{"analyses":[{"ciLowerLimit":"0.33","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.08","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.038","pValueComment":"P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.","paramType":"Odds Ratio (OR)","paramValue":"0.60","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"24","upperLimit":"43","value":"33"},{"groupId":"OG001","lowerLimit":"34","upperLimit":"55","value":"45"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"92"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.","dispersionType":"95% Confidence Interval","groups":[{"description":"Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).","id":"OG000","title":"Alisertib"},{"description":"Pralatrexate 30 mg/m\\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).","id":"OG001","title":"Pralatrexate, or Romidepsin, or Gemcitabine"}],"paramType":"NUMBER","populationDescription":"Response-evaluable population, participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at Baseline, who received at least 1 dose of alisertib or comparator and had postbaseline response assessment of CR, PR, stable disease (SD) or progressive disease (PD) by the IRC.","reportingStatus":"POSTED","timeFrame":"Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years","title":"Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment","type":"PRIMARY","unitOfMeasure":"percentage of participants"}