STUDYID,USUBJID,SUBJID,SITEID,AESEQ,SAFFL,DLTEVLFL,PKEVLFL,ENRLFL,TRT01P,TRT01PN,ARMCD,ARM,ACTARMCD,ACTARM,TRTSDT,TRTEDT,TRTP,AETERM,AEDECOD,AEBODSYS,AEBDSYCD,AELLT,AELLTCD,AEPTCD,AEHLT,AEHLTCD,AEHLGT,AEHLGTCD,AESOC,AESOCCD,AESTDTC,ASTDT,ASTDTF,AEENDTC,AENDT,AENDTF,ADURN,ADURU,ASTDY,AESTDY,AENDY,AEENDY,TRTEMFL,AESER,AEREL,AERELNP,AETOX,AETOXGR,AEACN,AEACNOTH,AEACNNP,AEOUT,AEENRF,AEDISOFL,AEDISNFL,AESDTH,AEDLTFL
043-18101,043-18101-74001-001,74001-001,74001,1,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,ALT Increase,Alanine aminotransferase increased,Investigations,10022891,ALT increased,10001845,10001551,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-05-20,20MAY2019,,,,,,,13,13,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-001,74001-001,74001,2,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,AST Increase,Aspartate aminotransferase increased,Investigations,10022891,AST increased,10003544,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-05-20,20MAY2019,,,,,,,13,13,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-001,74001-001,74001,3,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Blood Bilirubin Increase,Blood bilirubin increased,Investigations,10022891,Blood bilirubin increased,10005364,10005364,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-05-17,17MAY2019,,,,,,,10,10,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-001,74001-001,74001,4,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Confusion,Confusional state,Psychiatric disorders,10037175,Confusion,10010300,10010305,Confusion and disorientation,10010301,Deliria (incl confusion),10012221,Psychiatric disorders,10037175,2019-05-17,17MAY2019,,,,,,,10,10,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-001,74001-001,74001,5,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Delirium,Delirium,Psychiatric disorders,10037175,Delirium,10012218,10012218,Deliria,10012219,Deliria (incl confusion),10012221,Psychiatric disorders,10037175,2019-05-17,17MAY2019,,,,,,,10,10,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-001,74001-001,74001,6,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Diarrhea,Diarrhoea,Gastrointestinal disorders,10017947,Diarrhea,10012727,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2019-05-18,18MAY2019,,,,,,,11,11,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-001,74001-001,74001,7,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Worsening Fatigue,Fatigue,General disorders and administration site conditions,10018065,Fatigue aggravated,10048415,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,2019-05-12,12MAY2019,,,,,,,5,5,,,Y,N,RELATED,Related,SEVERE,3,DRUG WITHDRAWN,NONE,DRUG WITHDRAWN,NOT RECOVERED/NOT RESOLVED,ONGOING,Y,Y,,Y
043-18101,043-18101-74001-001,74001-001,74001,8,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Gastroesophageal reflux disease,Gastrooesophageal reflux disease,Gastrointestinal disorders,10017947,Gastroesophageal reflux disease,10066874,10017885,Gastrointestinal atonic and hypomotility disorders NEC,10017933,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2019-05-09,09MAY2019,,,,,,,2,2,,,Y,N,RELATED,Not Related,MODERATE,2,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-001,74001-001,74001,9,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,08MAY19,19MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Vomiting,Vomiting,Gastrointestinal disorders,10017947,Vomiting,10047700,10047700,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2019-05-10,10MAY2019,,,,,,,3,3,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-002,74001-002,74001,1,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,26MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Tumor pain,Tumour pain,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,Tumor pain,10045158,10045171,Oncologic complications and emergencies,10030315,Neoplasm related morbidities,10068775,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,2019-06-24,24JUN2019,,,,,,,41,41,,,Y,N,NOT RELATED,Not Related,MODERATE,2,NOT APPLICABLE,CONCOMITANT MEDICATIONS,NOT APPLICABLE,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-003,74001-003,74001,1,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,17MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Worsening Abdominal pain,Abdominal pain,Gastrointestinal disorders,10017947,Abdominal pain aggravated,10048358,10000081,Gastrointestinal and abdominal pains (excl oral and throat),10017926,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2019-05-20,20MAY2019,,,,,,,6,6,,,Y,Y,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-003,74001-003,74001,3,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,17MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,AST Increase,Aspartate aminotransferase increased,Investigations,10022891,AST increased,10003544,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-05-20,20MAY2019,,,,,,,6,6,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-003,74001-003,74001,4,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,17MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Blood Bilirubin Increase,Blood bilirubin increased,Investigations,10022891,Blood bilirubin increased,10005364,10005364,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-05-13,13MAY2019,,2019-05-19,19MAY2019,,7,DAYS,-2,-2,5,5,,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED WITH SEQUELAE,,,,,N
