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 NCT01847274_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.
state
row
consolidation
other row
activity
decision
decided · ccorr-001 keep
T2 act-003 Medical, cancer, surgical, medication history
merged with 1.00
T1 act-003 Medical, surgical, cancer, medication history
Different tests: hematology, not coagulation. Kerstin Forsberg, 2026-10-04T08:20:00Z
Draft — entries to append to consolidated/NCT01847274_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation MetadataProcess information
consolidated_at
2026-10-04T08:21:15.903272+00:00
source_activity_count
60
unified_activity_count
31
compression_percent
48
match_stats
exact: 26, fuzzy_auto: 3, new: 31
▼ Source Tables3 tables
table
type
track
title / purpose
acts
cols
props
T1
main_soa
Schedule of Events – Main Study Main study schedule from screening through post-treatment assessments
28
9
2
T2
track
Food Effect Sub-Study
Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed) Schedule for patients in the open-label food effect sub-study
17
8
3
T3
track
Extended Visit Cycle
Schedule of Events – Main Study –Extended Visit Cycle Alternative subsequent-cycle visit schedule (extended in-clinic cycle with telephone and local-clinic/in-home contacts)
15
5
3
▼ Unified Activities31 activities
xact_id
activity_name (variations)
parent
match
#
tables
row kind
xact-001
Informed Consent
same name
2
T1, T2
xact-002
Demographics
same name
2
T1, T2
xact-003
Medical, surgical, cancer, medication history ≈ Medical, cancer, surgical, medication history
near match, accepted
2
T1, T2
xact-004
Record local gBRCA mutation result, if done
one table
1
T1
xact-005
Blood sample for centralized gBRCA mutation testing
one table
1
T1
xact-006
Blood sample for DNA repair typing
one table
1
T1
xact-007
Pregnancy test
same name
2
T1, T2
xact-008
Randomization
same name
2
T1, T2
xact-009
Physical examination
same name
3
T1, T2, T3
xact-010
Vital signs, height, weight ≈ Vital signs, weight
near match, accepted
3
T1, T2, T3
xact-011
ECOG performance status
same name
3
T1, T2, T3
xact-012
Adverse event monitoring
same name
3
T1, T2, T3
xact-013
Concomitant medications
same name
3
T1, T2, T3
xact-014
Coagulation/serum chemistry ≈ Serum chemistry
near match, accepted
2
T1, T3
xact-015
CBC
same name
2
T1, T3
xact-016
Serum CA-125
same name
2
T1, T3
xact-017
Urinalysis
same name
2
T1, T2
xact-018
12-lead ECG
same name
3
T1, T2, T3
xact-019
Triplicate ECGs (selected sites only)
one table
1
T1
xact-020
Tumor sample
one table
1
T1
xact-021
Blood sample for PK
same name
2
T1, T2
xact-022
Tumor Assessment (RECIST)
same name
2
T1, T3
xact-023
Chest CT/MRI
one table
1
T1
xact-024
FOSI, EQ-5D-5L, neuropathy questionnaire
same name
2
T1, T3
xact-025
Study treatment dispensed/collected
same name
3
T1, T2, T3
xact-026
Anti-cancer therapies assessment
one table
1
T1
xact-027
Survival assessment
same name
2
T1, T3
xact-028
Bone marrow aspirate and biopsy
same name
3
T1, T2, T3
xact-029
Consumption of high fat meal, as applicable
one table
1
T2
xact-030
Hematology/serum chemistry
one table
1
T2
xact-031
Anticancer therapies assessment
one table
1
T3
▼ Unified Annotations52 annotations (9% dedup from 57)
Footnote (52)
xannot_id
markers
#
text
scope
points to
xannot-001 1
T1-2:1
2
Treatment cycles are 28 days long, visits on Day 1 of each cycle unless otherwise specified.
C1 | C1 | C2Cycle
xannot-002 2
T1-2:2
2
Visits continue every 4 weeks until study treatment discontinuation.
Subsequent Cycles | Cycle n, Day 1
xannot-003 3
T1:3
1
C1/D1 is day of first dose.
