NCT03693430 — consolidated Schedule of Activities

usdm_data · 1 tables · 63 activities (0% compression) · 34 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
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Near match, different parent
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Common
▼ Main Schedule (34 columns)
ActivityInTable 1
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 periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodMaintenance periodEnd of treatment31End of trial
Visit (V), Phone(P)
[visit] L2		V1V2P3V4P5V6P7V8P9V10P11V12P13V14P15V16P17V18P19V20P21V22P23V24P25V26P27V28P29V30P31V32V33V34
Timing of Visit (Weeks)
[week] L3		-10246810121416182024283236404448525660646872768084889296100104111
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±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
Randomisation criteria and randomisation9T1X
Medical history/Concomitant illness10T1X
Weight History11T1X
History of Gallbladder Disease10T1X
History of Breast Neoplasm2,10T1X
History of Colon Neoplasm10T1X
History of Skin Cancer10T1X
History of Psychiatric disorder10T1X
Tobacco use3T1X
Concomitant medication12T1XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Trial product compliance13,14T1XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Evaluation of lipid-lowering treatment11T1XXXX
Evaluation of antihypertensive treatment11T1XXXX
Evaluation of glycaemic status11T1XXXXX
EFFICACYT1
Body measurements15T1
HeightT1X
Body weightT1XXXXXXXXXXXXXXXXXXX
Waist circumferenceT1XXXXXXXXXXXXXXXXXX
HbA1c16T1XXXXXX
Fasting plasma glucose16T1XXXXX
Fasting serum insulin16T1XX
Lipids16T1XXXXX
Biomarkers16T1XXXXX
Vital signs17T1
Systolic Blood PressureT1XXXXXXXXXXXXXXXXXXX
Diastolic Blood PressureT1XXXXXXXXXXXXXXXXXXX
Control of Eating Questionnaire (CoEQ)4,18T1xxxx
SAFETYT1
Physical examination19T1XXX
Pregnancy test2,6,20T1XXXXXXXXXXXXXXXXXXX
ECG21T1XXXXX
Adverse event22,23T1XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Technical complaint23,24T1XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Breast neoplasms follow-up2,10T1XX
Colon neoplasms follow-up10T1XX
Haematology16T1XXXXX
Biochemistry16T1XXXXX
Vital Signs17T1
PulseT1XXXXXXXXXXXXXXXXXXX
Patient Health Questionnaire– 9 (PHQ-9)25T1XXXXXXXXX
Columbia Suicide Severity Rating Scale (C-SSRS)25T1XXXXXXXXX
TRIAL MATERIALT1
First date on trial productT1X
IWRS sessionT1XXXXXXXXXXXXXXXX
Administration of trial product13,26T1
Dispensing visitT1XXXXXXXXXXXXXX
Drug accountabilityT1XXXXXXXXXXXXXXX
REMINDERST1
Criteria for discontinuation27T1XXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Barriers and motivation interview11T1X
Diet and physical activity counselling28T1XXXXXXXXXXXXXXXXXXXXXXXXXXX
Hand out directions for use29T1X
Training in trial product, pen-handling29T1XXXXXXXXXXXXXXXX
Hand out dose reminder card13T1XXXXX
Hand out and instruct in food diary11T1X
Hand out ID cardT1X
Attend visit fasting30T1XXXXX
▼ 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 NCT03693430_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/NCT03693430_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:32.674344+00:00
source_activity_count63
unified_activity_count63
compression_percent0
match_statsnew: 63
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Flowchart
Main schedule of activities: screening, randomisation, dose escalation, maintenance, end of treatment and end of trial		 63 34 4
▼ Unified Activities 63 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 EFFICACY one table 1 T1 section
xact-021 Body measurements EFFICACY one table 1 T1
xact-022 Height Body measurements one table 1 T1
xact-023 Body weight Body measurements one table 1 T1
xact-024 Waist circumference Body measurements one table 1 T1
xact-025 HbA1c EFFICACY one table 1 T1
xact-026 Fasting plasma glucose EFFICACY one table 1 T1
xact-027 Fasting serum insulin EFFICACY one table 1 T1
xact-028 Lipids EFFICACY one table 1 T1
xact-029 Biomarkers 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-033 Control of Eating Questionnaire (CoEQ) EFFICACY one table 1 T1
xact-034 SAFETY one table 1 T1 section
xact-035 Physical examination SAFETY one table 1 T1
xact-036 Pregnancy test SAFETY one table 1 T1
xact-037 ECG SAFETY one table 1 T1
xact-038 Adverse event SAFETY one table 1 T1
xact-039 Technical complaint SAFETY one table 1 T1
xact-040 Breast neoplasms follow-up SAFETY one table 1 T1
