NCT02107703 — consolidated Schedule of Activities

usdm_data · 2 tables · 38 activities (10% compression) · 11 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
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Extension period only
▼ Main Schedule (8 columns)
ActivityInTable 1
Study period
[epoch] L1		BaselineBaselinePatients on Study TreatmentPatients on Study TreatmentPatients on Study Treatment16Patients on Study Treatment16Postdiscontinuation Follow-Up1Postdiscontinuation Follow-Up1
Cycle
[cycle] L2		BLBL112 – 34 and Beyond (if Applicable)Short-Term Follow-UpLong-Term Follow-Up
Visit
[visit] L3		00112 – 34 and Beyond (if Applicable)801802 - 8XX
Relative day within a cycle
[study_day] L4		≤28≤14115±311
Approximate Duration (days)
[other]		28282828282830Variable
Duration (days)
[other]		28282828282830Variable
Study Entry /EnrollmentT1
Informed Consent Form signed18T1X17X17
Inclusion/Exclusion evaluation19T1X
Medical HistoryT1
Medical HistoryT1X
Historical illnesses20T1X
Habits assessment20T1X
Physical ExaminationT1
Height20T1X
Weight20T1XXXXXX
Vital Signs (Temp, BP, HR, RR)20T1XXXXXX
ECOG performance status21,22T1XXXXXX
Tumor AssessmentT1
Tumor measurement (palpable or visible)23T1X3X3X3X3X3X3
Radiologic imaging according to RECIST23,24T1X2X2X2X2X2X2
Bone Scintigraphy23,24T1X9X9X9X9X9
X-ray or CT scan with bone windows or MRI23,24T1X10X10X10X10X10X10
Survival Information25T1X4X4
Adverse Event Collection/CTCAE Grading26,38T1,T2X6X6X6X6X6X6X6
Concomitant Medications (with analgesics)27T1XXXXXX
Lab/Diagnostic TestsT1
Central hematology28T1XXXXXX
Central serum chemistry28T1XXXXXX
Local FSH and estradiol levels28T1X14
Local serum pregnancy test28T1X15
Central pharmacokinetic (PK) sampling29T1X13X13X13
Pharmacogenetic blood sample30T1X
Biomarker plasma sample31T1X
Local ECG32T1X5X5X5X5X5
Archived Tumor Sample33T1X8
Study DrugT1,T2
Fulvestrant Therapy34,40T1,T2Days 1 and 15 of Cycle 1, then Day 1 of Cycle 2 and beyond7Days 1 and 15 of Cycle 1, then Day 1 of Cycle 2 and beyond7Days 1 and 15 of Cycle 1, then Day 1 of Cycle 2 and beyond7Days 1 and 15 of Cycle 1, then Day 1 of Cycle 2 and beyond7
LY2835219 Therapy34,40T1,T2Every 12 hours on Days 1 through 28 of every cycle7Every 12 hours on Days 1 through 28 of every cycle7Every 12 hours on Days 1 through 28 of every cycle7Every 12 hours on Days 1 through 28 of every cycle7
Health OutcomesT1
BPI, EORTC QLQ-C30, EORTC BR23, EQ-5D 5L35T1X11X11X11X11
Skeletal-Related Events assessment35T1X12X12X12X12X12
Hospitalization36T1XXXX
Transfusion36T1XXXX
▼ Track Timelines: Extension period (3 columns)
ActivityInTable 2
Extension periodExtension periodExtension period
Study period
[epoch] L1		Patients on Study TreatmentPatients on Study TreatmentExtension Period Follow-Up37
Cycle
[cycle] L2		X-YX-YFollow-Up
Visit
[visit] L3		501-5XX501-5XX901
Relative day within a cycle
[study_day] L4		115
Duration (days)
[other]		282830
Study Entry /EnrollmentT1
Medical HistoryT1
Physical ExaminationT1
Tumor AssessmentT1
Adverse Event Collection/CTCAE Grading26,38T1,T2XX
Lab/Diagnostic TestsT1
Study DrugT1,T2
Fulvestrant Therapy34,40T1,T2Days 1 and 15 of Cycle 1, then Day 1 of Cycle 2 and beyond39Days 1 and 15 of Cycle 1, then Day 1 of Cycle 2 and beyond39
LY2835219 Therapy34,40T1,T2Daily every 12 hours39Daily every 12 hours39
Health OutcomesT1
▼ Matches across tables all 1 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 NCT02107703_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-001 Adverse Events Collection/CTCAE Grading merged with 1.00 T1 act-019 Adverse Event Collection/CTCAE Grading xact-019 Plural only; the same footnote text on both rows. Kerstin Forsberg, 2026-10-04T08:20:00Z
Draft — entries to append to consolidated/NCT02107703_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-04T08:21:16.633285+00:00
source_activity_count42
unified_activity_count38
compression_percent10
match_statsexact: 3, fuzzy_auto: 1, new: 38
