NCT03548935 — consolidated Schedule of Activities

usdm_data · 1 tables · 78 activities (0% compression) · 25 columns · study-schedule-consolidated v1.0 · Layer 3
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▼ Main Schedule (25 columns)
ActivityInTable 1
Study period
[epoch] L1		ScreeningRandomisationDose escalation periodDose escalation periodDose escalation periodDose escalation periodDose escalation periodDose escalation periodDose escalation periodDose escalation periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodEnd of treatmentEnd of trial
Visit (V), Phone (P)
[visit] L2		V1V2V3V4P5V6P7V8P9V10P11V12P13V14P15V16P17V18P19V20P21V22P23V24V25
Timing of Visit (Weeks)
[week] L3		-10246810121416182024283236404448525660646875
Visit Window (Days)
[window]		-7 to 0±0±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 Demography1,8T1X
Childbearing potential2,9T1X
Inclusion criteria10T1XX
Exclusion criteria11T1XX
Randomisation criteria and randomisation12T1X
Medical history/Concomitant illness13T1X
Weight History14T1X
History of Gallbladder Disease13T1X
History of Breast Neoplasm2,13T1X
History of Colon Neoplasm13T1X
History of Skin Cancer13T1X
History of Psychiatric Disorder13T1X
Tobacco Use3,15T1X
Concomitant medication16T1XXXXXXXXXXXXXXXXXXXXXXXX
Trial Product Compliance17,18T1XXXXXXXXXXXXXXXXXXXXXX
Evaluation of lipid-lowering treatment14T1XX
Evaluation of antihypertensive treatment14T1XX
Evaluation of glycaemic status14T1XXX
Evaluation of diet and physical activity14T1XXXXXXXXXXX
EFFICACYT1
Body measurements19T1
HeightT1X
Body WeightT1XXXXXXXXXXXXXXX
Waist CircumferenceT1XXXXXXXXXXXXX
HbA1c20T1XXXXX
Fasting plasma glucose20T1XXXX
Fasting serum insulin20T1XX
Lipids20T1XXX
Biomarkers20,21T1XXX
Vital Signs22T1
Systolic blood PressureT1XXXXXXXXXXXXXX
Diastolic Blood PressureT1XXXXXXXXXXXXXX
PulseT1XXXXXXXXXXXXXX
Clinical Outcome Assessments23T1
Short Form-36 (SF-36)T1XXXXXXX
Impact of weight on quality of life – Lite Clinical Trials version (IWQoL-Lite for CT)T1XXXXXXX
Patient Global Impression of Status (PGI-S)T1XXXXXXX
Patient Global Impression of Change (PGI-C)T1XXXXXXX
Stanford Presenteeism Scale-6 (SPS-6)T1XXX
International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF)2T1XX
Patient Health Questionnaire–9 (PHQ-9)31T1XXXXXXX
Columbia-Suicide Severity Rating Scale (C-SSRS)31T1XXXXXXX
DEXA scan4,14T1X5X
SAFETYT1
Physical examination24T1XX
Pregnancy test9,25T1XXXXXXXXXXXXXX
ECG26T1XXX
Adverse event27,28T1XXXXXXXXXXXXXXXXXXXXXXXX
Technical complaint28,29T1XXXXXXXXXXXXXXXXXXXXXX
Breast neoplasms follow-up2,13T1XX
Colon neoplasms follow-up13T1XX
Haematology20T1XXXX
Biochemistry20T1XXXX
Anti-Semaglutide Antibody30T1XXXXXXXXX
Vital Signs22T1
Clinical Outcome Assessments31T1
OTHER ASSESSMENTST1
Semaglutide plasma concentration32T1XXXXXXXX
Biosamples for future analysis6,33T1XX
TRIAL MATERIALT1
First date on trial productT1X
IWRS sessionT1XXXXXXXXXXX
Administration of trial product17,34T1
Dispensing visitT1XXXXXXXXX
Drug accountabilityT1XXXXXXXXXX
REMINDERST1
Criteria for discontinuation35T1XXXXXXXXXXXXXXXXXXXXX
Barriers and motivation interview14T1X
Diet and physical activity counselling36T1XXXXXXXXXXXXXXXXXX
Training in trial product, pen-handling37T1XXXXXXXXXXXX
Hand out direction for use37T1X
Hand out dose reminder card17T1XXXXX
Hand out and instruct in food diary14T1X
Hand out and instruct in PK dairy14T1XXXXXXX
Collect, review and transcribe diariesT1XXXXXXXXXXXXX
Hand out ID cardT1X
Attend visit fasting15T1XXXXX7
▼ 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 NCT03548935_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/NCT03548935_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:30.712361+00:00
source_activity_count78
unified_activity_count78
compression_percent0
match_statsnew: 78
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Flowchart
Main schedule of activities for the whole trial (screening, randomisation, dose escalation, maintenance, end of treatment, end of trial)		 78 25 4