043-18101,043-18101-74001-003,74001-003,74001,5,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,17MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Blood Bilirubin Increase,Blood bilirubin increased,Investigations,10022891,Blood bilirubin increased,10005364,10005364,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-05-20,20MAY2019,,,,,,,6,6,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-003,74001-003,74001,6,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,17MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Worsening Fatigue,Fatigue,General disorders and administration site conditions,10018065,Fatigue aggravated,10048415,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,2019-05-16,16MAY2019,,,,,,,2,2,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-003,74001-003,74001,8,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,17MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Laryngeal Mucositis,Laryngeal inflammation,"Respiratory, thoracic and mediastinal disorders",10038738,Laryngeal mucositis,10065880,10065735,Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms),10023819,Upper respiratory tract disorders (excl infections),10046304,"Respiratory, thoracic and mediastinal disorders",10038738,2019-05-16,16MAY2019,,2019-05-19,19MAY2019,,4,DAYS,2,2,5,5,Y,N,RELATED,Related,SEVERE,3,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,,,,,N
043-18101,043-18101-74001-003,74001-003,74001,10,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,17MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,Nausea,Nausea,Gastrointestinal disorders,10017947,Nausea,10028813,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2019-05-16,16MAY2019,,,,,,,2,2,,,Y,N,RELATED,Related,SEVERE,3,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-003,74001-003,74001,13,Y,N,Y,Y,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,1,AIRIS1,AIRIS-101 1,AIRIS1,AIRIS-101 1,15MAY19,17MAY19,AIRIS-101 240 mg QD Intermittent + nab-paclitaxel 100 mg/m^2,White blood cell decrease,White blood cell count decreased,Investigations,10022891,White blood cell decreased,10049182,10047942,White blood cell analyses,10047938,Haematology investigations (incl blood groups),10018851,Investigations,10022891,2019-05-20,20MAY2019,,2019-05-25,25MAY2019,,6,DAYS,6,6,11,11,Y,N,RELATED,Related,LIFE-THREATENING,4,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,1,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,ALT Increase,Alanine aminotransferase increased,Investigations,10022891,ALT increased,10001845,10001551,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-10-04,04OCT2019,,2019-10-11,11OCT2019,,8,DAYS,22,22,29,29,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,2,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,ALT Increase,Alanine aminotransferase increased,Investigations,10022891,ALT increased,10001845,10001551,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-10-24,24OCT2019,,2019-12-06,06DEC2019,,44,DAYS,42,42,85,85,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,3,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Alopecia,Alopecia,Skin and subcutaneous tissue disorders,10040785,Alopecia,10001760,10001760,Alopecias,10001769,Skin appendage conditions,10040798,Skin and subcutaneous tissue disorders,10040785,2019-11-06,06NOV2019,,,,,,,55,55,,,Y,N,NOT RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-004,74001-004,74001,4,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Worsening Anemia,Anaemia,Blood and lymphatic system disorders,10005329,Anemia aggravated,10054309,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,2019-09-16,16SEP2019,,2019-09-20,20SEP2019,,5,DAYS,4,4,8,8,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,CONCURRENT PROCEDURES,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,5,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Worsening Anemia,Anaemia,Blood and lymphatic system disorders,10005329,Anemia aggravated,10054309,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,2019-10-30,30OCT2019,,,,,,,48,48,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-004,74001-004,74001,6,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,AST Increase,Aspartate aminotransferase increased,Investigations,10022891,AST