xact-041 Colon neoplasms follow-up SAFETY one table 1 T1
xact-042 Haematology SAFETY one table 1 T1
xact-043 Biochemistry SAFETY one table 1 T1
xact-044 Vital Signs SAFETY one table 1 T1
xact-045 Pulse Vital Signs one table 1 T1
xact-046 Patient Health Questionnaire– 9 (PHQ-9) SAFETY one table 1 T1
xact-047 Columbia Suicide Severity Rating Scale (C-SSRS) SAFETY one table 1 T1
xact-048 TRIAL MATERIAL one table 1 T1 section
xact-049 First date on trial product TRIAL MATERIAL one table 1 T1
xact-050 IWRS session TRIAL MATERIAL one table 1 T1
xact-051 Administration of trial product TRIAL MATERIAL one table 1 T1
xact-052 Dispensing visit Administration of trial product one table 1 T1
xact-053 Drug accountability Administration of trial product one table 1 T1
xact-054 REMINDERS one table 1 T1 section
xact-055 Criteria for discontinuation REMINDERS one table 1 T1
xact-056 Barriers and motivation interview REMINDERS one table 1 T1
xact-057 Diet and physical activity counselling REMINDERS one table 1 T1
xact-058 Hand out directions for use REMINDERS one table 1 T1
xact-059 Training in trial product, pen-handling REMINDERS one table 1 T1
xact-060 Hand out dose reminder card REMINDERS one table 1 T1
xact-061 Hand out and instruct in food diary REMINDERS one table 1 T1
xact-062 Hand out ID card REMINDERS one table 1 T1
xact-063 Attend visit fasting REMINDERS one table 1 T1
▼ Unified Annotations 31 annotations (0% dedup from 31)
Footnote (5)
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 | Pregnancy test (+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 Applicable for US and Canada only Control of Eating Questionnaire (CoEQ)
xannot-031 31 T1:n1 1 Reviewer note, not source content: the End of treatment (V33) visit window is printed as ±3 on pages 9-10 and as ±5 on the reprinted header of pages 11-12; ±3 (first printed) is recorded. The source is inconsistent and the protocol text available does not resolve it. V33
Source Note (26)
xannot_idmarkers#textscopepoints to
xannot-005 5 T1:pr1 1 See Appendix 3. Informed consent and Demography Appendix 3
xannot-006 6 T1:pr2 1 See Appendix 5. Childbearing potential | Pregnancy test Appendix 5
xannot-007 7 T1:pr3 1 See Section 6.1. Inclusion criteria Section 6.1
xannot-008 8 T1:pr4 1 See Section 6.2. Exclusion criteria Section 6.2
xannot-009 9 T1:pr5 1 See Section 6.3. Randomisation criteria and randomisation Section 6.3
xannot-010 10 T1:pr6 1 See Section 9.4. Medical history/Concomitant illness | History of Gallbladder Disease | History of Breast Neoplasm (+5) Section 9.4
xannot-011 11 T1:pr7 1 See Section 9. Weight History | Evaluation of lipid-lowering treatment | Evaluation of antihypertensive treatment (+3) Section 9
xannot-012 12 T1:pr8 1 See Section 7.7. Concomitant medication Section 7.7
xannot-013 13 T1:pr9 1 See Section 7.1. Trial product compliance | Administration of trial product | Hand out dose reminder card Section 7.1
xannot-014 14 T1:pr10 1 See Section 7.6. Trial product compliance Section 7.6
xannot-015 15 T1:pr11 1 See Section 9.1.1. Body measurements Section 9.1.1
xannot-016 16 T1:pr12 1 See Appendix 2. HbA1c | Fasting plasma glucose | Fasting serum insulin (+4) Appendix 2
xannot-017 17 T1:pr13 1 See Section 9.4.3. Vital signs | Vital Signs Section 9.4.3
xannot-018 18 T1:pr14 1 See Section 9.1.3. Control of Eating Questionnaire (CoEQ) Section 9.1.3
xannot-019 19 T1:pr15 1 See Section 9.4.2. Physical examination Section 9.4.2
xannot-020 20 T1:pr16 1 See Section 9.4.5. Pregnancy test Section 9.4.5
xannot-021 21 T1:pr17 1 See Section 9.4.4. ECG Section 9.4.4
xannot-022 22 T1:pr18 1 See Section 9.2. Adverse event Section 9.2
xannot-023 23 T1:pr19 1 See Appendix 4. Adverse event | Technical complaint Appendix 4
xannot-024 24 T1:pr20 1 See Section 9.2.9. Technical complaint Section 9.2.9
xannot-025 25 T1:pr21 1 See Section 9.4.1. Patient Health Questionnaire– 9 (PHQ-9) | Columbia Suicide Severity Rating Scale (C-SSRS) Section 9.4.1
xannot-026 26 T1:pr22 1 See Section 7.5. Administration of trial product Section 7.5
xannot-027 27 T1:pr23 1 See Section 8.1. Criteria for discontinuation Section 8.1
xannot-028 28 T1:pr24 1 See Section 7.1.2. Diet and physical activity counselling Section 7.1.2
xannot-029 29 T1:pr25 1 See Section 7.1.1. Hand out directions for use | Training in trial product, pen-handling Section 7.1.1
xannot-030 30 T1:pr26 1 See Section 6.4.1. Attend visit fasting Section 6.4.1