▼ Source Tables 2 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Study Schedule, Protocol I3Y-MC-JPBL
Main study schedule: baseline, on-treatment cycles and postdiscontinuation follow-up		 38 8 5
T2 track Extension period Study Schedule for the extension period only, Protocol I3Y-MC-JPBL
Schedule for patients continuing study treatment in the extension period after study completion		 4 3 5
▼ Unified Activities 38 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Study Entry /Enrollment one table 1 T1 section
xact-002 Informed Consent Form signed Study Entry /Enrollment one table 1 T1
xact-003 Inclusion/Exclusion evaluation Study Entry /Enrollment one table 1 T1
xact-004 Medical History one table 1 T1 section
xact-005 Medical History Medical History one table 1 T1
xact-006 Historical illnesses Medical History one table 1 T1
xact-007 Habits assessment Medical History one table 1 T1
xact-008 Physical Examination one table 1 T1 section
xact-009 Height Physical Examination one table 1 T1
xact-010 Weight Physical Examination one table 1 T1
xact-011 Vital Signs (Temp, BP, HR, RR) Physical Examination one table 1 T1
xact-012 ECOG performance status Physical Examination one table 1 T1
xact-013 Tumor Assessment one table 1 T1 section
xact-014 Tumor measurement (palpable or visible) Tumor Assessment one table 1 T1
xact-015 Radiologic imaging according to RECIST Tumor Assessment one table 1 T1
xact-016 Bone Scintigraphy Tumor Assessment one table 1 T1
xact-017 X-ray or CT scan with bone windows or MRI Tumor Assessment one table 1 T1
xact-018 Survival Information one table 1 T1
xact-019 Adverse Event Collection/CTCAE Grading
≈ Adverse Events Collection/CTCAE Grading		 near match, accepted 2 T1, T2
xact-020 Concomitant Medications (with analgesics) one table 1 T1
xact-021 Lab/Diagnostic Tests one table 1 T1 section
xact-022 Central hematology Lab/Diagnostic Tests one table 1 T1
xact-023 Central serum chemistry Lab/Diagnostic Tests one table 1 T1
xact-024 Local FSH and estradiol levels Lab/Diagnostic Tests one table 1 T1
xact-025 Local serum pregnancy test Lab/Diagnostic Tests one table 1 T1
xact-026 Central pharmacokinetic (PK) sampling Lab/Diagnostic Tests one table 1 T1
xact-027 Pharmacogenetic blood sample Lab/Diagnostic Tests one table 1 T1
xact-028 Biomarker plasma sample Lab/Diagnostic Tests one table 1 T1
xact-029 Local ECG Lab/Diagnostic Tests one table 1 T1
xact-030 Archived Tumor Sample Lab/Diagnostic Tests one table 1 T1
xact-031 Study Drug same name 2 T1, T2 section
xact-032 Fulvestrant Therapy Study Drug same name 2 T1, T2
xact-033 LY2835219 Therapy Study Drug same name 2 T1, T2
xact-034 Health Outcomes one table 1 T1 section
xact-035 BPI, EORTC QLQ-C30, EORTC BR23, EQ-5D 5L Health Outcomes one table 1 T1
xact-036 Skeletal-Related Events assessment Health Outcomes one table 1 T1
xact-037 Hospitalization Health Outcomes one table 1 T1
xact-038 Transfusion Health Outcomes one table 1 T1
▼ Unified Annotations 40 annotations (2% dedup from 41)
Footnote (19)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:a 1 Short-term follow-up begins the day after the patient and the investigator agree that the patient will no longer continue study treatment and lasts approximately 30 days; the associated study procedures are performed once at the end of this period. Long-term follow-up begins the day after short-term follow-up is completed and continues until the patient’s death or overall study completion; the associated study procedures are performed approximately every 12 weeks (± 14 days) for the duration of this period. 801 | 802 - 8XX