1
xannot-004 4
T1:4
1
A separate ICF may be signed prior to the screening period for Myriad Integrated BRACAnalysis® testing in order to facilitate early testing. Depending on local site requirements, patients may sign a single study ICF prior to the screening period to facilitate early gBRCAmut testing only. All other study tests and procedures must be done in the screening window (Day -28 to Day -1).
Informed Consent
xannot-005 5
T1:5
1
Local gBRCAmut results that had been performed previously should be entered into eCRF at screening.
Record local gBRCA mutation result, if done
xannot-006 6
T1:6
1
Centralized gBRCAmut testing of DNA by Integrated BRACAnalysis® at Myriad must be completed prior to randomization. The sample may be submitted prior to the screening period for patients who are identified for a Screening Visit to occur. DNA from this sample will be stored and may be used at a later time for biomarker testing including potential to bridging to candidate companion diagnostic assays.
Blood sample for centralized gBRCA mutation testing1 cells
xannot-007 7
T1:7
1
Negative serum pregnancy test required within 72 hours from first dose of study treatment for females of childbearing potential; repeated every 3 months for duration of study (ie, Cycle 4, Cycle 7, etc).
Pregnancy test2 cells
xannot-008 8
T1:8
1
Randomization must occur within 72 hours prior to first dose.
Randomization1 cells
xannot-009 9
T1:9, T2:7
2
Height obtained at screening only.
Vital signs, height, weight
xannot-010 10
T1:10, T2:14
2
SAEs recorded up to 30 days after study treatment discontinuation.
Adverse event monitoring2 cells
xannot-011 11
T1:11
1
If Screening laboratory testing (serum chemistry, CBC, coagulation) performed within 72 hours of Day 1, repeat testing not required.
Coagulation/serum chemistry1 cells
xannot-012 12
T1:12
1
If dose interruption or modification is required at any point on study because of hematologic toxicity, weekly blood draws for CBC will be monitored until the adverse event resolves, and to ensure safety of the new dose, weekly blood draws for CBC will be also be required for an additional 4 weeks after the adverse event has been resolved to the specified levels, after which monitoring every 4 weeks may resume.
CBC
xannot-013 13
T1:13
1
CA-125 levels must be normal at screening or > 90% decrease as compared with baseline prior to last platinum-based chemotherapy course. Abnormal CA-125 levels during study do not represent disease progression; however, they may prompt imaging if clinically indicated. CA-125 sample within 72 hours of dose on Cycle 1/Day 1.
Serum CA-125
xannot-014 14
T1:14
1
For determination of CA-125 progression, at least 2 CA-125 values at least 1 week apart are required for confirmation (Section 6.1).
Serum CA-125
Section 6.1
xannot-015 15
T1:15
1
Urinalysis parameters must include: specific gravity, leukocyte esterase, nitrite, blood, protein, glucose, ketones, urobilinogen, and bilirubin.
Urinalysis
xannot-016 16
T1:16
1
Patients will have a 12-lead ECG at Screening, Baseline (predose, within 30 minutes), 2 hours postdose on Day 1(within 30 minutes), Cycle 2/Day 1, (predose, 2 hours postdose, within 30 minutes) and upon study treatment discontinuation. Note that the ECG is to be completed prior to the PK blood draw.
12-lead ECG
xannot-017 17
T1:17
1
At selected sites, a subset of patients (approximately 24) will undergo triplicate ECG testing on Day 1 only at baseline (predose) and 1, 1.5, 2, 3, 4, 6 and 8 hours postdose. Triplicate ECGs should be performed between 2-5 minutes apart and should be performed prior to blood draws for PK.
Triplicate ECGs (selected sites only)1 cells
xannot-018 18
T1:18
1
Formalin fixed, paraffin-embedded tumor sample (primary or metastatic site) consisting of 100 micron thickness of sections (≥ 80 micron minimum) or unsectioned paraffin block.
Tumor sample
xannot-019 19
T1:19
1
Blood samples for PK collected on Cycle 1/Day 1 and Cycle 2/Day 1 collected predose (within 30 minutes) and 2 hours postdose (within 30± 15 minutes Note: The exact time of the PK blood draw will be recorded and ECG monitoring is to be completed prior to the PK blood draw.
