STUDYID,DOMAIN,USUBJID,AESEQ,AEREFID,AESPID,AETERM,AELLT,AELLTCD,AEDECOD,AEPTCD,AEHLT,AEHLTCD,AEHLGT,AEHLGTCD,AEBODSYS,AEBDSYCD,AESOC,AESOCCD,AESER,AEACN,AEACNOTH,AEREL,AEOUT,AESCONG,AESDISAB,AESDTH,AESHOSP,AESLIFE,AESMIE,AETOX,AETOXGR,EPOCH,AESTDTC,AEENDTC,AESTDY,AEENDY,AEENRF
043-18101,AE,043-18101-74001-001,1,6,,ALT Increase,ALT increased,10001845,Alanine aminotransferase increased,10001551,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SAFETY FOLLOW-UP,2019-05-20,,13,,ONGOING
043-18101,AE,043-18101-74001-001,2,7,,AST Increase,AST increased,10003544,Aspartate aminotransferase increased,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,SAFETY FOLLOW-UP,2019-05-20,,13,,ONGOING
043-18101,AE,043-18101-74001-001,3,4,,Blood Bilirubin Increase,Blood bilirubin increased,10005364,Blood bilirubin increased,10005364,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-05-17,,10,,ONGOING
043-18101,AE,043-18101-74001-001,4,8,,Confusion,Confusion,10010300,Confusional state,10010305,Confusion and disorientation,10010301,Deliria (incl confusion),10012221,Psychiatric disorders,10037175,Psychiatric disorders,10037175,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-05-17,,10,,ONGOING
043-18101,AE,043-18101-74001-001,5,9,,Delirium,Delirium,10012218,Delirium,10012218,Deliria,10012219,Deliria (incl confusion),10012221,Psychiatric disorders,10037175,Psychiatric disorders,10037175,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-05-17,,10,,ONGOING
043-18101,AE,043-18101-74001-001,6,5,,Diarrhea,Diarrhea,10012727,Diarrhoea,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-05-18,,11,,ONGOING
043-18101,AE,043-18101-74001-001,7,3,,Worsening Fatigue,Fatigue aggravated,10048415,Fatigue,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,N,DRUG WITHDRAWN,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,SEVERE,3,TREATMENT,2019-05-12,,5,,ONGOING
043-18101,AE,043-18101-74001-001,8,1,CM 1,Gastroesophageal reflux disease,Gastroesophageal reflux disease,10066874,Gastrooesophageal reflux disease,10017885,Gastrointestinal atonic and hypomotility disorders NEC,10017933,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-05-09,,2,,ONGOING
043-18101,AE,043-18101-74001-001,9,2,,Vomiting,Vomiting,10047700,Vomiting,10047700,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-05-10,,3,,ONGOING
043-18101,AE,043-18101-74001-002,1,1,CM 7,Tumor pain,Tumor pain,10045158,Tumour pain,10045171,Oncologic complications and emergencies,10030315,Neoplasm related morbidities,10068775,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,N,NOT APPLICABLE,CONCOMITANT MEDICATIONS,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,LONG-TERM FOLLOW-UP,2019-06-24,,41,,ONGOING
043-18101,AE,043-18101-74001-003,1,11,,Worsening Abdominal pain,Abdominal pain aggravated,10048358,Abdominal pain,10000081,Gastrointestinal and abdominal pains (excl oral and throat),10017926,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,SAFETY FOLLOW-UP,2019-05-20,,6,,ONGOING
043-18101,AE,043-18101-74001-003,2,3,PR 2,Anemia,Anemia,10002272,Anaemia,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,Y,DRUG WITHDRAWN,CONCURRENT PROCEDURES,RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,SAFETY FOLLOW-UP,2019-05-20,2019-05-22,6,8,
043-18101,AE,043-18101-74001-003,3,13,,AST Increase,AST increased,10003544,Aspartate aminotransferase increased,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,SAFETY FOLLOW-UP,2019-05-20,,6,,ONGOING
043-18101,AE,043-18101-74001-003,4,12,,Blood Bilirubin Increase,Blood bilirubin increased,10005364,Blood bilirubin increased,10005364,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED WITH SEQUELAE,,,,,,,MILD,1,SCREENING,2019-05-13,2019-05-19,-2,5,
043-18101,AE,043-18101-74001-003,5,7,CM 15,Blood Bilirubin Increase,Blood bilirubin increased,10005364,Blood bilirubin increased,10005364,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,SAFETY FOLLOW-UP,2019-05-20,,6,,ONGOING
043-18101,AE,043-18101-74001-003,6,4,,Worsening Fatigue,Fatigue aggravated,10048415,Fatigue,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-05-16,,2,,ONGOING
