{"protocolSection":{"identificationModule":{"nctId":"NCT01302964","orgStudyIdInfo":{"id":"2012P001009"},"organization":{"fullName":"Massachusetts General Hospital","class":"OTHER"},"briefTitle":"Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders","officialTitle":"Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders"},"statusModule":{"statusVerifiedDate":"2018-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-08"},"primaryCompletionDateStruct":{"date":"2017-10-10","type":"ACTUAL"},"completionDateStruct":{"date":"2017-10-10","type":"ACTUAL"},"studyFirstSubmitDate":"2010-08-25","studyFirstSubmitQcDate":"2011-02-18","studyFirstPostDateStruct":{"date":"2011-02-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-10-10","resultsFirstSubmitQcDate":"2018-10-10","resultsFirstPostDateStruct":{"date":"2018-11-07","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-10-10","lastUpdatePostDateStruct":{"date":"2018-11-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Christopher John McDougle, M.D.","investigatorTitle":"Director, Lurie Center for Autism","investigatorAffiliation":"Massachusetts General Hospital"},"leadSponsor":{"name":"Massachusetts General Hospital","class":"OTHER"},"collaborators":[{"name":"Autism Speaks","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.","detailedDescription":"One of the areas receiving very little attention in Pervasive Developmental Disorders (PDDs) is that of anxiety. Anxiety is common in PDD, but has not yet been fully characterized. The primary objective of this study is to conduct a preliminary placebo-controlled trial of mirtazapine for the treatment of anxiety associated with PDDs. We hypothesize that mirtazapine will be safe and well tolerated."},"conditionsModule":{"conditions":["Autism Spectrum Disorders"],"keywords":["Autistic Disorder","Asperger's Disorder","Pervasive Developmental Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Mirtazapine","type":"EXPERIMENTAL","description":"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.","interventionNames":["Drug: Mirtazapine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Subjects randomized to placebo will receive placebo for duration of the study","armGroupLabels":["Placebo"],"otherNames":["Sugar pill"]},{"type":"DRUG","name":"Mirtazapine","description":"Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg per week for subjects weighing less than 50 kg and up to 15 mg per week for subjects weighing more than 50 kg depending on efficacy and tolerability.","armGroupLabels":["Mirtazapine"],"otherNames":["Remeron"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase","description":"The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories), and their interaction as covariates, and assuming a common mean between treatment groups at baseline. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.","timeFrame":"Weeks Baseline, 2, 4, 6, and 10"},{"measure":"Proportion of Participants Who Responded to Treatment at 10 Weeks According to the Improvement Item of the Clinical Global Impression-Scale (Response Defined as CGI-I=1 or CGI-I=2)","description":"The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). In this study the CGI was focused on the target symptom of anxiety. Participants with a CGI-I score of 1 or 2 were classified as responders. The CGI-I was administered biweekly for 6 weeks and again at 10 weeks during the study. The participant who withdrew from the study before 10 weeks was not included in the calculations.","timeFrame":"Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Ages 5-17 years\n* Diagnosis of autistic disorder, Asperger's disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS)\n* Clinically significant anxiety as evidenced by a Pediatric Anxiety Rating Scale (PARS) score of 10 or greater\n* Abbreviated intelligence quotient (IQ) greater than 50 on the Stanford Binet 5th Ed.\n\nExclusion Criteria:\n\n* Diagnosis of Rett's disorder or childhood integrative disorder\n* Diagnosis of obsessive-compulsive disorder (OCD), post-traumatic stress disorder, major mood disorder, psychotic disorder, or substance use disorder\n* Presence of any past or present medical conditions that would make treatment with mirtazapine unsafe\n* Use of other antidepressants or benzodiazepines\n* Use of other psychotropic medications which are ineffective, poorly tolerated, or sub-optimal in terms of dose\n* Previous adequate trial of mirtazapine","healthyVolunteers":false,"sex":"ALL","minimumAge":"5 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Christopher J. McDougle, M.D.","affiliation":"Indiana University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Riley Child and Adolescent Psychiatry Clinic Riley Hospital","city":"Indianapolis","state":"Indiana","zip":"46202","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Lurie Center -MassGeneral Hospital","city":"Lexington","state":"Massachusetts","zip":"02421","country":"United States","geoPoint":{"lat":42.44732,"lon":-71.2245}}]},"referencesModule":{"references":[{"pmid":"35241779","type":"DERIVED","citation":"McDougle CJ, Thom RP, Ravichandran CT, Palumbo ML, Politte LC, Mullett JE, Keary CJ, Erickson CA, Stigler KA, Mathieu-Frasier L, Posey DJ. A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder. Neuropsychopharmacology. 2022 May;47(6):1263-1270. doi: 10.1038/s41386-022-01295-4. Epub 2022 Mar 3."}],"seeAlsoLinks":[{"label":"Lurie Center Research","url":"http://www.massgeneral.org/children/services/lurie-center/research.aspx"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Mirtazapine","description":"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.\n\nMirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subjects weighing less than 50 kg and up to 15 mg weekly for subjects weighing more than 50 kg depending upon efficacy and tolerability."},{"id":"FG001","title":"Placebo","description":"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.\n\nPlacebo: Subjects randomized to placebo will receive placebo for duration of the study"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Mirtazapine","description":"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.\n\nMirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subjects weighing less than 50 kg and up to 15 mg weekly for subjects weighing more than 50 kg depending upon efficacy and tolerability."},{"id":"BG001","title":"Placebo","description":"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.