Blood sample for PK1 cells
xannot-020 20
T1:20
1
At selected sites, a subset of patients (approximately 12) undergoing intensive PK on Day1 will have samples collected at baseline (within 30 minutes predose) and 1, 1.5, 2, 3, 4, 6 and 8 hours (± 2 minutes at all time points) postdose. Note: The exact time of the PK blood draw will be recorded and the ECG monitoring is to be completed prior to the PK blood draw.
Blood sample for PK1 cells
xannot-021 21
T1:21
1
Additional blood samples for PK on Cycle 4/Day 1 and Cycle 8/Day 1 will be collected at predose (trough) within 30 minutes only.
Blood sample for PK1 cells
xannot-022 22
T1:22
1
RECIST tumor assessment via CT or MRI scan of abdomen/pelvis and clinically indicated areas required at baseline, then after every 2 cycles (ie, 8 weeks with a window of ± 7 days from date of visit) through Cycle 14 (56 weeks), then after every 6 cycles (24 weeks with a window of ± 7 days) until study treatment discontinuation; at this point, a final follow-up set of imaging is required. PET/CT may be used according to RECIST guidelines. Cycle timing will not be delayed for treatment interruptions, and tumor assessment should occur according to this schedule regardless of whether study treatment is interrupted. If a patient discontinues treatment for clinical progression and does not meet the criteria specified in the protocol, scans and CA-125 testing should continue at the specified intervals until progression is confirmed or until the start of subsequent anticancer treatment.
Tumor Assessment (RECIST)
xannot-023 23
T1:23
1
Chest CT/MRI if not done as part of RECIST tumor assessment at Screening. If the chest CT/MRI is clear at screening, repeat chest imaging is not required in the absence of lesions to be followed or in the absence of clinical indication requiring follow‐up.
Chest CT/MRI
xannot-024 24
T1:24
1
PROs (FOSI, EQ-5D-5L, neuropathy questionnaire) will be collected while on study treatment every 8 weeks through the first year, then every 12 weeks thereafter. If the patient discontinues study treatment, assessment will occur at that time and then 8 weeks (± 2 weeks) later, regardless of status of subsequent treatment. PROs should be administered before conducting any other procedures.
FOSI, EQ-5D-5L, neuropathy questionnaire
xannot-025 25
T1:25
1
No new capsules dispensed
Study treatment dispensed/collected1 cells
xannot-026 26
T1:26
1
Every 90 days following study treatment discontinuation.
Anti-cancer therapies assessment1 cells
xannot-027 27
T1:27
1
In addition to survival, this assessment includes outcomes for subsequent anticancer therapies including any new malignancy information.
Survival assessment
xannot-028 28
T1:28, T2:15
2
For any suspected MDS/AML case reported while a patient is receiving treatment or being followed for post-treatment assessments, bone marrow aspirate and biopsy testing must be completed by a local hematologist. Testing completed as part of standard of care is sufficient as long as the methods are acceptable to the Sponsor’s Medical Monitor. The study site must receive a copy of the hematologist's report of aspirate/biopsy findings (which must include a classification according to WHO criteria²⁰) and other sample testing results related to MDS/AML.
Bone marrow aspirate and biopsy15 cells
xannot-029 29
T2:3
1
Negative serum pregnancy test required within 72 hours prior to study treatment for females of childbearing potential; repeated every 3 months for duration of study (ie, Cycle 4, Cycle 7, etc).
Pregnancy test2 cells
xannot-030 30
T2:4
1
Patients will be randomized in a crossover design within 72 hours prior to FE Day 1 (first single dose).
Randomization1 cells
xannot-031 31
T2:5
1
Patients receive a single oral dose of niraparib 300 mg on FE Days 1 and 8.
Study treatment dispensed/collected2 cells
xannot-032 32
T2:6
1
No new capsules dispensed.
