NCT04184622 — consolidated Schedule of Activities

usdm_data · 2 tables · 55 activities (41% compression) · 43 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
Near match across tables
Near match, different parent
| Annotations:
3 click for the text
 in Unified Annotations: show where it applies
| Cells:
Common
Prediabetes only
▼ Main Schedule (24 columns)
ActivityInTable 1
Visit1
[visit] L1		1232456789101112131415161718192021993ED48015
Week of Treatment
[week] L2		-2-104812162024283236404448525660646872724 wks Post TxP
Allowable Deviation (days)6
[window]		±3±3±3+7±3+7±3±3±3±3+7±3±3±3±3±3±3±3±3±7±7±3
Fasting Visit1
[visit_attribute]		XXXXXXXXXXXXXXXX
Telephone Visit
[modality]		XXXXXXXX
Informed consentT1X
RandomizationT1X
Register study visit in IWRST1,T2XXXXXXXXXXXXXXXXXXXXXXXX
Clinical AssessmentsT1,T2
Medical history7T1X
Physical examinationT1X
HeightT1X
Weight8T1,T2XXXXXXXXXXXXXXX
Waist circumferenceT1,T2XXXXXXXXXXXXXX
Electrocardiogram9T1,T2XXXXXXXX
Vital signs (3 sitting BP and HR)10T1,T2XXXXXXXXXXXXXX
Adverse events and product complaintsT1,T2XXXXXXXXXXXXXXXXXXXXXXXX
Concomitant medicationsT1,T2XXXXXXXXXXXXXXXXXXXXXXXX
Participant Education and AssessmentT1,T2
Hand out diary, instruct in use11T1,T2XXXXXXX
Review study participant diary, including study-drug compliance12T1,T2XXXXXXXXXXXXXXXXXXX
Lifestyle Program instructions13T1,T2XXXXXXXXXX
Review diet and exercise goals14T1,T2XXXXXXXXXXXXXXXXXXXX
Injection training with autoinjector demonstration device15T1X
Dispense study drugT1,T2XXXXXXXXXXX16
Observe participant administer study drug17T1X
Participant returns study drugs and injection suppliesT1,T2XXXXXXXXXXX
Laboratory TestsT1,T2
Serum pregnancy test18T1X
Urine pregnancy test19T1,T2XXXXXXXXX
Follicle-stimulating hormone test20T1X
2-hour oral glucose tolerance test (includes glucose, insulin, c-peptide at each timepoint)21T1,T2XXX
Chemistry panel (include Cr for eGFR calculation and glucose)23T1,T2XXXXXXXXXX
Lipid panelT1,T2XXXXXX
Fasting insulinT1XXXXXXXX
C-peptideT1XXXXXXXX
Free fatty acidsT1,T2XXXXXX
Urinary albumin/creatinineT1,T2X22XXXX
Cystatin-cT1,T2X22XXXX
CalcitoninT1,T2X22XXXXX
HematologyT1,T2X22XXXXX
HbA1cT1,T2XXXXXXXXXX
Pancreatic amylase, lipaseT1,T2XXXXXXX
Thyroid-stimulating hormoneT1X22
Immunogenicity (includes PK sample)24T1,T2XXXXXXXX
TZP PK25T1XXX
Pharmacogenetic stored sampleT1X
Nonpharmacogenetic stored sampleT1,T2XXXXXXX
Mental Health QuestionnairesT1,T2
PHQ-926T1,T2XXXXXXXXXXX
C-SSRS (Baseline/Screening) Version)26T1X
C-SSRS (Since Last Visit Version)26T1,T2XXXXXXXXXXXXXXXXXXXXXXX
Self-Harm Supplement Form26T1,T2XXXXXXXXXXXXXXXXXXXXXXXX
Self-Harm Follow-up Form27T1,T2XXXXXXXXXXXXXXXXXXXXXXXX
Patient Reported OutcomesT1
PGIST1,T2XXX
SF-36, version 2, acute formT1,T2XXX
IWQOL-Lite CTT1,T2XXX
EQ-5D-5LT1,T2XXX
PROsT2
▼ Track Timelines: Prediabetes (19 columns)
ActivityInTable 2
PrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetesPrediabetes
Visit1
[visit] L1		1011021031041051061071081091101111121131141151161993ED48025
Week of Treatment
[week] L2		7885919810411111712413013714315015616316917617617 wks Post TxP
Telephone Visit
[modality]		XXXXXXXX
Fasting Visit1
[visit_attribute]		XXXXXXXXXXX
Allowable Deviation (days)6
[window]		±7±7±7±7±7±7±7±7±7±7±7±7±7±7±7±7±7±3
Register study visit in IWRST1,T2XXXXXXXXXXXXXXXXXXX
Clinical AssessmentsT1,T2
Weight8T1,T2XXXXXXXXXXX
Waist circumferenceT1,T2XXXXXXXXXXX
Electrocardiogram9T1,T2XXXX
Vital signs (3 sitting BP and HR)10T1,T2XXXXXXXXXX
Adverse events and product complaintsT1,T2XXXXXXXXXXXXXXXXXXX
Concomitant medicationsT1,T2XXXXXXXXXXXXXXXXXXX
Participant Education and AssessmentT1,T2
Hand out diary, instruct in use11T1,T2XXXXXXX
Review study participant diary, including study-drug compliance12T1,T2XXXXXXXXXXXXXXXXX
Lifestyle Program instructions13T1,T2XXXXXXXXX
Review diet and exercise goals14T1,T2XXXXXXXXXXXXXXXXX
Dispense study drugT1,T2XXXXXXX
Participant returns study drugs and injection suppliesT1,T2XXXXXXXXX
Laboratory TestsT1,T2
