{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2399","statisticalComment":"Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet","statisticalMethod":"Pearson's Chi-squared test"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4584","statisticalComment":"Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands","statisticalMethod":"Pearson's Chi-squared test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"25"}]}],"title":"Feet, 0-Not at all"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"5"}]}],"title":"Feet, 1-A little bit"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"15"}]}],"title":"Feet, 2-Somewhat"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"10"}]}],"title":"Feet, 3-Quite a bit"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"3"}]}],"title":"Feet, 4-Very much"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"31"}]}],"title":"Hands, 0-Not at all"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"16"}]}],"title":"Hands, 1-A little bit"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"6"}]}],"title":"Hands, 2-Somewhat"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}]}],"title":"Hands, 3-Quite a bit"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}],"title":"Hands, 4-Very much"}],"denoms":[{"counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"description":"A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of \"not at all\" (0) to \"very much\" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 (\"not at all\") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 (\"a little bit\").","groups":[{"description":"Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.","id":"OG000","title":"gBRCA Niraparib"},{"description":"Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.","id":"OG001","title":"gBRCA Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.","reportingStatus":"POSTED","timeFrame":"At Cycle 2 (Each cycle was of 28 days)","title":"Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2","type":"SECONDARY","unitOfMeasure":"Participants"}