043-18101,AE,043-18101-74001-003,7,9,,Hepatic Failure,Hepatic failure,10019663,Hepatic failure,10019663,Hepatic failure and associated disorders,10019664,Hepatic and hepatobiliary disorders,10019654,Hepatobiliary disorders,10019805,Hepatobiliary disorders,10019805,Y,NOT APPLICABLE,NONE,RELATED,FATAL,,,Y,,,,DEATH,5,SAFETY FOLLOW-UP,2019-05-20,2019-05-26,6,12,
043-18101,AE,043-18101-74001-003,8,5,"CM 1,2",Laryngeal Mucositis,Laryngeal mucositis,10065880,Laryngeal inflammation,10065735,Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms),10023819,Upper respiratory tract disorders (excl infections),10046304,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,SEVERE,3,TREATMENT,2019-05-16,2019-05-19,2,5,
043-18101,AE,043-18101-74001-003,9,8,,Laryngeal Mucositis,Laryngeal mucositis,10065880,Laryngeal inflammation,10065735,Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms),10023819,Upper respiratory tract disorders (excl infections),10046304,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Y,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,Y,,,SEVERE,3,SAFETY FOLLOW-UP,2019-05-20,,6,,ONGOING
043-18101,AE,043-18101-74001-003,10,10,CM 6,Nausea,Nausea,10028813,Nausea,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,SEVERE,3,TREATMENT,2019-05-16,,2,,ONGOING
043-18101,AE,043-18101-74001-003,11,1,"CM 3,4",Neutropenia,Neutropenia,10029354,Neutropenia,10029354,Neutropenias,10029355,White blood cell disorders,10047954,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,Y,DRUG WITHDRAWN,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,Y,,,LIFE-THREATENING,4,SAFETY FOLLOW-UP,2019-05-20,2019-05-25,6,11,
043-18101,AE,043-18101-74001-003,12,2,PR 1,Thrombocytopenia,Thrombocytopenia,10043554,Thrombocytopenia,10043554,Thrombocytopenias,10043555,Platelet disorders,10035534,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,Y,DRUG WITHDRAWN,CONCURRENT PROCEDURES,RELATED,NOT RECOVERED/NOT RESOLVED,,,,Y,,,LIFE-THREATENING,4,SAFETY FOLLOW-UP,2019-05-20,,6,,ONGOING
043-18101,AE,043-18101-74001-003,13,6,,White blood cell decrease,White blood cell decreased,10049182,White blood cell count decreased,10047942,White blood cell analyses,10047938,Haematology investigations (incl blood groups),10018851,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,LIFE-THREATENING,4,SAFETY FOLLOW-UP,2019-05-20,2019-05-25,6,11,
043-18101,AE,043-18101-74001-004,1,8,,ALT Increase,ALT increased,10001845,Alanine aminotransferase increased,10001551,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2019-10-04,2019-10-11,22,29,
043-18101,AE,043-18101-74001-004,2,12,,ALT Increase,ALT increased,10001845,Alanine aminotransferase increased,10001551,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2019-10-24,2019-12-06,42,85,
043-18101,AE,043-18101-74001-004,3,21,,Alopecia,Alopecia,10001760,Alopecia,10001760,Alopecias,10001769,Skin appendage conditions,10040798,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-11-06,,55,,ONGOING
043-18101,AE,043-18101-74001-004,4,11,"PR 1,2",Worsening Anemia,Anemia aggravated,10054309,Anaemia,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,N,DOSE NOT CHANGED,CONCURRENT PROCEDURES,RELATED,RECOVERED/RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-09-16,2019-09-20,4,8,
043-18101,AE,043-18101-74001-004,5,17,,Worsening Anemia,Anemia aggravated,10054309,Anaemia,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-10-30,,48,,ONGOING
043-18101,AE,043-18101-74001-004,6,9,,AST Increase,AST increased,10003544,Aspartate aminotransferase increased,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2019-10-04,2019-10-11,22,29,
043-18101,AE,043-18101-74001-004,7,14,,AST Increase,AST increased,10003544,Aspartate aminotransferase increased,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-10-24,,42,,ONGOING
043-18101,AE,043-18101-74001-004,8,18,,Alkaline phosphatase increase,Alkaline phosphatase increased,10001675,Blood alkaline phosphatase increased,10059570,Tissue enzyme analyses NEC,10043891,Enzyme investigations NEC,10014938,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED WITH SEQUELAE,,,,,,,MODERATE,2,TREATMENT,2019-11-06,2019-12-15,55,94,