xannot-002 2 T1:b 1 For patients with inoperable locally advanced breast cancer, MRI scan of the breast is performed locally at baseline (Day -28 to Day -1), between Day 1 and Day 7 of every second cycle beginning with Cycle 3 and continuing through Cycle 13, between Day 1 and Day 7 of every third cycle after Cycle 13, and within 14 days of clinical progression. For all patients, CT or MRI scan of the chest, abdomen, and pelvis is performed locally at baseline (Day -28 to Day -1), between Day 1 and Day 7 of every second cycle beginning with Cycle 3 and continuing through Cycle 13, between Day 1 and Day 7 of every third cycle after Cycle 13, and within 14 days of clinical progression. It is recommended that CT imaging of the abdomen and pelvis be performed with IV contrast whenever possible. If this is not feasible due to hypersensitivity or other conditions, then gadolinium-enhanced MRI is preferred. For patients with known serious allergic reactions to CT contrast material, a CT of the chest without contrast and gadolinium-enhanced MRI of the abdomen/pelvis are encouraged. For patients who discontinue study treatment without objectively measured progressive disease (PD), continue to evaluate tumor response approximately every 8 weeks for the first 12 months following randomization and thereafter approximately every 12 weeks by the same method used at baseline and throughout the study until the patient has objective disease progression or until study completion. After the patient has objective disease progression, radiologic tests are no longer required and the patient will continue with post-discontinuation follow-up until the patient’s death or overall study completion. Radiologic imaging according to RECIST 6 cells
xannot-003 3 T1:c 1 Visible tumor (such as skin lesions) should be documented by photography and each photographic image of the tumor should include a ruler. For patients who discontinue study treatment without objectively measured progressive disease (PD), continue to evaluate tumor response approximately every 8 weeks for the first 12 months following randomization and thereafter approximately every 12 weeks by the same method used at baseline and throughout the study until the patient has objective disease progression or until study completion. After the patient has objective disease progression, tumor assessments are no longer required and the patient will continue with post-discontinuation follow-up until the patient’s death or overall study completion. Tumor measurement (palpable or visible) 6 cells
xannot-004 4 T1:d 1 Survival information is collected at baseline and during both study treatment and postdiscontinuation follow-up. During Long-Term Follow-Up, survival information is collected approximately every 12 weeks for the duration of this period. Although preferable to collect during a clinic visit, survival information may be collected by contacting the patient or family directly (for example, via telephone). Long-Term Follow-up data collection may include anticancer therapies. Survival Information 2 cells
xannot-005 5 T1:e 1 A local ECG (no replicates required) should be obtained at baseline (Day -14 to Day -1), 2 to 4 hours after the LY dose on Cycle 1 Day 1, upon arrival at site but prior to fulvestrant dose on Cycle 1 Day 15, 2 to 4 hours after the LY dose on Cycle 4 Day 1, and at the short-term follow-up visit. Local ECG 5 cells
xannot-006 6 T1:f 1 Data on SAEs that occur before the end of trial will be stored in the collection database and the Lilly Safety System. During Long-Term Follow-Up, only SAEs that are related to study drugs or protocol procedures will be collected. All adverse events possibly related to study drugs or protocol procedures should be followed until they resolve, are no longer considered to be possibly related, become stable or return to baseline, the patient starts a new therapy, the patient expires, or the patient becomes lost to follow-up. The frequency of evaluation is determined according to the judgment of the investigator. Adverse Event Collection/CTCAE Grading 7 cells
