{"description":"SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.","eventGroups":[{"description":"Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"EG000","otherNumAffected":215,"otherNumAtRisk":218,"seriousNumAffected":16,"seriousNumAtRisk":218,"title":"Dexamethasone and Capizzi Methotrexate Patients < 10 Years"},{"description":"Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"EG001","otherNumAffected":87,"otherNumAtRisk":90,"seriousNumAffected":17,"seriousNumAtRisk":90,"title":"Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)"},{"description":"Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"EG002","otherNumAffected":250,"otherNumAtRisk":261,"seriousNumAffected":42,"seriousNumAtRisk":261,"title":"Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old"},{"description":"Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"EG003","otherNumAffected":203,"otherNumAtRisk":206,"seriousNumAffected":25,"seriousNumAtRisk":206,"title":"Dexamethasone, High Dose Methotrexate (IM) < 10 Years"},{"description":"Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"EG004","otherNumAffected":212,"otherNumAtRisk":214,"seriousNumAffected":20,"seriousNumAtRisk":214,"title":"Prednisone, Capizzi Methotrexate <10 Years"},{"description":"Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"EG005","otherNumAffected":564,"otherNumAtRisk":598,"seriousNumAffected":64,"seriousNumAtRisk":598,"title":"Prednisone, Capezzi Methotrexate >= 10 Years"},{"description":"Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"EG006","otherNumAffected":204,"otherNumAtRisk":213,"seriousNumAffected":16,"seriousNumAtRisk":213,"title":"Prednisone and High Dose Methotrexate < 10 Yrs Old"},{"description":"Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"EG007","otherNumAffected":576,"otherNumAtRisk":601,"seriousNumAffected":67,"seriousNumAtRisk":601,"title":"Prednisone and High Dose Methotrexate >=10 Years"},{"description":"Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"EG008","otherNumAffected":256,"otherNumAtRisk":262,"seriousNumAffected":27,"seriousNumAtRisk":262,"title":"Dexamethasone, High Dose Methotrexate (IM) >= 10 Years"},{"description":"Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"EG009","otherNumAffected":30,"otherNumAtRisk":30,"seriousNumAffected":3,"seriousNumAtRisk":30,"title":"Prednisone, Capezzi Methotrexate (Down's Syndrome)"},{"description":"Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"EG010","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":3,"seriousNumAtRisk":9,"title":"Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)"},{"description":"Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"EG011","otherNumAffected":20,"otherNumAtRisk":23,"seriousNumAffected":1,"seriousNumAtRisk":23,"title":"Prednisone and High Dose Methotrexate (Non Randomly Assigned)"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":218,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":90,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":261,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":206,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":214,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":598,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":213,"numEvents":3},{"groupId":"EG007","numAffected":1,"numAtRisk":601,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":262,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Abdominal distension"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":218,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":261,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":206,"numEvents":1},{"groupId":"EG004","numAffected":4,"numAtRisk":214,"numEvents":4},{"groupId":"EG005","numAffected":6,"numAtRisk":598,"numEvents":6},{"groupId":"EG006","numAffected":2,"numAtRisk":213,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":601,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":262,"numEvents":1},{"groupId":"EG009","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Abdominal infection"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":218,"numEvents":13},{"groupId":"EG001","numAffected":12,"numAtRisk":90,"numEvents":15},{"groupId":"EG002","numAffected":38,"numAtRisk":261,"numEvents":45},{"groupId":"EG003","numAffected":16,"numAtRisk":206,"numEvents":20},{"groupId":"EG004","numAffected":12,"numAtRisk":214,"numEvents":13},{"groupId":"EG005","numAffected":52,"numAtRisk":598,"numEvents":68},{"groupId":"EG006","numAffected":9,"numAtRisk":213,"numEvents":9},{"groupId":"EG007","numAffected":35,"numAtRisk":601,"numEvents":46},{"groupId":"EG008","numAffected":16,"numAtRisk":262,"numEvents":23},{"groupId":"EG009","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG010","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Abdominal pain"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":218,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":261,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":206,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":214,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":598,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":213,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":601,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":262,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Accessory nerve