043-18101,AE,043-18101-74001-004,9,20,,Worsening alkaline phosphatase Increase,Alkaline phosphatase increased,10001675,Blood alkaline phosphatase increased,10059570,Tissue enzyme analyses NEC,10043891,Enzyme investigations NEC,10014938,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,SEVERE,3,SAFETY FOLLOW-UP,2019-12-16,,95,,ONGOING
043-18101,AE,043-18101-74001-004,10,1,CM 1,Diarrhea,Diarrhea,10012727,Diarrhoea,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2019-09-13,2019-09-20,1,8,
043-18101,AE,043-18101-74001-004,11,7,,Diarrhea,Diarrhea,10012727,Diarrhoea,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-09-30,,18,,ONGOING
043-18101,AE,043-18101-74001-004,12,15,,Dyspnea,Dyspnea,10013963,Dyspnoea,10013968,Breathing abnormalities,10006334,Respiratory disorders NEC,10038716,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,SEVERE,3,TREATMENT,2019-10-29,,47,,ONGOING
043-18101,AE,043-18101-74001-004,13,3,,Fatigue,Fatigue,10016256,Fatigue,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2019-09-14,2019-11-07,2,56,
043-18101,AE,043-18101-74001-004,14,10,CM 26,Hypercalcemia,Hypercalcemia,10020587,Hypercalcaemia,10020583,Calcium metabolism disorders,10006975,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-10-18,2019-10-24,36,42,
043-18101,AE,043-18101-74001-004,15,22,"CM 33,34,35",Hypercalcemia,Hypercalcemia,10020587,Hypercalcaemia,10020583,Calcium metabolism disorders,10006975,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,Y,,CONCOMITANT MEDICATIONS,NOT RELATED,RECOVERING/RESOLVING,,,,Y,,,SEVERE,3,SAFETY FOLLOW-UP,2019-12-19,,98,,ONGOING
043-18101,AE,043-18101-74001-004,16,16,,Hypoxia,Hypoxia,10021143,Hypoxia,10021143,Conditions associated with abnormal gas exchange,10010268,Respiratory disorders NEC,10038716,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-10-29,,47,,ONGOING
043-18101,AE,043-18101-74001-004,17,2,"CM 2,3,4,20,24,27",Nausea,Nausea,10028813,Nausea,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-09-14,,2,,ONGOING
043-18101,AE,043-18101-74001-004,18,13,"PR 3,4",Pleural effusion,Pleural effusion,10035598,Pleural effusion,10035598,Pneumothorax and pleural effusions NEC,10035761,Pleural disorders,10035597,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Y,DOSE NOT CHANGED,CONCURRENT PROCEDURES,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,TREATMENT,2019-10-29,2019-11-01,47,50,
043-18101,AE,043-18101-74001-004,19,4,"CM 19,23",Oral mucositis,Mucositis oral,10028130,Stomatitis,10042128,Stomatitis and ulceration,10042129,Oral soft tissue conditions,10031013,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED WITH SEQUELAE,,,,,,,MILD,1,TREATMENT,2019-09-14,2019-11-05,2,54,
043-18101,AE,043-18101-74001-004,20,19,"CM 19,23",Worsening oral mucositis,Mucositis oral,10028130,Stomatitis,10042128,Stomatitis and ulceration,10042129,Oral soft tissue conditions,10031013,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-11-06,2019-11-13,55,62,
043-18101,AE,043-18101-74001-004,21,5,,Weight loss,Weight loss,10047900,Weight decreased,10047895,Physical examination procedures and organ system status,10071941,Physical examination and organ system status topics,10071940,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2019-09-18,2019-10-11,6,29,
043-18101,AE,043-18101-74001-005,1,2,,Abdominal pain,Abdominal pain,10000081,Abdominal pain,10000081,Gastrointestinal and abdominal pains (excl oral and throat),10017926,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-12-22,,4,,ONGOING
043-18101,AE,043-18101-74001-005,2,5,,Alopecia,Alopecia,10001760,Alopecia,10001760,Alopecias,10001769,Skin appendage conditions,10040798,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED WITH SEQUELAE,,,,,,,MILD,1,TREATMENT,2020-01-09,2020-01-15,22,28,
043-18101,AE,043-18101-74001-005,3,6,,Worsening Alopecia,Alopecia,10001760,Alopecia,10001760,Alopecias,10001769,Skin appendage conditions,10040798,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2020-01-16,,29,,ONGOING