xannot-007 7 T1:g 1 LY2835219 should be administered orally every 12 hours on Days 1 through 28 of each cycle; patients should not consume food beginning 1 hour before and ending 1 hour after taking LY2835219. Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1 to 2 minutes per injection) as two 250-mg injections, one in each buttock; however, for patients with moderate hepatic impairment (defined as Child-Pugh Class B), including any patient who develops moderate hepatic impairment during study treatment, fulvestrant 250 mg should be administered intramuscularly into the buttock slowly (1 to 2 minutes) as one 250-mg injection. Fulvestrant Therapy | LY2835219 Therapy 8 cells
xannot-008 8 T1:h 1 Formalin-fixed paraffin-embedded tumor tissue (either block or 15-20 unstained slides) should be requested at the time of randomization. However, if this sample is not available for a patient, it will not constitute a protocol deviation Archived Tumor Sample 1 cells
xannot-009 9 T1:i 1 Bone scintigraphy is performed locally at baseline (Day -28 to Day -1) for all patients. If available, prior bone scintigraphy (obtained as part of routine clinical care) within 45 days before Day 1 of Cycle 1 is also acceptable. Bone scintigraphy should be repeated for all patients between Day 1 and Day 7 of every sixth cycle beginning with Cycle 7, when complete response is identified in target disease, or when progression in bone is suspected. Importantly, RECIST v1.1 emphasizes that bone scintigraphy is not adequate to measure bone lesions; however, bone scintigraphy can be used to confirm the presence or disappearance of bone lesions. For patients who discontinue study treatment without objectively measured progressive disease (PD), continue to evaluate tumor response approximately every 6 months until the patient has objective disease progression or until study completion. After the patient has objective disease progression, bone scintigraphy is no longer required and the patient will continue with post-discontinuation follow-up until the patient’s death or overall study completion. Bone Scintigraphy 5 cells
xannot-010 10 T1:j 1 One or more of these studies [X-ray, CT scan with bone windows, or MRI] is performed locally at baseline (Day -28 to Day -1), between Day 1 and Day 7 of every second cycle beginning with Cycle 3 and continuing through Cycle 13, between Day 1 and Day 7 of every third cycle after Cycle 13, and within 14 days of clinical progression only for patients with bone lesions identified by bone scintigraphy at baseline. For patients with new lesions identified by post-baseline bone scintigraphy, targeted assessment by X-ray, CT scan with bone windows, or MRI will be performed to confirm findings. For patients who discontinue study treatment without objectively measured progressive disease (PD), continue to evaluate tumor response approximately every 8 weeks for the first 12 months following randomization and thereafter approximately every 12 weeks by the same method used at baseline and throughout the study until the patient has objective disease progression or until study completion. After the patient has objective disease progression, radiologic tests are no longer required and the patient will continue with post-discontinuation follow-up until the patient’s death or overall study completion. X-ray or CT scan with bone windows or MRI 6 cells
xannot-011 11 T1:k 1 mBPI-sf, EORTC QLQ-C30, EORTC QLQ-BR23 and EQ-5D 5L should be administered at baseline (Day -14 to Day -1), Cycle 2 Day 1, and then on Day 1 of every second cycle beginning with Cycle 3 and continuing through Cycle 13, on Day 1 of every third cycle after Cycle 13, and at Short-Term Follow-Up. Patients should complete these assessments before extensive interaction with site staff. BPI, EORTC QLQ-C30, EORTC BR23, EQ-5D 5L 4 cells
xannot-012 12 T1:l 1 Skeletal-Related Events include pathological fracture, spinal cord compression, radiation to bone, and surgery to bone. Skeletal-Related Events assessment 5 cells
