The count and percentage of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]).\nEvaluated per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) as assessed b MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Beta will be used as priors for combination regimens in calculating the posterior distribution of the pathologic complete response [pCR] for each respective treatment group.\nAmong subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.
"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description","value":"The count and percentage of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]).\nEvaluated per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) as assessed b MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Beta will be used as priors for combination regimens in calculating the posterior distribution of the pathologic complete response [pCR] for each respective treatment group.\nAmong subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.
"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reportingStatus","value":"POSTED"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/anticipatedPostingDate"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType","value":"COUNT_OF_PARTICIPANTS"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure","value":"Participants"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups","value":[{"description":"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
","id":"OG000","title":"Arm 1 (Paclitaxel, Carboplatin)"},{"description":"Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
Veliparib: Given PO
","id":"OG001","title":"Arm 2 (Veliparib, Paclitaxel, Carboplatin)"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms","value":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes","value":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}],"title":"Progressive Disease"},{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"title":"Partial Response"},{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}],"title":"Pathological Complete Response"}]}]},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus","value":"POSTED"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/anticipatedPostingDate"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription","value":"Sincere efforts have been made to gather and report the data, however, no data is available for this outcome measure."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups","value":[{"description":"Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
","id":"OG000","title":"Arm 1 (Paclitaxel, Carboplatin)"},{"description":"Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
Veliparib: Given PO
","id":"OG001","title":"Arm 2 (Veliparib, Paclitaxel, Carboplatin)"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]}],"provenance":{"from_snapshot_hash":"2703396162a61900538160a3df5b8276027ec631719c575fee4a98ee60174aa1","materiality_event_hash":"1fdd20ef7050961d6def5d6fe2aeabcda0d4ce930c092eb68c9ec39c1f8b71c0","patch_hash":"9f33259e10bab354ac0de6619ac9cae402b3851181d0c3f98bb4c3914c0cf58e","patch_raw_hash":"c925a77d17281c3eab268b28441974da9aa18ed49e047d486d8247ac159b2ae9","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT01818063/history/17?patchToVersion=18","to_snapshot_hash":"7900f3068dfdcd7d26b4ba0bc45f9095365fc43e164a6f3af05e0bb6dc6e9340"},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT01818063","nct_id":"NCT01818063"},"versions":{"from_version":17,"submitted_date":"2019-10-07","to_version":18}}