043-18101,AE,043-18101-74001-005,4,3,,Bone pain,Bone pain,10006002,Bone pain,10006002,Bone related signs and symptoms,10006006,Bone disorders (excl congenital and fractures),10005959,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-05,,18,,ONGOING
043-18101,AE,043-18101-74001-005,5,8,,Bronchial Infection,Bronchial infection,10055078,Bronchitis,10006451,Lower respiratory tract and lung infections,10025101,Infections - pathogen unspecified,10021879,Infections and infestations,10021881,Infections and infestations,10021881,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MODERATE,2,TREATMENT,2020-01-10,2020-01-16,23,29,
043-18101,AE,043-18101-74001-005,6,13,,Bladder infection,Bladder infection,10005047,Cystitis,10011781,Urinary tract infections,10046577,Infections - pathogen unspecified,10021879,Infections and infestations,10021881,Infections and infestations,10021881,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MODERATE,2,TREATMENT,2020-01-28,2020-01-30,41,43,
043-18101,AE,043-18101-74001-005,7,4,,Dysesthesia,Dysesthesia,10062872,Dysaesthesia,10013886,Paraesthesias and dysaesthesias,10033788,Neurological disorders NEC,10029305,Nervous system disorders,10029205,Nervous system disorders,10029205,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-09,,22,,ONGOING
043-18101,AE,043-18101-74001-005,8,9,,Fatigue,Fatigue,10016256,Fatigue,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-16,2020-01-28,29,41,
043-18101,AE,043-18101-74001-005,9,1,,Nausea,Nausea,10028813,Nausea,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-12-21,,3,,ONGOING
043-18101,AE,043-18101-74001-005,10,7,,Neutrophil count decreased,Neutrophil count decreased,10029366,Neutrophil count decreased,10029366,White blood cell analyses,10047938,Haematology investigations (incl blood groups),10018851,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,SEVERE,3,TREATMENT,2020-01-09,2020-02-24,22,68,
043-18101,AE,043-18101-74001-005,11,12,,Fever,Fever,10016558,Pyrexia,10037660,Febrile disorders,10016286,Body temperature conditions,10005908,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-28,2020-01-29,41,42,
043-18101,AE,043-18101-74001-005,12,11,,Skin papiloma,Skin papilloma,10040907,Skin papilloma,10040907,Skin neoplasms benign,10040898,Cutaneous neoplasms benign,10040899,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2020-01-27,,40,,ONGOING
043-18101,AE,043-18101-74001-005,13,14,,Vertigo,Vertigo,10047340,Vertigo,10047340,Inner ear signs and symptoms,10022398,Inner ear and VIIIth cranial nerve disorders,10022396,Ear and labyrinth disorders,10013993,Ear and labyrinth disorders,10013993,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2020-02-01,,45,,ONGOING
043-18101,AE,043-18101-74001-005,14,10,,White blood cell decreased,White blood cell decreased,10049182,White blood cell count decreased,10047942,White blood cell analyses,10047938,Haematology investigations (incl blood groups),10018851,Investigations,10022891,Investigations,10022891,N,DOSE NOT CHANGED,NONE,,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2020-01-09,,22,,ONGOING
043-18101,AE,043-18101-74002-001,1,4,,Anemia,Anemia,10002272,Anaemia,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-11-14,2019-12-18,8,42,
043-18101,AE,043-18101-74002-001,2,5,PR 1,Anemia,Anemia,10002272,Anaemia,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,N,NOT APPLICABLE,CONCURRENT PROCEDURES,NOT RELATED,RECOVERED/RESOLVED,,,,,,,SEVERE,3,TREATMENT,2019-12-19,2020-01-03,43,58,
043-18101,AE,043-18101-74002-001,3,9,,Anemia,Anemia,10002272,Anaemia,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,SAFETY FOLLOW-UP,2020-01-04,2020-01-06,59,61,
043-18101,AE,043-18101-74002-001,4,10,,Anemia,Anemia,10002272,Anaemia,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,SAFETY FOLLOW-UP,2020-01-07,,62,,ONGOING
043-18101,AE,043-18101-74002-001,5,6,CM 11 12,Hypokalemia,Hypokalemia,10021018,Hypokalaemia,10021015,Potassium imbalance,10036451,Electrolyte and fluid balance conditions,10014412,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,NOT APPLICABLE,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,,,,MODERATE,2,TREATMENT,2019-12-04,2019-12-11,28,35,
