NCT01797120 · Consolidated SoA

Activities:

Near match across tables

Near match, different parent

| Annotations:

³ click for the text

in Unified Annotations: show where it applies

| Cells:

Common

▼ Main Schedule (8 columns)

Activity	In	Table 1
Phase [epoch] L1		Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)	Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)¹⁶	Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)	Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)¹⁶	Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)	End of Induction Phase <OR> End of Treatment^17,20	Continuation Phase (until progression or unacceptable toxicity)¹⁸	Follow-Up Off Therapy (every 3 months for total of 3 yrs from date of randomization)
Visit / Occasion [timepoint] L2		Pre-Study	Cycle 1 Day 1	Cycle 1 Day 15	Day 1 Each Subsequent Cycle	Every 12 weeks
Eligibility Assessment	T1	X¹
Informed Consent	T1	X
Medical History & Assessment of Baseline Signs and Symptoms	T1	X¹
Physical Exam	T1	X¹	X²	X	X³		X
Concomitant Meds¹⁹	T1	X¹	X²	X	X³		X
Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight	T1	X (includes Ht)¹	X²	X	X³		X
ECOG Performance Status	T1	X¹	X²	X	X³		X
Adverse Events Assessments	T1		X²	X	X³		X¹⁰	X¹⁰	X¹⁰
Imaging Scans	T1	X^1,9				X⁹	X⁹	X⁹	X^9,13,15
PT with INR	T1	X¹
Urinalysis	T1	X¹
CBC with differentials, Platelets	T1	X¹	X²	X⁴	X^3,4		X⁴	X¹¹
Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.	T1	X¹	X²	X	X³		X	X¹¹
Fasting Glucose	T1	X¹	X²		X⁵	X⁵	X⁵	X¹¹
Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)	T1	X¹	X²		X⁵	X⁵	X⁵	X¹¹
HBV-DNA, HbsAg, HBsAb, HBcAb, HCV-RNA-PCR	T1	X^1,6
HBV DNA	T1		X^6,7		X^6,7			X¹¹
HCV RNA-PCR	T1		X^6,8		X^6,8			X¹¹
Study Drug Compliance (Pill Diary)	T1			X	X		X	X¹²
PFTs with DLCO as medically indicated¹⁴	T1

Activity

Table 1

Phase
[epoch] L1

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)¹⁶

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)¹⁶

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)

End of Induction Phase <OR> End of Treatment^17,20

Continuation Phase (until progression or unacceptable toxicity)¹⁸

Follow-Up Off Therapy (every 3 months for total of 3 yrs from date of randomization)

Visit / Occasion
[timepoint] L2

Pre-Study

Cycle 1 Day 1

Cycle 1 Day 15

Day 1 Each Subsequent Cycle

Every 12 weeks

Eligibility Assessment

X¹

Informed Consent

Medical History & Assessment of Baseline Signs and Symptoms

X¹

Physical Exam

X¹

X²

X³

Concomitant Meds¹⁹

X¹

X²

X³

Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight

X (includes Ht)¹

X²

X³

ECOG Performance Status

X¹

X²

X³

Adverse Events Assessments

X²

X³

X¹⁰

Imaging Scans

X^1,9

X⁹

X^9,13,15

PT with INR

X¹

Urinalysis

X¹

CBC with differentials, Platelets

X¹

X²

X⁴

X^3,4

X⁴

X¹¹

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.

X¹

X²

X³

X¹¹

Fasting Glucose

X¹

X²

X⁵

X¹¹

Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

X¹

X²

X⁵

X¹¹

HBV-DNA, HbsAg, HBsAb, HBcAb, HCV-RNA-PCR

X^1,6

HBV DNA

X^6,7

X¹¹

HCV RNA-PCR

X^6,8

X¹¹

Study Drug Compliance (Pill Diary)

X¹²

PFTs with DLCO as medically indicated¹⁴

▼ 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 NCT01797120_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/NCT01797120_consolidation_corrections.json; replace each <why>, then re-run consolidation.

