{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.90","pValueComment":"P-value is for NOD, Triplicate Combination Therapy Cycle 2. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.31","pValueComment":"P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.49","pValueComment":"P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.95","pValueComment":"P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.89","pValueComment":"P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.36","pValueComment":"P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.18","pValueComment":"P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.47","pValueComment":"P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.17","pValueComment":"P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.45","pValueComment":"P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.29","pValueComment":"P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.17","pValueComment":"P-value is for EIP, Maintenance Cycle 3. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.70","pValueComment":"P-value is for EIP, Maintenance Cycle 5. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.21","pValueComment":"P-value is for EIP, Maintenance Cycle 7. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.85","pValueComment":"P-value is for UOS, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.13","pValueComment":"P-value is for UOS, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.03","pValueComment":"P-value is for UOS, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.71","pValueComment":"P-value is for UOS, Maintenance Cycle 1. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.34","pValueComment":"P-value is for UOS, Maintenance Cycle 3. Threshold for statistical significance was 0.05","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.41","pValueComment":"P-value is for UOS, Maintenance Cycle 5. Threshold for statistical significance was 0.05","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.37","pValueComment":"P-value is for UOS, Maintenance Cycle 7. Threshold for statistical significance was 0.05","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.8","value":"-0.4"}]}],"title":"NOD-Change at Triplet Cycle 2 (n=53)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.2","value":"3.9"}]}],"title":"NOD-Change at Triplet Cycle 4 (n=41)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.5","value":"3.3"}]}],"title":"NOD-Change at Triplet Cycle 6 (n=24)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.9","value":"0.4"}]}],"title":"NOD-Change at Maintenance Cycle 1 (n=23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.3","value":"-1.0"}]}],"title":"NOD-Change at Maintenance Cycle 3 (n=10)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.4","value":"8.3"}]}],"title":"NOD-Change at Maintenance Cycle 5 (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.0","value":"-8.0"}]}],"title":"NOD-Change at Maintenance Cycle 7 (n=5)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.4","value":"2.7"}]}],"title":"EIP-Change at Triplet Cycle 2 (n=46)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.3","value":"-6.8"}]}],"title":"EIP-Change at Triplet Cycle 4 (n=37)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.8","value":"-3.4"}]}],"title":"EIP-Change at Triplet Cycle 6 (n=22)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"38.1","value":"-8.7"}]}],"title":"EIP-Change at Maintenance Cycle 1 (n=23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.1","value":"-10.0"}]}],"title":"EIP-Change at Maintenance Cycle 3 (n=10)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.6","value":"-4.2"}]}],"title":"EIP-Change at Maintenance Cycle 5 (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.4","value":"-15.0"}]}],"title":"EIP-Change at Maintenance Cycle 7 (n=5)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.0","value":"0.5"}]}],"title":"UOS-Change at Triplet Cycle 2 (n=53)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.6","value":"-4.3"}]}],"title":"UOS-Change at Triplet Cycle 4 (n=41)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.0","value":"-10.4"}]}],"title":"UOS-Change at Triplet Cycle 6 (n=24)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.1","value":"-1.1"}]}],"title":"UOS-Change at Maintenance Cycle 1 (n=23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.9","value":"-2.5"}]}],"title":"UOS-Change at Maintenance Cycle 3 (n=10)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"34.5","value":"-12.5"}]}],"title":"UOS-Change at Maintenance Cycle 5 (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"33.5","value":"-15.0"}]}],"title":"UOS-Change at Maintenance Cycle 7 (n=5)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"}],"units":"Participants"}],"description":"PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant's speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.","dispersionType":"Standard Deviation","groups":[{"description":"Pemetrexed 500 mg/m\\^2 administered by IV infusion followed by cisplatin 75 mg/m\\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.","id":"OG000","title":"Pemetrexed Cisplatin Cetuximab"}],"paramType":"MEAN","populationDescription":"PQ Population: all randomized and treated participants with evaluable data at respective timepoint.","reportingStatus":"POSTED","timeFrame":"Baseline, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)","title":"Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)","type":"SECONDARY","unitOfMeasure":"units on a scale"}