disorder"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":218,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":90,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":261,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":206,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":214,"numEvents":3},{"groupId":"EG005","numAffected":10,"numAtRisk":598,"numEvents":10},{"groupId":"EG006","numAffected":0,"numAtRisk":213,"numEvents":0},{"groupId":"EG007","numAffected":14,"numAtRisk":601,"numEvents":14},{"groupId":"EG008","numAffected":6,"numAtRisk":262,"numEvents":7},{"groupId":"EG009","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Acidosis"},{"organSystem":"Investigations","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":218,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":90,"numEvents":6},{"groupId":"EG002","numAffected":11,"numAtRisk":261,"numEvents":18},{"groupId":"EG003","numAffected":6,"numAtRisk":206,"numEvents":8},{"groupId":"EG004","numAffected":4,"numAtRisk":214,"numEvents":5},{"groupId":"EG005","numAffected":18,"numAtRisk":598,"numEvents":19},{"groupId":"EG006","numAffected":6,"numAtRisk":213,"numEvents":6},{"groupId":"EG007","numAffected":18,"numAtRisk":601,"numEvents":22},{"groupId":"EG008","numAffected":10,"numAtRisk":262,"numEvents":13},{"groupId":"EG009","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG010","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Activated partial thromboplastin time prolonged"},{"organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":218,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":90,"numEvents":2},{"groupId":"EG002","numAffected":12,"numAtRisk":261,"numEvents":13},{"groupId":"EG003","numAffected":1,"numAtRisk":206,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":214,"numEvents":2},{"groupId":"EG005","numAffected":16,"numAtRisk":598,"numEvents":17},{"groupId":"EG006","numAffected":1,"numAtRisk":213,"numEvents":1},{"groupId":"EG007","numAffected":13,"numAtRisk":601,"numEvents":13},{"groupId":"EG008","numAffected":12,"numAtRisk":262,"numEvents":15},{"groupId":"EG009","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG010","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Acute kidney injury"},{"organSystem":"Endocrine disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":218,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":261,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":206,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":214,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":598,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":213,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":601,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":262,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Adrenal insufficiency"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":218,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":261,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":206,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":214,"numEvents":0},{"groupId":"EG005","numAffected":6,"numAtRisk":598,"numEvents":6},{"groupId":"EG006","numAffected":0,"numAtRisk":213,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":601,"numEvents":5},{"groupId":"EG008","numAffected":7,"numAtRisk":262,"numEvents":8},{"groupId":"EG009","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Adult respiratory distress syndrome"},{"organSystem":"Psychiatric disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":218,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":90,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":261,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":206,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":214,"numEvents":2},{"groupId":"EG005","numAffected":6,"numAtRisk":598,"numEvents":8},{"groupId":"EG006","numAffected":3,"numAtRisk":213,"numEvents":3},{"groupId":"EG007","numAffected":4,"numAtRisk":601,"numEvents":5},{"groupId":"EG008","numAffected":0,"numAtRisk":262,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Agitation"},{"organSystem":"Investigations","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":96,"numAtRisk":218,"numEvents":272},{"groupId":"EG001","numAffected":33,"numAtRisk":90,"numEvents":88},{"groupId":"EG002","numAffected":122,"numAtRisk":261,"numEvents":305},{"groupId":"EG003","numAffected":94,"numAtRisk":206,"numEvents":294},{"groupId":"EG004","numAffected":92,"numAtRisk":214,"numEvents":263},{"groupId":"EG005","numAffected":274,"numAtRisk":598,"numEvents":780},{"groupId":"EG006","numAffected":101,"numAtRisk":213,"numEvents":352},{"groupId":"EG007","numAffected":275,"numAtRisk":601,"numEvents":749},{"groupId":"EG008","numAffected":125,"numAtRisk":262,"numEvents":303},{"groupId":"EG009","numAffected":12,"numAtRisk":30,"numEvents":27},{"groupId":"EG010","numAffected":2,"numAtRisk":9,"numEvents":3},{"groupId":"EG011","numAffected":10,"numAtRisk":23,"numEvents":18}],"term":"Alanine aminotransferase increased"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":218,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":261,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":206,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":214,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":598,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":213,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":601,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":262,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Alcohol intolerance"},{"organSystem":"Investigations","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":218,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":90,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":261,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":206,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":214,"numEvents":4},{"groupId":"EG005","numAffected":4,"numAtRisk":598,"numEvents":5},{"groupId":"EG006","numAffected":3,"numAtRisk":213,"numEvents":4},{"groupId":"EG007","numAffected":1,"numAtRisk":601,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":262,"numEvents":2},{"groupId":"EG009","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG011","numAffected":2,"numAtRisk":23,"numEvents":2}],"term":"Alkaline phosphatase increased"},{"organSystem":"Metabolism and nutrition 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