{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"28"},{"groupId":"OG004","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"28"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"description":"Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","groups":[{"description":"Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 70 mg/m\\^2 for initial tolerability study (closed) Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles 6 participants to bendamustine 70 mg/m\\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.","id":"OG000","title":"Non-Randomized to 70 mg/m2 Bendamustine-Rituximab"},{"description":"Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\\^2 for initial tolerability study (closed) Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 6 participants to bendamustine 90 mg/m\\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated","id":"OG001","title":"Non-randomized to 90 mg/m^2 Bendamustine-Rituximab"},{"description":"Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\\^2 Rituximab: 28 participants Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine:28 participants to bendamustine 90 mg/m\\^2/day, days 1 and 2 each cycle, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.","id":"OG002","title":"Randomized to 90 mg/m^2 Bendamustine-Rituximab"},{"description":"Treatment Assignment Code 2 (TAC 2) Rituximab + Pentostatin\n\nPentostatin: 28 participants to pentostatin 4 mg/m\\^2 days 1 and 15 of each cycle.\n\nRituximab: Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles\n\nAcetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated.\n\nIntravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.","id":"OG003","title":"Randomized to Pentostatin-Rituximab"},{"description":"Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\\^2 or Rituxan + Pentostatin After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 1-4 participants to bendamustine 90 mg/m\\^2/day, days 1 and 2 each cycle Pentostatin 1-4 participants to pentostatin 4 mg/m\\^2 days 1 and 15 of each cycle.\n\nAcetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.","id":"OG004","title":"Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 103 months and 19 days; 133 months and 11 days; 111 months and 15 days; 102 months and 25 days; 44 months and 14 days; and 19 months and 2 days for each group respectively.","title":"Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}