Urine pregnancy test19T1,T2XXXXXXXXX
2-hour oral glucose tolerance test (includes glucose, insulin, c-peptide at each timepoint)21T1,T2XXXXX
Chemistry panel (include Cr for eGFR calculation and glucose)23T1,T2XXXXXXXXXX
Lipid panelT1,T2XXXX
Free fatty acidsT1,T2XXXX
Urinary albumin/creatinineT1,T2XXXX
Cystatin-cT1,T2XXXX
CalcitoninT1,T2XXXX
HematologyT1,T2XXXX
HbA1cT1,T2XXXXXXXXXX
Pancreatic amylase, lipaseT1,T2XXXX
Immunogenicity (includes PK sample)24T1,T2XXXXXX
Nonpharmacogenetic stored sampleT1,T2XXXX
Mental Health QuestionnairesT1,T2
PHQ-926T1,T2XXXXXXXXXXX
C-SSRS (Since Last Visit Version)26T1,T2XXXXXXXXXXXXXXXXXXX
Self-Harm Supplement Form26T1,T2XXXXXXXXXXXXXXXXXXX
Self-Harm Follow-up Form27T1,T2XXXXXXXXXXXXXXXXXXX
Patient Reported OutcomesT1
PGIST1,T2XXX
SF-36, version 2, acute formT1,T2XXX
IWQOL-Lite CTT1,T2XXX
EQ-5D-5LT1,T2XXX
PROsT2
▼ Matches across tables all 7 decided
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 NCT04184622_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.
staterowconsolidationother rowactivitydecision
decided · ccorr-001 keep T2 act-007 Adverse events/Product Complaints merged with 0.92 T1 act-012 Adverse events and product complaints xact-012 '/' for 'and'; same row. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-002 keep T2 act-011 Review study participant diary, including study drug compliance merged with 1.00 T1 act-016 Review study participant diary, including study-drug compliance xact-016 Hyphen only; the same note n12 on both rows. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-003 keep T2 act-018 2 hour oral glucose tolerance test (includes glucose, insulin, c-peptide) merged with 1.00 T1 act-027 2-hour oral glucose tolerance test (includes glucose, insulin, c-peptide at each timepoint) xact-027 Same test; the same note n21 on both rows. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-004 keep T2 act-019 Chemistry panel (includes Cr for eGFR calculation and glucose) merged with 1.00 T1 act-028 Chemistry panel (include Cr for eGFR calculation and glucose) xact-028 'includes' for 'include'; the same note n23 on both rows. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-005 keep T2 act-022 Urinary albumin/creatinine ratio merged with 0.90 T1 act-033 Urinary albumin/creatinine xact-033 Same row; Table 2 adds the word 'ratio'. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-006 keep T2 act-037 SF-36, version 2 acute merged with 0.90 T1 act-052 SF-36, version 2, acute form xact-052 Same instrument; the parent 'PROs' is 'Patient Reported Outcomes' abbreviated. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-007 keep T2 act-038 IWQOL-Lite -CT merged with 1.00 T1 act-053 IWQOL-Lite CT xact-053 Hyphen only; the parent 'PROs' is 'Patient Reported Outcomes' abbreviated. Kerstin Forsberg, 2026-10-04T08:20:00Z
Draft — entries to append to consolidated/NCT04184622_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-04T08:21:20.242337+00:00
source_activity_count93
unified_activity_count55
compression_percent41
match_statsexact: 31, fuzzy_auto: 5, fuzzy_cross_parent: 2, new: 55
▼ Source Tables 2 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Schedule of Activities covering visits to primary study endpoint
Main 72-week treatment schedule (screening, treatment to primary endpoint at Week 72, Visit 99, early discontinuation and safety follow-up Visit 801) for all participants.		 54 24 5
T2 track Prediabetes Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization
Additional 2-year treatment period (Weeks 78-176, Visits 101-116, 199, ED, 802) for participants with prediabetes at randomization only.		 39 19 5
▼ Unified Activities 55 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Informed consent one table 1 T1
xact-002 Randomization one table 1 T1
xact-003 Register study visit in IWRS same name 2 T1, T2
xact-004 Clinical Assessments same name 2 T1, T2 section
xact-005 Medical history Clinical Assessments one table 1 T1
xact-006 Physical examination Clinical Assessments one table 1 T1