Study treatment dispensed/collected1 cells
xannot-033 33
T2:8
1
Urinalysis parameters must include: specific gravity, leukocyte esterase, nitrite, blood, protein, glucose, ketones, urobilinogen and bilirubin.
Urinalysis
xannot-034 34
T2:9
1
12-lead ECG at Screening, Cycle 1/Day 1 (predose and 2 hours postdose), Cycle 2/Day 1 (predose and 2 hours postdose), and at treatment discontinuation. ECG monitoring is to be performed prior to PK blood draws.
12-lead ECG
xannot-035 35
T2:10
1
Triplicate ECG monitoring to coincide with PK on FE Days 1 and 8 at baseline (predose) and at 1, 1.5, 2, 3, 4, 6, and 8 hours post-dose. Triplicate ECGs should be performed between 2-5 minutes apart and should be performed prior to blood draws for PK.
12-lead ECG2 cells
xannot-036 36
T2:11
1
Blood samples for PK will be taken on FE Days 1 and 8 at baseline (within 30 minutes prior to dosing) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose. Additional blood samples will be collected predose and 2 hours postdose on Day 1 of Cycles 1 and 2 and predose only on Day 1 of Cycles 4 and 8. The exact time of the PK blood draw will be recorded and PK blood draws are to be completed after ECG monitoring.
Blood sample for PK
xannot-037 37
T2:n1
1
Note: Patients in food effect sub-study will receive a single oral dose of niraparib 300 mg on FE Days 1 and 8. Upon completion of the 14-day sub-study, patients will then start open-label treatment with daily niraparib (300 mg QD) on Day 1/Cycle 1 (approximately 2 weeks after start of food effect sub-study) and will be followed using the main study visit schedule for safety.
table
xannot-038 38
T3:1
1
During the in-clinic visit extended cycle, all study procedures and assessments required will be performed.
Subsequent Cycles
xannot-039 39
T3:2
1
The study coordinator will contact the patient by telephone to obtain information for the ECOG performance status, adverse event monitoring, and concomitant medications when the study assessments are not performed in clinic.
Subsequent Cycles
xannot-040 40
T3:3
1
The collection of blood samples for CBC and chemistry analysis, vital signs and weight may be collected during visit to local clinic or at in-home nursing visit when the study assessments are not performed in clinic.
Subsequent Cycles
xannot-041 41
T3:4
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3); no confident Table 7 (Main Study) equivalent for this Vital signs cell in the 'Patient Visit to Local Clinic or In-Home Nursing' column. Clinical review 2026-08-15: remains unresolved — no Table 7 candidate (Table 7's vital-signs footnote is "Height obtained at screening only"); §7.4.1 confirms vital signs at the local clinic/in-home nursing visit, content already covered by printed footnote 3.
Vital signs, height, weight1 cells
xannot-042 42
T3:5
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 10: "SAEs recorded up to 30 days after study treatment discontinuation." Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists "AEs (SAEs recorded 30 days post study treatment discontinuation)".
Adverse event monitoring1 cells
xannot-043 43
T3:6
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 12: "If dose interruption or modification is required at any point on study because of hematologic toxicity, weekly blood draws for CBC will be monitored until the adverse event resolves, and to ensure safety of the new dose, weekly blood draws for CBC will be also be required for an additional 4 weeks after the adverse event has been resolved to the specified levels, after which monitoring every 4 weeks may resume." Clinical review 2026-08-15: hypothesis retained; §7.4 does not restate this rule.
CBC
xannot-044 44
T3:7
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 13: "CA-125 levels must be normal at screening or > 90% decrease as compared with baseline prior to last platinum-based chemotherapy course. Abnormal CA-125 levels during study do not represent disease progression; however, they may prompt imaging if clinically indicated. CA-125 sample within 72 hours of dose on Cycle 1/Day 1." Clinical review 2026-08-15: hypothesis retained; note the screening and Cycle 1/Day 1 clauses of footnote 13 are phase-specific and may not apply in extended cycles; §7.4 is silent on CA-125 rules.