▼ Unified Activities 78 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 Randomisation criteria and randomisation SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-007 Medical history/Concomitant illness SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-008 Weight History SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-009 History of Gallbladder Disease SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-010 History of Breast Neoplasm SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-011 History of Colon Neoplasm SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-012 History of Skin Cancer SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-013 History of Psychiatric Disorder SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-014 Tobacco Use SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-015 Concomitant medication SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-016 Trial Product Compliance SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-017 Evaluation of lipid-lowering treatment SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-018 Evaluation of antihypertensive treatment SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-019 Evaluation of glycaemic status SUBJECT RELATED INFORMATION AND ASSESSME one table 1 T1
xact-020 Evaluation of diet and physical activity 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 Biomarkers EFFICACY one table 1 T1
xact-031 Vital Signs EFFICACY one table 1 T1
xact-032 Systolic blood Pressure Vital Signs one table 1 T1
xact-033 Diastolic Blood Pressure Vital Signs one table 1 T1
xact-054 Pulse Vital Signs one table 1 T1
xact-034 Clinical Outcome Assessments EFFICACY one table 1 T1
xact-035 Short Form-36 (SF-36) Clinical Outcome Assessments one table 1 T1
xact-036 Impact of weight on quality of life – Lite Clinical Trials version (IWQoL-Lite for CT) Clinical Outcome Assessments one table 1 T1
xact-037 Patient Global Impression of Status (PGI-S) Clinical Outcome Assessments one table 1 T1
xact-038 Patient Global Impression of Change (PGI-C) Clinical Outcome Assessments one table 1 T1
xact-039 Stanford Presenteeism Scale-6 (SPS-6) Clinical Outcome Assessments one table 1 T1
xact-040 International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) Clinical Outcome Assessments one table 1 T1
xact-056 Patient Health Questionnaire–9 (PHQ-9) Clinical Outcome Assessments one table 1 T1
xact-057 Columbia-Suicide Severity Rating Scale (C-SSRS) Clinical Outcome Assessments one table 1 T1
xact-041 DEXA scan EFFICACY one table 1 T1
xact-042 SAFETY one table 1 T1 section
xact-043 Physical examination SAFETY one table 1 T1
xact-044 Pregnancy test SAFETY one table 1 T1
xact-045 ECG SAFETY one table 1 T1
xact-046 Adverse event SAFETY one table 1 T1
xact-047 Technical complaint SAFETY one table 1 T1
xact-048 Breast neoplasms follow-up SAFETY one table 1 T1
xact-049 Colon neoplasms follow-up SAFETY one table 1 T1
xact-050 Haematology SAFETY one table 1 T1
xact-051 Biochemistry SAFETY one table 1 T1
xact-052 Anti-Semaglutide Antibody SAFETY one table 1 T1
xact-053 Vital Signs SAFETY one table 1 T1
xact-055 Clinical Outcome Assessments SAFETY one table 1 T1
xact-058 OTHER ASSESSMENTS one table 1 T1 section
xact-059 Semaglutide plasma concentration OTHER ASSESSMENTS one table 1 T1
xact-060 Biosamples for future analysis OTHER ASSESSMENTS one table 1 T1
xact-061 TRIAL MATERIAL one table 1 T1 section
xact-062 First date on trial product TRIAL MATERIAL one table 1 T1
xact-063 IWRS session TRIAL MATERIAL one table 1 T1
xact-064 Administration of trial product TRIAL MATERIAL one table 1 T1
xact-065 Dispensing visit Administration of trial product one table 1 T1
xact-066 Drug accountability Administration of trial product one table 1 T1
xact-067 REMINDERS one table 1 T1 section
xact-068 Criteria for discontinuation REMINDERS one table 1 T1
xact-069 Barriers and motivation interview REMINDERS one table 1 T1
xact-070 Diet and physical activity counselling REMINDERS one table 1 T1