043-18101,AE,043-18101-74002-001,6,8,CM 12,Hypokalemia,Hypokalemia,10021018,Hypokalaemia,10021015,Potassium imbalance,10036451,Electrolyte and fluid balance conditions,10014412,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-12-19,,43,,ONGOING
043-18101,AE,043-18101-74002-001,7,1,,Colonic Obstruction,Colonic obstruction,10010000,Large intestinal obstruction,10062062,Large intestinal stenosis and obstruction,10023796,Gastrointestinal stenosis and obstruction,10018008,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Y,DRUG INTERRUPTED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,TREATMENT,2019-11-23,2019-11-27,17,21,
043-18101,AE,043-18101-74002-001,8,2,,Muscle Cramp - Hands,Cramp in hand,10011287,Muscle spasms,10028334,Muscle related signs and symptoms NEC,10028326,Muscle disorders,10028302,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-11-10,,4,,ONGOING
043-18101,AE,043-18101-74002-001,9,7,,Small Bowel Obstruction,Small bowel obstruction,10041055,Small intestinal obstruction,10041101,Duodenal and small intestinal stenosis and obstruction,10013811,Gastrointestinal stenosis and obstruction,10018008,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Y,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,SAFETY FOLLOW-UP,2020-01-01,2020-01-08,56,63,
043-18101,AE,043-18101-74002-001,10,3,CM 7,Vomiting,Vomiting,10047700,Vomiting,10047700,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2019-11-11,,5,,ONGOING
043-18101,AE,043-18101-74002-002,1,1,"CM 7, 14/PR 1,2,3,4",STROKE,Stroke,10042244,Cerebrovascular accident,10008190,Central nervous system haemorrhages and cerebrovascular accidents,10007948,Central nervous system vascular disorders,10007963,Nervous system disorders,10029205,Nervous system disorders,10029205,Y,NOT APPLICABLE,MULTIPLE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,Y,,SEVERE,3,,2019-12-02,2019-12-06,,,
043-18101,AE,043-18101-74002-002,2,2,"PR 1,2,3,4",STROKE,Stroke,10042244,Cerebrovascular accident,10008190,Central nervous system haemorrhages and cerebrovascular accidents,10007948,Central nervous system vascular disorders,10007963,Nervous system disorders,10029205,Nervous system disorders,10029205,N,NOT APPLICABLE,CONCURRENT PROCEDURES,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,,2019-12-07,,,,ONGOING
043-18101,AE,043-18101-74003-001,1,1,,Upper Gastrointestinal Bleed,Upper gastrointestinal bleeding,10071910,Upper gastrointestinal haemorrhage,10046274,Non-site specific gastrointestinal haemorrhages,10017958,Gastrointestinal haemorrhages NEC,10017959,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Y,NOT APPLICABLE,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,,2019-09-29,2019-10-03,,,
043-18101,AE,043-18101-74003-002,1,1,,Small Bowel Obstruction,Small bowel obstruction,10041055,Small intestinal obstruction,10041101,Duodenal and small intestinal stenosis and obstruction,10013811,Gastrointestinal stenosis and obstruction,10018008,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Y,NOT APPLICABLE,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,,2019-10-08,2019-10-20,,,
043-18101,AE,043-18101-74003-003,1,1,,Small Bowel Obstruction,Small bowel obstruction,10041055,Small intestinal obstruction,10041101,Duodenal and small intestinal stenosis and obstruction,10013811,Gastrointestinal stenosis and obstruction,10018008,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Y,NOT APPLICABLE,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,SCREENING,2019-10-16,2019-10-21,,,
043-18101,AE,043-18101-74003-003,2,2,,Small Bowel Obstruction,Small bowel obstruction,10041055,Small intestinal obstruction,10041101,Duodenal and small intestinal stenosis and obstruction,10013811,Gastrointestinal stenosis and obstruction,10018008,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Y,NOT APPLICABLE,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,SCREENING,2019-10-23,2019-11-11,,,
