{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"417"},{"groupId":"OG001","value":"395"}]}],"title":"At least 1 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"371"}]}],"title":"≥ 1 Treatment related AE (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"172"}]}],"title":"At least 1 Serious Adverse Event (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"53"}]}],"title":"≥ 1 treatment related SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"370"},{"groupId":"OG001","value":"298"}]}],"title":"≥ 1 Grade (GR) 3/4 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"374"},{"groupId":"OG001","value":"303"}]}],"title":"≥ 1 Grade 3 or higher AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"95"}]}],"title":"≥ 1 AE leading to stopping treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"18"}]}],"title":"≥ 1 AE leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"125"}]}],"title":"≥ 1 AE leading to dose reduction of ABI-007 or Gem"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"title":"≥ 1 AE related dose interruption of ABI-007 or Gem"},{"categories":[{"measurements":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"192"}]}],"title":"≥ 1 AE related dose delay of ABI-007 or Gem"}],"denoms":[{"counts":[{"groupId":"OG000","value":"421"},{"groupId":"OG001","value":"402"}],"units":"Participants"}],"description":"A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.","groups":[{"description":"Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest","id":"OG000","title":"Albumin-bound Paclitaxel (ABI-007)/Gemcitabine"},{"description":"Gemcitabine 1000 mg/m\\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)","id":"OG001","title":"Gemcitabine"}],"paramType":"NUMBER","populationDescription":"Treated patient population","reportingStatus":"POSTED","timeFrame":"Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days","title":"Participants With Treatment Emergent Adverse Events (AE)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"participants"}