reminder card14T1XXXXX
Hand out and instruct in food diary12T1X
Hand out ID cardT1X
Attend visit fasting33T1XXXX
▼ 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 NCT03548987_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/NCT03548987_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:31.447523+00:00
source_activity_count69
unified_activity_count69
compression_percent0
match_statsnew: 69
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Flowchart
Main schedule of activities across screening, run-in, randomisation, maintenance, end of treatment and end of trial		 69 25 4
▼ Unified Activities 69 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 SUBJECT RELATED INFORMATION AND ASSESSMENTS one table 1 T1 section
xact-002 Informed consent and Demography SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-003 Childbearing potential SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-004 Inclusion criteria SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-005 Exclusion criteria SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-006 Run-in criteria SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-007 Randomisation criteria and randomisation SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-008 Medical history/Concomitant illness SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-009 Weight History SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-010 History of Gallbladder Disease SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-011 History of Breast Neoplasm SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-012 History of Colon Neoplasm SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-013 History of Skin Cancer SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-014 History of Psychiatric Disorder SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-015 Tobacco Use SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-016 Concomitant medication SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-017 Trial product compliance SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-018 Evaluation of lipid-lowering treatment SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-019 Evaluation of antihypertensive treatment SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-020 Evaluation of glycaemic status SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-021 EFFICACY one table 1 T1 section
xact-022 Body measurements EFFICACY one table 1 T1
xact-023 Height Body measurements one table 1 T1
xact-024 Body Weight Body measurements one table 1 T1
xact-025 Waist Circumference Body measurements one table 1 T1
xact-026 HbA1c EFFICACY one table 1 T1
xact-027 Fasting plasma glucose EFFICACY one table 1 T1
xact-028 Fasting serum insulin EFFICACY one table 1 T1
xact-029 Lipids EFFICACY one table 1 T1
xact-030 Vital Signs EFFICACY one table 1 T1
xact-031 Systolic Blood Pressure Vital Signs one table 1 T1
xact-032 Diastolic Blood Pressure Vital Signs one table 1 T1
xact-050 Pulse Vital Signs one table 1 T1
xact-033 Clinical Outcome Assessments EFFICACY one table 1 T1
xact-034 Short Form-36 (SF-36) Clinical Outcome Assessments one table 1 T1
xact-035 Weight Related Sign and Symptom Measure (WRSSM) Clinical Outcome Assessments one table 1 T1
xact-036 Patient Global Impression of Severity (PGI-S) Clinical Outcome Assessments one table 1 T1
xact-037 Patient Global Impression of Change (PGI-C) Clinical Outcome Assessments one table 1 T1
xact-038 Stanford Presenteeism Scale (SPS-6) Clinical Outcome Assessments one table 1 T1
xact-052 Patient Health Questionnaire – 9 (PHQ-9) Clinical Outcome Assessments one table 1 T1
xact-053 Columbia Suicide Severity Rating Scale (C-SSRS) Clinical Outcome Assessments one table 1 T1
xact-039 SAFETY one table 1 T1 section
xact-040 Physical examination SAFETY one table 1 T1
xact-041 Pregnancy test SAFETY one table 1 T1
xact-042 ECG SAFETY one table 1 T1
xact-043 Adverse event SAFETY one table 1 T1
xact-044 Technical complaint SAFETY one table 1 T1
xact-045 Breast neoplasms follow-up SAFETY one table 1 T1
xact-046 Colon neoplasms follow-up SAFETY one table 1 T1
xact-047 Haematology SAFETY one table 1 T1
xact-048 Biochemistry SAFETY one table 1 T1