\n\nPlacebo: Subjects randomized to placebo will receive placebo for duration of the study"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"30"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10.9","spread":"3.6"},{"groupId":"BG001","value":"11.3","spread":"4.1"},{"groupId":"BG002","value":"11.0","spread":"3.7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"24"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"24"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"26"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"30"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase","description":"The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories), and their interaction as covariates, and assuming a common mean between treatment groups at baseline. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.","populationDescription":"All randomized study participants","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Weeks Baseline, 2, 4, 6, and 10","groups":[{"id":"OG000","title":"Mirtazapine","description":"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.\n\nMirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subject weighing less than 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability."},{"id":"OG001","title":"Placebo","description":"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.\n\nPlacebo: Subjects randomized to placebo will receive placebo for duration of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.9","lowerLimit":"-7.3","upperLimit":"-2.6"},{"groupId":"OG001","value":"-3.2","lowerLimit":"-6.5","upperLimit":"0.2"}]}]}]},{"type":"PRIMARY","title":"Proportion of Participants Who Responded to Treatment at 10 Weeks According to the Improvement Item of the Clinical Global Impression-Scale (Response Defined as CGI-I=1 or CGI-I=2)","description":"The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). In this study the CGI was focused on the target symptom of anxiety. Participants with a CGI-I score of 1 or 2 were classified as responders. The CGI-I was administered biweekly for 6 weeks and again at 10 weeks during the study. The participant who withdrew from the study before 10 weeks was not included in the calculations.","populationDescription":"All randomized study participants with a 10 week CGI-I rating","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Proportion of participants","timeFrame":"Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)","groups":[{"id":"OG000","title":"Mirtazapine","description":"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.\n\nMirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subject weighing less than 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability."},{"id":"OG001","title":"Placebo","description":"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.\n\nPlacebo: Subjects randomized to placebo will receive placebo for duration of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.47"},{"groupId":"OG001","value":"0.20"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Ten weeks or at the time of latest data collection for the participant who did not complete the study.","description":"Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with mirtazapine at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.","eventGroups":[{"id":"EG000","title":"Mirtazapine","description":"The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.\n\nMirtazapine: Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subject weighing less than 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":20,"otherNumAtRisk":20},{"id":"EG001","title":"Placebo","description":"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.\n\nPlacebo: Subjects randomized to placebo will receive placebo for duration of the study","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":10,"otherNumAtRisk":10}],"otherEvents":[{"term":"Eye Irritation","organSystem":"Eye disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":10}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]},{"term":"Stomach or abdominal discomfort","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":10}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":10}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":10}]},{"term":"Taste abnormality","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Indigestion","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Sedation/Drowsiness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":20},{"groupId":"EG001","numAffected":6,"numAtRisk":10}]},{"term":"Appetite increase","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]},{"term":"Appetite decrease","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]},{"term":"Fever","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]},{"term":"Dry mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Tiredness/fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Accidental injury","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Other Pain","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Allergies Not Otherwise Specified","organSystem":"Immune system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Nasal congestion or Cold","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]},{"term":"Unspecified or not otherwise listed nose/throat","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Sinus condition","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Flu or upper respiratory problems","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]},{"term":"Ear Infection","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Sore throat","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Throat infection","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Unspecified or not otherwise listed mouth","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Unspecified or not otherwise listed, musculoskeletal","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]},{"term":"Sensory sensitivity","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Aggression","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Aggression (e.g. verbal threats to harm others, physical aggressions, not including disobedience or defiant/oppositional behavior)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":10}]},{"term":"Nightmares or Dreams","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]},{"term":"Irritability","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":10}]},{"term":"Sadness","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":10}]},{"term":"Difficulty falling asleep","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Interrupted sleep/other sleep problems","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Concentration difficulty","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Anxiety/Nervousness/Worry","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Body-focused repetitive behavior","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Change in speech","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Euphoria/Giddiness","organSystem":"Psychiatric 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