xact-007 Height Clinical Assessments one table 1 T1
xact-008 Weight Clinical Assessments same name 2 T1, T2
xact-009 Waist circumference Clinical Assessments same name 2 T1, T2
xact-010 Electrocardiogram Clinical Assessments same name 2 T1, T2
xact-011 Vital signs (3 sitting BP and HR) Clinical Assessments same name 2 T1, T2
xact-012 Adverse events and product complaints
≈ Adverse events/Product Complaints		 Clinical Assessments near match, accepted 2 T1, T2
xact-013 Concomitant medications Clinical Assessments same name 2 T1, T2
xact-014 Participant Education and Assessment same name 2 T1, T2 section
xact-015 Hand out diary, instruct in use Participant Education and Assessment same name 2 T1, T2
xact-016 Review study participant diary, including study-drug compliance
≈ Review study participant diary, including study drug compliance		 Participant Education and Assessment near match, accepted 2 T1, T2
xact-017 Lifestyle Program instructions Participant Education and Assessment same name 2 T1, T2
xact-018 Review diet and exercise goals Participant Education and Assessment same name 2 T1, T2
xact-019 Injection training with autoinjector demonstration device Participant Education and Assessment one table 1 T1
xact-020 Dispense study drug Participant Education and Assessment same name 2 T1, T2
xact-021 Observe participant administer study drug Participant Education and Assessment one table 1 T1
xact-022 Participant returns study drugs and injection supplies Participant Education and Assessment same name 2 T1, T2
xact-023 Laboratory Tests same name 2 T1, T2 section
xact-024 Serum pregnancy test Laboratory Tests one table 1 T1
xact-025 Urine pregnancy test Laboratory Tests same name 2 T1, T2
xact-026 Follicle-stimulating hormone test Laboratory Tests one table 1 T1
xact-027 2-hour oral glucose tolerance test (includes glucose, insulin, c-peptide at each timepoint)
≈ 2 hour oral glucose tolerance test (includes glucose, insulin, c-peptide)		 Laboratory Tests near match, accepted 2 T1, T2
xact-028 Chemistry panel (include Cr for eGFR calculation and glucose)
≈ Chemistry panel (includes Cr for eGFR calculation and glucose)		 Laboratory Tests near match, accepted 2 T1, T2
xact-029 Lipid panel Laboratory Tests same name 2 T1, T2
xact-030 Fasting insulin Laboratory Tests one table 1 T1
xact-031 C-peptide Laboratory Tests one table 1 T1
xact-032 Free fatty acids Laboratory Tests same name 2 T1, T2
xact-033 Urinary albumin/creatinine
≈ Urinary albumin/creatinine ratio		 Laboratory Tests near match, accepted 2 T1, T2
xact-034 Cystatin-c Laboratory Tests same name 2 T1, T2
xact-035 Calcitonin Laboratory Tests same name 2 T1, T2
xact-036 Hematology Laboratory Tests same name 2 T1, T2
xact-037 HbA1c Laboratory Tests same name 2 T1, T2
xact-038 Pancreatic amylase, lipase Laboratory Tests same name 2 T1, T2
xact-039 Thyroid-stimulating hormone Laboratory Tests one table 1 T1
xact-040 Immunogenicity (includes PK sample) Laboratory Tests same name 2 T1, T2
xact-041 TZP PK Laboratory Tests one table 1 T1
xact-042 Pharmacogenetic stored sample Laboratory Tests one table 1 T1
xact-043 Nonpharmacogenetic stored sample Laboratory Tests same name 2 T1, T2
xact-044 Mental Health Questionnaires same name 2 T1, T2 section
xact-045 PHQ-9 Mental Health Questionnaires same name 2 T1, T2
xact-046 C-SSRS (Baseline/Screening) Version) Mental Health Questionnaires one table 1 T1
xact-047 C-SSRS (Since Last Visit Version) Mental Health Questionnaires same name 2 T1, T2
xact-048 Self-Harm Supplement Form Mental Health Questionnaires same name 2 T1, T2
xact-049 Self-Harm Follow-up Form Mental Health Questionnaires same name 2 T1, T2
xact-050 Patient Reported Outcomes one table 1 T1 section
xact-051 PGIS Patient Reported Outcomes same name 2 T1, T2
xact-052 SF-36, version 2, acute form
≈ SF-36, version 2 acute		 Patient Reported Outcomes / PROs near match, different parent 2 T1, T2
xact-053 IWQOL-Lite CT