043-18101,AE,043-18101-74003-004,1,1,,Right upper back pain,Upper back pain,10046273,Back pain,10003988,Musculoskeletal and connective tissue pain and discomfort,10068757,Musculoskeletal and connective tissue disorders NEC,10028393,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,N,NOT APPLICABLE,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SCREENING,2019-10-30,,-8,,ONGOING
043-18101,AE,043-18101-74003-004,2,2,,Right flank pain,Flank pain,10016750,Flank pain,10016750,Musculoskeletal and connective tissue pain and discomfort,10068757,Musculoskeletal and connective tissue disorders NEC,10028393,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,N,NOT APPLICABLE,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SCREENING,2019-10-30,,-8,,ONGOING
043-18101,AE,043-18101-74003-004,3,4,,Tongue Soreness,Tongue sore,10043980,Glossodynia,10018388,Tongue signs and symptoms,10043985,Tongue conditions,10043946,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2019-11-24,2019-12-30,18,54,
043-18101,AE,043-18101-74003-004,4,3,,Numbness to left toes,Numbness in toes,10049799,Hypoaesthesia,10020937,Paraesthesias and dysaesthesias,10033788,Neurological disorders NEC,10029305,Nervous system disorders,10029205,Nervous system disorders,10029205,N,NOT APPLICABLE,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SCREENING,2019-10-30,,-8,,ONGOING
043-18101,AE,043-18101-74003-004,5,5,,Paralysis of Left Vocal Fold,Vocal cord paralysis,10047674,Vocal cord paralysis,10047674,Vagus nerve disorders,10046967,Cranial nerve disorders (excl neoplasms),10011305,Nervous system disorders,10029205,Nervous system disorders,10029205,Y,NOT APPLICABLE,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,SAFETY FOLLOW-UP,2020-01-28,2020-01-28,83,83,
043-18101,AE,043-18101-74003-005,1,1,,Atrial Fibrillation with rapid ventricular response,Atrial fibrillation with rapid ventricular response,10058331,Atrial fibrillation,10003658,Supraventricular arrhythmias,10042600,Cardiac arrhythmias,10007521,Cardiac disorders,10007541,Cardiac disorders,10007541,Y,NOT APPLICABLE,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,,2019-11-26,2019-12-02,,,
043-18101,AE,043-18101-74003-005,2,2,,Variceal Bleed,Gastroesophageal varices hemorrhage,10068934,Oesophageal varices haemorrhage,10030210,Gastric and oesophageal haemorrhages,10017751,Gastrointestinal haemorrhages NEC,10017959,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Y,NOT APPLICABLE,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,,2019-12-06,2019-12-13,,,
043-18101,AE,043-18101-74003-006,1,1,,Malignant obstructive jaundice,Obstructive jaundice,10029982,Jaundice cholestatic,10023129,Cholestasis and jaundice,10008636,Hepatic and hepatobiliary disorders,10019654,Hepatobiliary disorders,10019805,Hepatobiliary disorders,10019805,Y,NOT APPLICABLE,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,MODERATE,2,SCREENING,2019-12-13,2019-12-15,,,
043-18101,AE,043-18101-74004-002,1,26,PR CT Scan,ALT Increased,ALT increased,10001845,Alanine aminotransferase increased,10001551,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DRUG INTERRUPTED,CONCURRENT PROCEDURES,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SAFETY FOLLOW-UP,2020-02-25,,51,,ONGOING
043-18101,AE,043-18101-74004-002,2,9,CM 11,Anxiety,Anxiety,10002855,Anxiety,10002855,Anxiety symptoms,10002869,Anxiety disorders and symptoms,10002861,Psychiatric disorders,10037175,Psychiatric disorders,10037175,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-20,,15,,ONGOING
043-18101,AE,043-18101-74004-002,3,25,PR CT Scan,AST increased,AST increased,10003544,Aspartate aminotransferase increased,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,Investigations,10022891,N,DRUG INTERRUPTED,CONCURRENT PROCEDURES,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,SAFETY FOLLOW-UP,2020-02-25,,51,,ONGOING
043-18101,AE,043-18101-74004-002,4,3,CM 14,Atrial Fibrillation,Atrial fibrillation,10003658,Atrial fibrillation,10003658,Supraventricular arrhythmias,10042600,Cardiac arrhythmias,10007521,Cardiac disorders,10007541,Cardiac disorders,10007541,Y,DRUG INTERRUPTED,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,,,Y,MODERATE,2,TREATMENT,2020-01-13,2020-01-21,8,16,