increased,10003544,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-10-04,04OCT2019,,2019-10-11,11OCT2019,,8,DAYS,22,22,29,29,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,7,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,AST Increase,Aspartate aminotransferase increased,Investigations,10022891,AST increased,10003544,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2019-10-24,24OCT2019,,,,,,,42,42,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-004,74001-004,74001,8,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Alkaline phosphatase increase,Blood alkaline phosphatase increased,Investigations,10022891,Alkaline phosphatase increased,10001675,10059570,Tissue enzyme analyses NEC,10043891,Enzyme investigations NEC,10014938,Investigations,10022891,2019-11-06,06NOV2019,,2019-12-15,15DEC2019,,40,DAYS,55,55,94,94,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED WITH SEQUELAE,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,9,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Worsening alkaline phosphatase Increase,Blood alkaline phosphatase increased,Investigations,10022891,Alkaline phosphatase increased,10001675,10059570,Tissue enzyme analyses NEC,10043891,Enzyme investigations NEC,10014938,Investigations,10022891,2019-12-16,16DEC2019,,,,,,,95,95,,,Y,N,NOT RELATED,Not Related,SEVERE,3,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-004,74001-004,74001,10,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Diarrhea,Diarrhoea,Gastrointestinal disorders,10017947,Diarrhea,10012727,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2019-09-13,13SEP2019,,2019-09-20,20SEP2019,,8,DAYS,1,1,8,8,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,11,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Diarrhea,Diarrhoea,Gastrointestinal disorders,10017947,Diarrhea,10012727,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2019-09-30,30SEP2019,,,,,,,18,18,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-004,74001-004,74001,12,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Dyspnea,Dyspnoea,"Respiratory, thoracic and mediastinal disorders",10038738,Dyspnea,10013963,10013968,Breathing abnormalities,10006334,Respiratory disorders NEC,10038716,"Respiratory, thoracic and mediastinal disorders",10038738,2019-10-29,29OCT2019,,,,,,,47,47,,,Y,N,NOT RELATED,Not Related,SEVERE,3,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-004,74001-004,74001,13,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Fatigue,Fatigue,General disorders and administration site conditions,10018065,Fatigue,10016256,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,2019-09-14,14SEP2019,,2019-11-07,07NOV2019,,55,DAYS,2,2,56,56,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,14,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Hypercalcemia,Hypercalcaemia,Metabolism and nutrition disorders,10027433,Hypercalcemia,10020587,10020583,Calcium metabolism disorders,10006975,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,2019-10-18,18OCT2019,,2019-10-24,24OCT2019,,7,DAYS,36,36,42,42,Y,N,NOT RELATED,Not Related,MODERATE,2,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,16,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Hypoxia,Hypoxia,"Respiratory, thoracic and mediastinal disorders",10038738,Hypoxia,10021143,10021143,Conditions associated with abnormal gas exchange,10010268,Respiratory disorders NEC,10038716,"Respiratory, thoracic and mediastinal disorders",10038738,2019-10-29,29OCT2019,,,,,,,47,47,,,Y,N,NOT RELATED,Not Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-004,74001-004,74001,17,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Nausea,Nausea,Gastrointestinal disorders,10017947,Nausea,10028813,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2019-09-14,14SEP2019,,,,,,,2,2,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-004,74001-004,74001,19,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Oral mucositis,Stomatitis,Gastrointestinal disorders,10017947,Mucositis oral,10028130,10042128,Stomatitis and ulceration,10042129,Oral soft tissue conditions,10031013,Gastrointestinal disorders,10017947,2019-09-14,14SEP2019,,2019-11-05,05NOV2019,,53,DAYS,2,2,54,54,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED WITH SEQUELAE,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,20,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Worsening oral mucositis,Stomatitis,Gastrointestinal disorders,10017947,Mucositis oral,10028130,10042128,Stomatitis and ulceration,10042129,Oral soft tissue conditions,10031013,Gastrointestinal disorders,10017947,2019-11-06,06NOV2019,,2019-11-13,13NOV2019,,8,DAYS,55,55,62,62,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-004,74001-004,74001,21,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,13SEP19,22NOV19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Weight loss,Weight decreased,Investigations,10022891,Weight