≈ IWQOL-Lite -CT		 Patient Reported Outcomes / PROs near match, different parent 2 T1, T2
xact-054 EQ-5D-5L Patient Reported Outcomes same name 2 T1, T2
xact-055 PROs one table 1 T2 section
▼ Unified Annotations 27 annotations (40% dedup from 45)
Footnote (27)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1-2:n1 2 On all office visits, study participants should be reminded to report to the site before taking study drug (s) in a fasting condition, after a period of approximately 8 hours without eating, drinking (except water), or any significant physical activity. Since some screening procedures need to be completed in the fasting state, Visit 1 may be conducted over more than 1 day to ensure necessary conditions are met. Visit | Fasting Visit
xannot-002 2 T1:n2 1 Baseline assessments must be completed before processing in the IWRS. 3
xannot-003 3 T1-2:n3 2 Participants wanting to discontinue the study before Week 72 will be asked to return for Visit 99 at 72 weeks ± 7 days after randomization primarily for body weight measurement and assessment of adverse events. If the participant is unwilling to attend Visit 99, it should be documented in the participant medical record that the participant has refused to attend. Participants wanting to discontinue the study after Week 72 but before Week 176 will be asked to return for Visit 199 primarily for the body weight measurement and assessment of adverse events. Refusal to attend should be documented. 99 | 199
xannot-004 4 T1-2:n4 2 Participants who are unable or unwilling to continue the study treatment for any reason will perform an ED visit. If the participant is discontinuing during an unscheduled visit or a scheduled visit, that visit should be performed as the ED visit. ED | ED
xannot-005 5 T1-2:n5 2 For participants who discontinue or complete the study within the first 72 weeks, Visit 801 (safety follow-up visit) should be performed 4 weeks after the last visit during the 72-week treatment period. Participants with prediabetes continuing to Week 78 should not perform Visit 801. For participants with prediabetes who complete the 176 weeks or discontinue after Week 72, Visit 802 should be performed 17 weeks after the last visit during the additional 2-year treatment period for participants with prediabetes at randomization. 801 | 802
xannot-006 6 T1-2:n6 2 The visit date is determined in relation to the date of the randomization visit (± the allowed visit window). Allowable Deviation (days)
xannot-007 7 T1:n7 1 Medical history includes assessment of preexisting conditions (for example, history of gallbladder disease, cardiovascular disease, and medullary thyroid carcinoma) and substance usage (such as alcohol and tobacco). Medical history
xannot-008 8 T1-2:n8 2 Weight measurements should be obtained per the instructions in Section 10.7. Body weight must be measured in fasting state. If the participant is not fasting, the participant should be called in for a new visit within the visit window to have the fasting body weight measured. Weight Section 10.7
xannot-009 9 T1-2:n9 2 ECG measurements should be obtained per the instructions in Section 10.7. ECGs will be performed in triplicate at Weeks 0 and 36. All other ECGs will be single measurements. ECGs should be collected at least 30 minutes prior to collection of blood samples for laboratory testing, including PK samples. Electrocardiogram Section 10.7
xannot-010 10 T1-2:n10 2 Vital-sign measurements should be taken before obtaining an ECG tracing and before collection of blood samples for laboratory testing, per the instruction in Section 10.7. Vital signs (3 sitting BP and HR) Section 10.7
xannot-011 11 T1-2:n11 2 All training should be repeated as needed to ensure participant compliance. Hand out diary, instruct in use
xannot-012 12 T1-2:n12 2 Data from diary, as well as study drug compliance, should be reviewed. Review study participant diary, including study-drug compliance
