{"description":"By protocol definitions, only grade 1-3 adverse events that were deemed definitely, possibly, or probably related to treatment and all grade 3-5 severe adverse events (SAEs) were to be reported.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":86,"description":"All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.\n\nStandard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":86,"seriousNumAffected":0,"seriousNumAtRisk":86,"title":"Standard Oral Hygiene"},{"deathsNumAffected":0,"deathsNumAtRisk":86,"description":"All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.\n\nThe True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes.\n\nStandard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care.\n\n14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":86,"seriousNumAffected":0,"seriousNumAtRisk":86,"title":"Standard Oral Hygiene + True Acupuncture"},{"deathsNumAffected":1,"deathsNumAtRisk":86,"description":"All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.\n\nThe Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points.\n\nStandard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care.\n\n14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.","id":"EG002","otherNumAffected":3,"otherNumAtRisk":86,"seriousNumAffected":0,"seriousNumAtRisk":86,"title":"Standard Oral Hygiene + Sham Acupuncture"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":86,"numEvents":1}],"term":"Edema face"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":86,"numEvents":1}],"term":"Flu like systoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v.50","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":86,"numEvents":1}],"term":"Joint Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":86,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":86,"numEvents":0}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":86,"numEvents":0}],"term":"Bruising"}],"timeFrame":"Collected at weeks 4, 8, 12 and 24. July 29,2013 under the oversight of the MD Anderson Community Clinical Oncology Program Research Base (MDA CCOP RB) (NCI DCP #MDA 04-01; MD Anderson Protocol #2010-0547). (WF-97115) from April 2016 through June 2021."}