loss,10047900,10047895,Physical examination procedures and organ system status,10071941,Physical examination and organ system status topics,10071940,Investigations,10022891,2019-09-18,18SEP2019,,2019-10-11,11OCT2019,,24,DAYS,6,6,29,29,Y,N,RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-005,74001-005,74001,1,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Abdominal pain,Abdominal pain,Gastrointestinal disorders,10017947,Abdominal pain,10000081,10000081,Gastrointestinal and abdominal pains (excl oral and throat),10017926,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2019-12-22,22DEC2019,,,,,,,4,4,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-005,74001-005,74001,2,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Alopecia,Alopecia,Skin and subcutaneous tissue disorders,10040785,Alopecia,10001760,10001760,Alopecias,10001769,Skin appendage conditions,10040798,Skin and subcutaneous tissue disorders,10040785,2020-01-09,09JAN2020,,2020-01-15,15JAN2020,,7,DAYS,22,22,28,28,Y,N,NOT RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED WITH SEQUELAE,,,,,N
043-18101,043-18101-74001-005,74001-005,74001,3,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Worsening Alopecia,Alopecia,Skin and subcutaneous tissue disorders,10040785,Alopecia,10001760,10001760,Alopecias,10001769,Skin appendage conditions,10040798,Skin and subcutaneous tissue disorders,10040785,2020-01-16,16JAN2020,,,,,,,29,29,,,Y,N,NOT RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-005,74001-005,74001,4,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Bone pain,Bone pain,Musculoskeletal and connective tissue disorders,10028395,Bone pain,10006002,10006002,Bone related signs and symptoms,10006006,Bone disorders (excl congenital and fractures),10005959,Musculoskeletal and connective tissue disorders,10028395,2020-01-05,05JAN2020,,,,,,,18,18,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-005,74001-005,74001,5,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Bronchial Infection,Bronchitis,Infections and infestations,10021881,Bronchial infection,10055078,10006451,Lower respiratory tract and lung infections,10025101,Infections - pathogen unspecified,10021879,Infections and infestations,10021881,2020-01-10,10JAN2020,,2020-01-16,16JAN2020,,7,DAYS,23,23,29,29,Y,N,NOT RELATED,Not Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-005,74001-005,74001,6,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Bladder infection,Cystitis,Infections and infestations,10021881,Bladder infection,10005047,10011781,Urinary tract infections,10046577,Infections - pathogen unspecified,10021879,Infections and infestations,10021881,2020-01-28,28JAN2020,,2020-01-30,30JAN2020,,3,DAYS,41,41,43,43,Y,N,NOT RELATED,Not Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-005,74001-005,74001,7,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Dysesthesia,Dysaesthesia,Nervous system disorders,10029205,Dysesthesia,10062872,10013886,Paraesthesias and dysaesthesias,10033788,Neurological disorders NEC,10029305,Nervous system disorders,10029205,2020-01-09,09JAN2020,,,,,,,22,22,,,Y,N,NOT RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-005,74001-005,74001,8,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Fatigue,Fatigue,General disorders and administration site conditions,10018065,Fatigue,10016256,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,2020-01-16,16JAN2020,,2020-01-28,28JAN2020,,13,DAYS,29,29,41,41,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-005,74001-005,74001,9,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Nausea,Nausea,Gastrointestinal disorders,10017947,Nausea,10028813,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2019-12-21,21DEC2019,,,,,,,3,3,,,Y,N,RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-005,74001-005,74001,10,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Neutrophil count decreased,Neutrophil count decreased,Investigations,10022891,Neutrophil count decreased,10029366,10029366,White blood cell analyses,10047938,Haematology investigations (incl blood groups),10018851,Investigations,10022891,2020-01-09,09JAN2020,,2020-02-24,24FEB2020,,47,DAYS,22,22,68,68,Y,N,RELATED,Related,SEVERE,3,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-005,74001-005,74001,11,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Fever,Pyrexia,General disorders and administration site conditions,10018065,Fever,10016558,10037660,Febrile disorders,10016286,Body temperature conditions,10005908,General disorders and administration site conditions,10018065,2020-01-28,28JAN2020,,2020-01-29,29JAN2020,,2,DAYS,41,41,42,42,Y,N,RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74001-005,74001-005,74001,12,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Skin papiloma,Skin papilloma,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,Skin