{"analyses":[{"groupDescription":"Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \\> 90% with a 1-sided binomial test at the 0.10 level.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3","statisticalComment":"One-sided significance level = 0.10","statisticalMethod":"binomial test"},{"groupDescription":"Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \\> 90% with a 1-sided binomial test at the 0.10 level.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.07","statisticalComment":"One-sided significance level = 0.10","statisticalMethod":"binomial test"}],"classes":[{"categories":[{"measurements":[{"comment":"One-sided interval","groupId":"OG000","lowerLimit":"87.7","value":"92.0"}]}],"title":"Progression-free Survival"},{"categories":[{"measurements":[{"comment":"One-side interval","groupId":"OG000","lowerLimit":"90.6","value":"94.5"}]}],"title":"Local-regional failure"}],"denoms":[{"counts":[{"groupId":"OG000","value":"115"}],"units":"Participants"}],"description":"NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \\> 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis.","dispersionType":"90% Confidence Interval","groups":[{"description":"IMRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy.\n\nIMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy","id":"OG000","title":"Both Arms Combined"}],"paramType":"NUMBER","populationDescription":"Randomized and eligible participants with negative post-treatment PET","reportingStatus":"POSTED","timeFrame":"3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)","title":"Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years","type":"SECONDARY","unitOfMeasure":"percentage of participants"}