043-18101,AE,043-18101-74004-002,5,27,PR CT Scan,Alkaline phosphatase increased,Alkaline phosphatase increased,10001675,Blood alkaline phosphatase increased,10059570,Tissue enzyme analyses NEC,10043891,Enzyme investigations NEC,10014938,Investigations,10022891,Investigations,10022891,N,DRUG INTERRUPTED,CONCURRENT PROCEDURES,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SAFETY FOLLOW-UP,2020-02-25,,51,,ONGOING
043-18101,AE,043-18101-74004-002,6,22,,Bronchial Stricture,Bronchial stricture,10063524,Bronchostenosis,10006487,Bronchospasm and obstruction,10006484,Bronchial disorders (excl neoplasms),10006436,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-18,,44,,ONGOING
043-18101,AE,043-18101-74004-002,7,13,"CM 9, 12",Constipation,Constipation,10010774,Constipation,10010774,Gastrointestinal atonic and hypomotility disorders NEC,10017933,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-10,2020-02-10,5,36,
043-18101,AE,043-18101-74004-002,8,5,"CM 9, 12",intermittent Constipation,Constipation,10010774,Constipation,10010774,Gastrointestinal atonic and hypomotility disorders NEC,10017933,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-10,,5,,ONGOING
043-18101,AE,043-18101-74004-002,9,11,,Diarrhea,Diarrhea,10012727,Diarrhoea,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-24,2020-01-24,19,19,
043-18101,AE,043-18101-74004-002,10,4,,Hypermagnesemia,Hypermagnesemia,10020670,Hypermagnesaemia,10020669,Magnesium metabolism disorders,10025439,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-13,2020-01-28,8,23,
043-18101,AE,043-18101-74004-002,11,10,CM 15,Hypocalcemia,Hypocalcemia,10020949,Hypocalcaemia,10020947,Calcium metabolism disorders,10006975,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-21,2020-01-28,16,23,
043-18101,AE,043-18101-74004-002,12,21,CM 20,Hypocalcemia,Hypocalcemia,10020949,Hypocalcaemia,10020947,Calcium metabolism disorders,10006975,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-18,,44,,ONGOING
043-18101,AE,043-18101-74004-002,13,16,,Hyponatremia,Hyponatremia,10021038,Hyponatraemia,10021036,Sodium imbalance,10041273,Electrolyte and fluid balance conditions,10014412,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-10,,36,,ONGOING
043-18101,AE,043-18101-74004-002,14,6,"CM 17, 19, 21, 23, 24",Hypophosphatemia,Hypophosphatemia,10021059,Hypophosphataemia,10021058,Phosphorus metabolism disorders,10034941,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,,,,SEVERE,3,TREATMENT,2020-01-13,2020-01-21,8,16,
043-18101,AE,043-18101-74004-002,15,17,CM 17,Hypophosphatemia,Hypophosphatemia,10021059,Hypophosphataemia,10021058,Phosphorus metabolism disorders,10034941,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-21,,16,,ONGOING
043-18101,AE,043-18101-74004-002,16,7,,subclinical hypothyroidism,Subclinical hypothyroidism,10064627,Hypothyroidism,10021114,Thyroid hypofunction disorders,10043741,Thyroid gland disorders,10043739,Endocrine disorders,10014698,Endocrine disorders,10014698,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-13,,8,,ONGOING
043-18101,AE,043-18101-74004-002,17,12,"CM 22, 26",Insomnia,Insomnia,10022437,Insomnia,10022437,Disturbances in initiating and maintaining sleep,10013510,Sleep disorders and disturbances,10040991,Psychiatric disorders,10037175,Psychiatric disorders,10037175,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-21,,16,,ONGOING
043-18101,AE,043-18101-74004-002,18,15,,Leg Cramps,Leg cramps,10024125,Muscle spasms,10028334,Muscle related signs and symptoms NEC,10028326,Muscle disorders,10028302,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-06,,32,,ONGOING
043-18101,AE,043-18101-74004-002,19,19,,Muscle cramp-left calf,Muscle cramp,10028294,Muscle spasms,10028334,Muscle related signs and symptoms NEC,10028326,Muscle disorders,10028302,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-06,,32,,ONGOING
043-18101,AE,043-18101-74004-002,20,1,"CM 7, 18,27",intermittent Nausea,Nausea,10028813,Nausea,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MODERATE,2,TREATMENT,2020-01-07,,2,,ONGOING