▼ Consolidation Metadata Process information

consolidated_at	2026-10-03T19:23:23.809698+00:00
source_activity_count	20
unified_activity_count	20
compression_percent	0
match_stats	new: 20

▼ Source Tables 1 tables

table	type	track	title / purpose	acts	cols	props
T1	main_soa		Study Parameters Main schedule of procedures from pre-study through induction, end of induction/treatment, continuation phase and follow-up off therapy	20	8	2

▼ Unified Activities 20 activities

xact_id	activity_name (variations)	match	#	tables
xact-001	Eligibility Assessment	one table	1	T1
xact-002	Informed Consent	one table	1	T1
xact-003	Medical History & Assessment of Baseline Signs and Symptoms	one table	1	T1
xact-004	Physical Exam	one table	1	T1
xact-005	Concomitant Meds	one table	1	T1
xact-006	Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight	one table	1	T1
xact-007	ECOG Performance Status	one table	1	T1
xact-008	Adverse Events Assessments	one table	1	T1
xact-009	Imaging Scans	one table	1	T1
xact-010	PT with INR	one table	1	T1
xact-011	Urinalysis	one table	1	T1
xact-012	CBC with differentials, Platelets	one table	1	T1
xact-013	Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.	one table	1	T1
xact-014	Fasting Glucose	one table	1	T1
xact-015	Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)	one table	1	T1
xact-016	HBV-DNA, HbsAg, HBsAb, HBcAb, HCV-RNA-PCR	one table	1	T1
xact-017	HBV DNA	one table	1	T1
xact-018	HCV RNA-PCR	one table	1	T1
xact-019	Study Drug Compliance (Pill Diary)	one table	1	T1
xact-020	PFTs with DLCO as medically indicated	one table	1	T1

▼ Unified Annotations 20 annotations (0% dedup from 20)

Footnote (18)

xannot_id	markers	#	text	scope	points to
xannot-001 1	T1:a	1	≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).	Eligibility Assessment \| Medical History & Assessment of Baseline Signs and Symptoms \| Physical Exam (+11) 14 cells
xannot-002 2	T1:b	1	≤ 7 days prior to the start of C1D1.	Physical Exam \| Concomitant Meds \| Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight (+6) 9 cells
xannot-003 3	T1:c	1	+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted.	Physical Exam \| Concomitant Meds \| Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight (+4) 7 cells
xannot-004 4	T1:d	1	In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of hematologic recovery.	CBC with differentials, Platelets 3 cells
xannot-005 5	T1:e	1	+/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of treatment.	Fasting Glucose \| Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) 6 cells
xannot-006 6	T1:f	1	All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a positive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or HBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment should continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.	HBV-DNA, HbsAg, HBsAb, HBcAb, HCV-RNA-PCR \| HBV DNA \| HCV RNA-PCR 5 cells	Section 7.1.1 · Table 5-3
xannot-007 7	T1:g	1	Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.	HBV DNA 2 cells	Table 5-4
xannot-008 8	T1:h	1	Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered ‘cured’) should have HCV RNA-PCR testing performed on ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be discontinued if HCV flare is confirmed according to the guidance in Table 5-5.	HCV RNA-PCR 2 cells	Table 5-5
xannot-009 9	T1:i	1	Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week (every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be repeated once disease progression is documented.	Imaging Scans 5 cells
xannot-010 10	T1:j	1	Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo) or until ≤ grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last dose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.	Adverse Events Assessments 3 cells
xannot-011 11	T1:k	1	CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per labeling guidelines.	CBC with differentials, Platelets \| Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid. \| Fasting Glucose (+3) 6 cells
xannot-012 12	T1:l	1	Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.	Study Drug Compliance (Pill Diary) 1 cells
xannot-013 13	T1:m	1	All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed during the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented progression.	Imaging Scans 1 cells
xannot-014 14	T1:n	1	PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).	PFTs with DLCO as medically indicated
xannot-015 15	T1:o	1	Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.	Imaging Scans 1 cells
xannot-016 16	T1:*	1	Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15 of the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.	Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) \| Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)
xannot-017 17	T1:^	1	End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.	End of Induction Phase <OR> End of Treatment
xannot-018 18	T1:£	1	Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination with everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.	Continuation Phase (until progression or unacceptable toxicity)

Source Note (2)

xannot_id	markers	#	text	scope	points to
xannot-019 19	T1:pr1	1	see Appendix C	Concomitant Meds	Appendix C
xannot-020 20	T1:pr2	1	Section 5.6	End of Induction Phase <OR> End of Treatment	Section 5.6

NCT01797120 — consolidated Schedule of Activities