{"analyses":[{"ciLowerLimit":"0.050","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.498","groupDescription":"The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.05","paramType":"Risk Ratio (RR)","paramValue":"0.158","statisticalMethod":"Chi-squared","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"description":"The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.","groups":[{"description":"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.\n\nPlacebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.","id":"OG000","title":"Placebo"},{"description":"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.\n\nLow Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.","id":"OG001","title":"Low Level Laser Therapy"}],"paramType":"NUMBER","populationDescription":"Data related to the primary endpoint were handled in a per protocol treatment analysis.","reportingStatus":"POSTED","timeFrame":"7 weeks","title":"Incidence and / or Severity of Oral Mucositis","type":"PRIMARY","unitOfMeasure":"Grade 3-4 oral mucositis"}