043-18101,AE,043-18101-74004-002,21,18,CM 27,nausea,Nausea,10028813,Nausea,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-30,,25,,ONGOING
043-18101,AE,043-18101-74004-002,22,20,,Edema limbs (bilateral ankles),Ankle edema,10002542,Oedema peripheral,10030124,Oedema NEC,10030113,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-17,,43,,ONGOING
043-18101,AE,043-18101-74004-002,23,8,,Paresthesia,Paresthesia,10033987,Paraesthesia,10033775,Paraesthesias and dysaesthesias,10033788,Neurological disorders NEC,10029305,Nervous system disorders,10029205,Nervous system disorders,10029205,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-14,2020-01-25,9,20,
043-18101,AE,043-18101-74004-002,24,14,,Paresthesia-Tingling - right axilla and right hip,Tingling,10043876,Paraesthesia,10033775,Paraesthesias and dysaesthesias,10033788,Neurological disorders NEC,10029305,Nervous system disorders,10029205,Nervous system disorders,10029205,N,DOSE NOT CHANGED,NONE,NOT RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-14,2020-01-25,9,20,
043-18101,AE,043-18101-74004-002,25,24,,Platelet count decreased,Platelet count decreased,10035528,Platelet count decreased,10035528,Platelet analyses,10035523,Haematology investigations (incl blood groups),10018851,Investigations,10022891,Investigations,10022891,N,DRUG INTERRUPTED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SAFETY FOLLOW-UP,2020-02-25,,51,,ONGOING
043-18101,AE,043-18101-74004-002,26,2,,Vomiting,Vomiting,10047700,Vomiting,10047700,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-08,2020-01-08,3,3,
043-18101,AE,043-18101-74004-002,27,23,,White blood cell count decreased,White blood cell count decreased,10047942,White blood cell count decreased,10047942,White blood cell analyses,10047938,Haematology investigations (incl blood groups),10018851,Investigations,10022891,Investigations,10022891,N,DRUG INTERRUPTED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SAFETY FOLLOW-UP,2020-02-25,,51,,ONGOING
043-18101,AE,043-18101-74004-003,1,6,CM 6,Constipation,Constipation,10010774,Constipation,10010774,Gastrointestinal atonic and hypomotility disorders NEC,10017933,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-10,2020-02-11,15,16,
043-18101,AE,043-18101-74004-003,2,2,,appetite loss,Appetite lost,10003028,Decreased appetite,10061428,Appetite disorders,10003022,Appetite and general nutritional disorders,10003018,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-29,,3,,ONGOING
043-18101,AE,043-18101-74004-003,3,7,,Diarrhea,Diarrhea,10012727,Diarrhoea,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SAFETY FOLLOW-UP,2020-02-12,,17,,ONGOING
043-18101,AE,043-18101-74004-003,4,1,,belching after oric dose,Belching,10004222,Eructation,10015137,Dyspeptic signs and symptoms,10013949,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,TREATMENT,2020-01-28,,2,,ONGOING
043-18101,AE,043-18101-74004-003,5,3,,fatigue,Fatigue,10016256,Fatigue,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,N,DOSE NOT CHANGED,NONE,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-06,2020-02-10,11,15,
043-18101,AE,043-18101-74004-003,6,4,PR 1,Hemoptysis,Hemoptysis,10019523,Haemoptysis,10018964,Coughing and associated symptoms,10011233,Respiratory disorders NEC,10038716,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Y,DRUG INTERRUPTED,CONCURRENT PROCEDURES,NOT RELATED,RECOVERED/RESOLVED,,,,Y,,,SEVERE,3,SAFETY FOLLOW-UP,2020-02-13,2020-02-13,18,18,
043-18101,AE,043-18101-74004-003,7,8,,Subclinical hypothyroidism,Subclinical hypothyroidism,10064627,Hypothyroidism,10021114,Thyroid hypofunction disorders,10043741,Thyroid gland disorders,10043739,Endocrine disorders,10014698,Endocrine disorders,10014698,N,DOSE NOT CHANGED,NONE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,,,,,,,MILD,1,SAFETY FOLLOW-UP,2020-02-18,,23,,ONGOING
043-18101,AE,043-18101-74004-003,8,5,CM 5,Nausea,Nausea,10028813,Nausea,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,N,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,RELATED,RECOVERED/RESOLVED,,,,,,,MILD,1,TREATMENT,2020-02-04,2020-02-06,9,11,