xact-071 Training in trial product, pen-handling REMINDERS one table 1 T1
xact-072 Hand out direction for use REMINDERS one table 1 T1
xact-073 Hand out dose reminder card REMINDERS one table 1 T1
xact-074 Hand out and instruct in food diary REMINDERS one table 1 T1
xact-075 Hand out and instruct in PK dairy REMINDERS one table 1 T1
xact-076 Collect, review and transcribe diaries REMINDERS one table 1 T1
xact-077 Hand out ID card REMINDERS one table 1 T1
xact-078 Attend visit fasting REMINDERS one table 1 T1
▼ Unified Annotations 37 annotations (0% dedup from 37)
Footnote (7)
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 | International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) (+1)
xannot-003 3 T1:c 1 Smoking is defined as smoking at least one cigarette or equivalent daily. Tobacco Use
xannot-004 4 T1:d 1 DEXA scan is performed in a sub-population. DEXA scan
xannot-005 5 T1:e 1 DEXA scan should be performed in fasting state prior to randomisation (after informed consent is obtained). DEXA scan 1 cells
xannot-006 6 T1:f 1 Only for subjects where the separate informed consent for future research has been signed. Biosamples for future analysis
xannot-007 7 T1:g 1 Fasting at V25 is defined as at least 2 hours without food and drink intake except water before attending the visit. Attend visit fasting 1 cells
Source Note (30)
xannot_idmarkers#textscopepoints to
xannot-008 8 T1:pr1 1 Appendix 3 Informed consent and Demography Appendix 3
xannot-009 9 T1:pr2 1 Appendix 5 Childbearing potential | Pregnancy test Appendix 5
xannot-010 10 T1:pr3 1 Section 6.1 Inclusion criteria Section 6.1
xannot-011 11 T1:pr4 1 Section 6.2 Exclusion criteria Section 6.2
xannot-012 12 T1:pr5 1 Section 6.3 Randomisation criteria and randomisation Section 6.3
xannot-013 13 T1:pr6 1 Section 9.4 Medical history/Concomitant illness | History of Gallbladder Disease | History of Breast Neoplasm (+5) Section 9.4
xannot-014 14 T1:pr7 1 Section 9 Weight History | Evaluation of lipid-lowering treatment | Evaluation of antihypertensive treatment (+6) Section 9
xannot-015 15 T1:pr8 1 Section 6.4.1 Tobacco Use | Attend visit fasting Section 6.4.1
xannot-016 16 T1:pr9 1 Section 7.7 Concomitant medication Section 7.7
xannot-017 17 T1:pr10 1 Section 7.1 Trial Product Compliance | Administration of trial product | Hand out dose reminder card Section 7.1
xannot-018 18 T1:pr11 1 Section 7.6 Trial Product Compliance Section 7.6
xannot-019 19 T1:pr12 1 Section 9.1.1 Body measurements Section 9.1.1
xannot-020 20 T1:pr13 1 Appendix 2 HbA1c | Fasting plasma glucose | Fasting serum insulin (+4) Appendix 2
xannot-021 21 T1:pr14 1 Section 9.8 Biomarkers Section 9.8
xannot-022 22 T1:pr15 1 Section 9.4.3 Vital Signs | Vital Signs Section 9.4.3
xannot-023 23 T1:pr16 1 Section 9.1.2 Clinical Outcome Assessments Section 9.1.2
xannot-024 24 T1:pr17 1 Section 9.4.2 Physical examination Section 9.4.2
xannot-025 25 T1:pr18 1 Section 9.4.5 Pregnancy test Section 9.4.5
xannot-026 26 T1:pr19 1 Section 9.4.4 ECG Section 9.4.4
xannot-027 27 T1:pr20 1 Section 9.2 Adverse event Section 9.2
xannot-028 28 T1:pr21 1 Appendix 4 Adverse event | Technical complaint Appendix 4
xannot-029 29 T1:pr22 1 Section 9.2.9 Technical complaint Section 9.2.9
xannot-030 30 T1:pr23 1 Section 9.4.6 Anti-Semaglutide Antibody Section 9.4.6
xannot-031 31 T1:pr24 1 Section 9.4.1 Clinical Outcome Assessments | Patient Health Questionnaire–9 (PHQ-9) | Columbia-Suicide Severity Rating Scale (C-SSRS) Section 9.4.1
xannot-032 32 T1:pr25 1 Section 9.5 Semaglutide plasma concentration Section 9.5
xannot-033 33 T1:pr26 1 Appendix 7 Biosamples for future analysis Appendix 7
xannot-034 34 T1:pr27 1 Section 7.5 Administration of trial product Section 7.5
xannot-035 35 T1:pr28 1 Section 8.1 Criteria for discontinuation Section 8.1
xannot-036 36 T1:pr29 1 Section 7.1.2 Diet and physical activity counselling Section 7.1.2
xannot-037 37 T1:pr30 1 Section 7.1.1 Training in trial product, pen-handling | Hand out direction for use Section 7.1.1