Serum CA-125
xannot-045 45
T3:8
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 14: "For determination of CA-125 progression, at least 2 CA-125 values at least 1 week apart are required for confirmation (Section 6.1)." Clinical review 2026-08-15: hypothesis retained; content is phase-independent; §7.4 does not restate it.
Serum CA-125
xannot-046 46
T3:9
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 16: "Patients will have a 12-lead ECG at Screening, Baseline (predose, within 30 minutes), 2 hours postdose on Day 1(within 30 minutes), Cycle 2/Day 1, (predose, 2 hours postdose, within 30 minutes) and upon study treatment discontinuation. Note that the ECG is to be completed prior to the PK blood draw." Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists 12-lead ECG at study treatment discontinuation — the only ECG mark in this table; the screening/PK clauses of footnote 16 do not apply in extended cycles.
12-lead ECG
xannot-047 47
T3:10
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 22: "RECIST tumor assessment via CT or MRI scan of abdomen/pelvis and clinically indicated areas required at baseline, then after every 2 cycles (ie, 8 weeks with a window of ± 7 days from date of visit) through Cycle 14 (56 weeks), then after every 6 cycles (24 weeks with a window of ± 7 days) until study treatment discontinuation; at this point, a final follow-up set of imaging is required. PET/CT may be used according to RECIST guidelines. Cycle timing will not be delayed for treatment interruptions, and tumor assessment should occur according to this schedule regardless of whether study treatment is interrupted. If a patient discontinues treatment for clinical progression and does not meet the criteria specified in the protocol, scans and CA-125 testing should continue at the specified intervals until progression is confirmed or until the start of subsequent anticancer treatment." NOTE (clinical review 2026-08-15): §7.4.2 states RECIST "after every 2 cycles through Cycle 14 and then after every 3 cycles", which conflicts with footnote 22's post-Cycle-14 cadence of every 6 cycles (24 weeks) — a source-internal contradiction, left unresolved; hypothesis retained.
Tumor Assessment (RECIST)
xannot-048 48
T3:11
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 24: "PROs (FOSI, EQ-5D-5L, neuropathy questionnaire) will be collected while on study treatment every 8 weeks through the first year, then every 12 weeks thereafter. If the patient discontinues study treatment, assessment will occur at that time and then 8 weeks (± 2 weeks) later, regardless of status of subsequent treatment. PROs should be administered before conducting any other procedures." Mapping confirmed by clinical review (2026-08-15): §7.4.2 states PROs every 3 cycles (= every 12 weeks, matching footnote 24) and repeats "PROs should be administered before conducting any other procedures" verbatim; §7.4.4 matches the 8 (± 2) weeks post-discontinuation assessment.
FOSI, EQ-5D-5L, neuropathy questionnaire
xannot-049 49
T3:12
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 25: "No new capsules dispensed" Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists "Study treatment capsules collected" (no dispensing) at discontinuation.
Study treatment dispensed/collected1 cells
xannot-050 50
T3:13
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 26: "Every 90 days following study treatment discontinuation." Mapping confirmed by clinical review (2026-08-15): §7.4.4: "Assessment of next subsequent anticancer therapies will be assessed every 90 days (± 28 days) following study treatment discontinuation visit."
Anticancer therapies assessment1 cells
xannot-051 51
T3:14
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 27: "In addition to survival, this assessment includes outcomes for subsequent anticancer therapies including any new malignancy information." Mapping confirmed by clinical review (2026-08-15): §7.4.4: survival status every 90 days (± 28 days) post-discontinuation; "New malignancy information will also be collected as part of this assessment."
Survival assessment
xannot-052 52
T3:15
1
Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 28: "For any suspected MDS/AML case reported while a patient is receiving treatment or being followed for post-treatment assessments, bone marrow aspirate and biopsy testing must be completed by a local hematologist. Testing completed as part of standard of care is sufficient as long as the methods are acceptable to the Sponsor’s Medical Monitor. The study site must receive a copy of the hematologist's report of aspirate/biopsy findings (which must include a classification according to WHO criteria) and other sample testing results related to MDS/AML." Mapping confirmed by clinical review (2026-08-15): §7.4.5 (Unscheduled Assessments) reproduces this text verbatim.