xannot-013 13 T1-2:n13 2 Counselling on diet and exercise, to be performed by a dietician or equivalent qualified delegate, to include calculation of individualized energy requirement and methods to change dietary composition and amount of physical activity. The Lifestyle Program Instruction may be delivered on a separate day from the rest of that visit’s study procedures but must occur within the visit window. Beginning at Week 8, the Lifestyle Program Instruction may be delivered by phone. Lifestyle Program instructions
xannot-014 14 T1-2:n14 2 All training should be repeated as needed to ensure participant compliance. Study personnel to provide reinforcement and encouragement for lifestyle modifications. Review diet and exercise goals
xannot-015 15 T1:n15 1 All training should be repeated as needed to ensure participant compliance Injection training with autoinjector demonstration device
xannot-016 16 T1:n16 1 This applies only to those participants going into the additional 2-year treatment period for participants with prediabetes at randomization. Dispense study drug 1 cells
xannot-017 17 T1:n17 1 Participants should administer their first dose of study drug at the end of the Visit 3, after other study procedures are completed Observe participant administer study drug
xannot-018 18 T1:n18 1 A serum pregnancy test will be performed at Visit 1 for women of childbearing potential only. Serum pregnancy test
xannot-019 19 T1-2:n19 2 A urine pregnancy test must be performed at Visit 3 with the result available prior to randomization and first injection of study drug(s) for women of childbearing potential only. Additional pregnancy tests (beyond those required per the Schedule of Activities) should be performed at any time during the trial if a menstrual period is missed, there is clinical suspicion of pregnancy, or as required by local law or regulation. Urine pregnancy test
xannot-020 20 T1:n20 1 Follicle-stimulating hormone test performed at Visit 1 for postmenopausal women at least 40 years of age with an intact uterus, not on hormone therapy, and who have had spontaneous amenorrhea for more than 1 year without an alternative medical cause. Follicle-stimulating hormone test
xannot-021 21 T1-2:n21 2 2-hour OGTT testing should be omitted at visits following a protocol-defined diabetes diagnosis. 2-hour oral glucose tolerance test (includes glucose, insulin, c-peptide at each timepoint)
xannot-022 22 T1:n22 1 Screening visit assessment will be used to confirm eligibility. If calcitonin results are not available, a final review of eligibility will occur at Visit 3 before randomization can proceed. Urinary albumin/creatinine | Cystatin-c | Calcitonin (+2) 5 cells
xannot-023 23 T1-2:n23 2 The CKD-EPI equation will be used by the central lab to estimate and report eGFR. Chemistry panel (include Cr for eGFR calculation and glucose)
xannot-024 24 T1-2:n24 2 PK samples for immunogenicity must be taken prior to drug administration at these visits. In the event of systemic drug hypersensitivity reactions (immediate or nonimmediate), additional blood samples will be collected including ADA, PK, and exploratory biomarker samples. Immunogenicity (includes PK sample)
xannot-025 25 T1:n25 1 PK samples will be collected at these visits at time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose, as assigned by IWRS at randomization. Dependent on the time windows to which a participant is assigned, they may be required to come to site for PK-specific visits. TZP PK
xannot-026 26 T1-2:n26 2 The C-SSRS, Self-Harm Supplement Form and PHQ-9 should be administered after assessment of adverse events. For this study, the C-SSRS is adapted for the assessment of the ideation and behavior categories only. The Intensity of Ideation and Lethality of Behavior sections are removed. PHQ-9 | C-SSRS (Baseline/Screening) Version) | C-SSRS (Since Last Visit Version) (+1)
xannot-027 27 T1-2:n27 2 Self-Harm Follow-up Form is only required if triggered by the Self-Harm Supplement Form, per instructions in the form. Self-Harm Follow-up Form