{"analyses":[{"groupDescription":"H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.\n\nHa: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.218","statisticalComment":"Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.","statisticalMethod":"Fisher Exact","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.6","upperLimit":"23.2","value":"12.5"},{"groupId":"OG001","lowerLimit":"2.2","upperLimit":"15.1","value":"6.8"},{"groupId":"OG002","lowerLimit":"7.9","upperLimit":"27.3","value":"15.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"63"}],"units":"Participants"}],"description":"This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.","dispersionType":"95% Confidence Interval","groups":[{"description":"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.\n\nofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.","id":"OG000","title":"Ciprofloxacin or Ofloxacin"},{"description":"trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \\[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\\] every 12 hours for two months..","id":"OG001","title":"TMP-SMX"},{"description":"The patient will receive no prophylactic antibiotics.","id":"OG002","title":"No Prophylaxis"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"First three months of chemotherapy","title":"Proportion of Patients Experiencing a Serious Bacterial Infection","type":"PRIMARY","unitOfMeasure":"percentage of participants"}