xact-049 Vital Signs SAFETY one table 1 T1
xact-051 Clinical Outcome Assessments SAFETY one table 1 T1
xact-054 TRIAL MATERIAL one table 1 T1 section
xact-055 First date on trial product TRIAL MATERIAL one table 1 T1
xact-056 IWRS session TRIAL MATERIAL one table 1 T1
xact-057 Administration of trial product TRIAL MATERIAL one table 1 T1
xact-058 Dispensing visit Administration of trial product one table 1 T1
xact-059 Drug accountability Administration of trial product one table 1 T1
xact-060 REMINDERS one table 1 T1 section
xact-061 Criteria for discontinuation REMINDERS one table 1 T1
xact-062 Barriers and motivation interview REMINDERS one table 1 T1
xact-063 Diet and physical activity counselling REMINDERS one table 1 T1
xact-064 Training in trial product, pen-handling REMINDERS one table 1 T1
xact-065 Hand out direction for use REMINDERS one table 1 T1
xact-066 Hand out dose reminder card REMINDERS one table 1 T1
xact-067 Hand out and instruct in food diary REMINDERS one table 1 T1
xact-068 Hand out ID card REMINDERS one table 1 T1
xact-069 Attend visit fasting REMINDERS one table 1 T1
▼ Unified Annotations 33 annotations (0% dedup from 33)
Footnote (4)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:a 1 Demography consists of date of birth, sex, ethnicity, and race (according to local regulation) Informed consent and Demography
xannot-002 2 T1:b 1 For all female subjects Childbearing potential | History of Breast Neoplasm | Breast neoplasms follow-up
xannot-003 3 T1:c 1 If subjects not fulfil randomisation criteria see Section 6.3.2 Randomisation criteria and randomisation Section 6.3.2
xannot-004 4 T1:d 1 Smoking is defined as smoking at least one cigarette or equivalent daily Tobacco Use
Source Note (29)
xannot_idmarkers#textscopepoints to
xannot-005 5 T1:pr1 1 Appendix 3 Informed consent and Demography Appendix 3
xannot-006 6 T1:pr2 1 Appendix 5 Childbearing potential | Pregnancy test Appendix 5
xannot-007 7 T1:pr3 1 Section 6.1 Inclusion criteria Section 6.1
xannot-008 8 T1:pr4 1 Section 6.2 Exclusion criteria Section 6.2
xannot-009 9 T1:pr5 1 Section 6.3.1 Run-in criteria Section 6.3.1
xannot-010 10 T1:pr6 1 Section 6.3.2 Randomisation criteria and randomisation Section 6.3.2
xannot-011 11 T1:pr7 1 Section 9.4 Medical history/Concomitant illness | History of Gallbladder Disease | History of Breast Neoplasm (+5) Section 9.4
xannot-012 12 T1:pr8 1 Section 9 Weight History | Evaluation of lipid-lowering treatment | Evaluation of antihypertensive treatment (+3) Section 9
xannot-013 13 T1:pr9 1 Section 7.7 Concomitant medication Section 7.7
xannot-014 14 T1:pr10 1 Section 7.1 Trial product compliance | Administration of trial product | Hand out dose reminder card Section 7.1
xannot-015 15 T1:pr11 1 Section 7.6 Trial product compliance Section 7.6
xannot-016 16 T1:pr12 1 Section 9.1.1 Body measurements Section 9.1.1
xannot-017 17 T1:pr13 1 Appendix 2 Lipids | Haematology | Biochemistry Appendix 2
xannot-018 18 T1:pr14 1 Section 6.4.2 Vital Signs | Vital Signs Section 6.4.2
xannot-019 19 T1:pr15 1 Section 9.4.3 Vital Signs | Vital Signs Section 9.4.3
xannot-020 20 T1:pr16 1 Section 9.1.2 Clinical Outcome Assessments Section 9.1.2
xannot-021 21 T1:pr17 1 Section 9.4.2 Physical examination Section 9.4.2
xannot-022 22 T1:pr18 1 Section 9.4.5 Pregnancy test Section 9.4.5
xannot-023 23 T1:pr19 1 Section 9.4.4 ECG Section 9.4.4
xannot-024 24 T1:pr20 1 Section 9.2 Adverse event Section 9.2
xannot-025 25 T1:pr21 1 Appendix 4 Adverse event Appendix 4
xannot-026 26 T1:pr22 1 Section 9.2.9 Technical complaint Section 9.2.9
xannot-027 27 T1:pr23 1 Appendix 6 Technical complaint Appendix 6
xannot-028 28 T1:pr24 1 Section 9.4.1 Clinical Outcome Assessments Section 9.4.1
xannot-029 29 T1:pr25 1 Section 7.5 Administration of trial product Section 7.5
xannot-030 30 T1:pr26 1 Section 8.1 Criteria for discontinuation Section 8.1
xannot-031 31 T1:pr27 1 Section 7.1.2 Diet and physical activity counselling Section 7.1.2
xannot-032 32 T1:pr28 1 Section 7.1.1 Training in trial product, pen-handling | Hand out direction for use Section 7.1.1
xannot-033 33 T1:pr29 1 Section 6.4.1 Attend visit fasting Section 6.4.1