xannot-014 14 T1:n 1 FSH and estradiol levels are required only for women age <60 years and amenorrheic for at least 12 months. Local FSH and estradiol levels 1 cells
xannot-015 15 T1:o 1 A serum pregnancy test is required only for patients receiving ovarian suppression with a GnRH agonist. Local serum pregnancy test 1 cells
xannot-016 16 T1:p 1 For Cycle 2 and beyond, the start of a cycle may be delayed up to 7 days for logistical reasons and up to 14 days to allow sufficient time for recovery from toxicity possibly related to a study drug. Refer to Section 9.4.1.1.2. 2 – 3 | 4 and Beyond (if Applicable) Section 9.4.1.1.2
xannot-017 17 T1:q 1 Informed Consent Form is signed within 28 days prior to randomization of study drug and prior to performance of any protocol-specific tests/procedures. Informed Consent Form signed 2 cells
xannot-037 37 T2:a 1 The extension period begins after study completion and ends at the end of trial. 901
xannot-038 38 T2:b 1 Data on SAEs that occur before the end of trial will be stored in the collection database and the Lilly safety system. Adverse Event Collection/CTCAE Grading
xannot-039 39 T2:c 1 LY2835219 should be administered every 12 hours on Days 1 through 28 of each cycle. Patients should not consume food beginning 1 hour before and ending hour after taking study drug. Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1 to 2 minutes per injection) as two 250-mg injections, one in each buttock; however, for patients with moderate hepatic impairment (defined as Child-Pugh Class B), including any patient who develops moderate hepatic impairment during study treatment, fulvestrant 250 mg should be administered intramuscularly into the buttock slowly (1 to 2 minutes) as one 250-mg injection. Fulvestrant Therapy | LY2835219 Therapy 4 cells
Source Note (21)
xannot_idmarkers#textscopepoints to
xannot-013 13 T1:m 1 See Pharmacokinetic Sampling Schedule (Attachment 7). Central pharmacokinetic (PK) sampling 3 cells Attachment 7
xannot-018 18 T1:pr1 1 Section 8.1 Informed Consent Form signed Section 8.1
xannot-019 19 T1:pr2 1 Section 7 Inclusion/Exclusion evaluation Section 7
xannot-020 20 T1:pr3 1 Section 12.2.3 Historical illnesses | Habits assessment | Height (+2) Section 12.2.3
xannot-021 21 T1:pr4 1 Section 7.1 ECOG performance status Section 7.1
xannot-022 22 T1:pr5 1 Attachment 4 ECOG performance status Attachment 4
xannot-023 23 T1:pr6 1 Section 10.1.1 Tumor measurement (palpable or visible) | Radiologic imaging according to RECIST | Bone Scintigraphy (+1) Section 10.1.1
xannot-024 24 T1:pr7 1 Attachment 5 Radiologic imaging according to RECIST | Bone Scintigraphy | X-ray or CT scan with bone windows or MRI Attachment 5
xannot-025 25 T1:pr8 1 Section 10.1 Survival Information Section 10.1
xannot-026 26 T1-2:pr9 2 Section 10.3 Adverse Event Collection/CTCAE Grading Section 10.3
xannot-027 27 T1:pr10 1 Section 9.6 Concomitant Medications (with analgesics) Section 9.6
xannot-028 28 T1:pr11 1 Attachment 2 Central hematology | Central serum chemistry | Local FSH and estradiol levels (+1) Attachment 2
xannot-029 29 T1:pr12 1 Attachment 7 Central pharmacokinetic (PK) sampling Attachment 7
xannot-030 30 T1:pr13 1 Section 10.4.2.2 Pharmacogenetic blood sample Section 10.4.2.2
xannot-031 31 T1:pr14 1 Section 10.4.2.3 Biomarker plasma sample Section 10.4.2.3
xannot-032 32 T1:pr15 1 Section 10.3.2.1 Local ECG Section 10.3.2.1
xannot-033 33 T1:pr16 1 Section 10.4.2.1 Archived Tumor Sample Section 10.4.2.1
xannot-034 34 T1:pr17 1 Section 9.1 Fulvestrant Therapy | LY2835219 Therapy Section 9.1
xannot-035 35 T1:pr18 1 Section 12.2.11 BPI, EORTC QLQ-C30, EORTC BR23, EQ-5D 5L | Skeletal-Related Events assessment Section 12.2.11
xannot-036 36 T1:pr19 1 Section 12.2.11.4 Hospitalization | Transfusion Section 12.2.11.4
xannot-040 40 T2:pr20 1 Section 8.1.2 Fulvestrant Therapy | LY2835219 Therapy Section 8.1.2