papilloma,10040907,10040907,Skin neoplasms benign,10040898,Cutaneous neoplasms benign,10040899,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,2020-01-27,27JAN2020,,,,,,,40,40,,,Y,N,NOT RELATED,Not Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-005,74001-005,74001,13,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Vertigo,Vertigo,Ear and labyrinth disorders,10013993,Vertigo,10047340,10047340,Inner ear signs and symptoms,10022398,Inner ear and VIIIth cranial nerve disorders,10022396,Ear and labyrinth disorders,10013993,2020-02-01,01FEB2020,,,,,,,45,45,,,Y,N,NOT RELATED,Not Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74001-005,74001-005,74001,14,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,19DEC19,,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,White blood cell decreased,White blood cell count decreased,Investigations,10022891,White blood cell decreased,10049182,10047942,White blood cell analyses,10047938,Haematology investigations (incl blood groups),10018851,Investigations,10022891,2020-01-09,09JAN2020,,,,,,,22,22,,,Y,N,,,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74002-001,74002-001,74002,1,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,23DEC19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Anemia,Anaemia,Blood and lymphatic system disorders,10005329,Anemia,10002272,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,2019-11-14,14NOV2019,,2019-12-18,18DEC2019,,35,DAYS,8,8,42,42,Y,N,NOT RELATED,Not Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74002-001,74002-001,74002,2,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,23DEC19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Anemia,Anaemia,Blood and lymphatic system disorders,10005329,Anemia,10002272,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,2019-12-19,19DEC2019,,2020-01-03,03JAN2020,,16,DAYS,43,43,58,58,Y,N,NOT RELATED,Related,SEVERE,3,NOT APPLICABLE,CONCURRENT PROCEDURES,NOT APPLICABLE,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74002-001,74002-001,74002,3,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,23DEC19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Anemia,Anaemia,Blood and lymphatic system disorders,10005329,Anemia,10002272,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,2020-01-04,04JAN2020,,2020-01-06,06JAN2020,,3,DAYS,59,59,61,61,Y,N,NOT RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74002-001,74002-001,74002,4,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,23DEC19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Anemia,Anaemia,Blood and lymphatic system disorders,10005329,Anemia,10002272,10002034,Anaemias NEC,10002067,Anaemias nonhaemolytic and marrow depression,10002086,Blood and lymphatic system disorders,10005329,2020-01-07,07JAN2020,,,,,,,62,62,,,Y,N,NOT RELATED,Related,MODERATE,2,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74002-001,74002-001,74002,5,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,23DEC19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Hypokalemia,Hypokalaemia,Metabolism and nutrition disorders,10027433,Hypokalemia,10021018,10021015,Potassium imbalance,10036451,Electrolyte and fluid balance conditions,10014412,Metabolism and nutrition disorders,10027433,2019-12-04,04DEC2019,,2019-12-11,11DEC2019,,8,DAYS,28,28,35,35,Y,N,RELATED,Related,MODERATE,2,NOT APPLICABLE,CONCOMITANT MEDICATIONS,NOT APPLICABLE,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74002-001,74002-001,74002,6,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,23DEC19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Hypokalemia,Hypokalaemia,Metabolism and nutrition disorders,10027433,Hypokalemia,10021018,10021015,Potassium imbalance,10036451,Electrolyte and fluid balance conditions,10014412,Metabolism and nutrition disorders,10027433,2019-12-19,19DEC2019,,,,,,,43,43,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74002-001,74002-001,74002,8,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,23DEC19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Muscle Cramp - Hands,Muscle spasms,Musculoskeletal and connective tissue disorders,10028395,Cramp in hand,10011287,10028334,Muscle related signs and symptoms NEC,10028326,Muscle disorders,10028302,Musculoskeletal and connective tissue disorders,10028395,2019-11-10,10NOV2019,,,,,,,4,4,,,Y,N,NOT RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74002-001,74002-001,74002,10,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,23DEC19,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Vomiting,Vomiting,Gastrointestinal disorders,10017947,Vomiting,10047700,10047700,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2019-11-11,11NOV2019,,,,,,,5,5,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74002-002,74002-002,74002,2,N,N,N,N,,,SCRNFAIL,Screen Failure,SCRNFAIL,Screen Failure,,,,STROKE,Cerebrovascular accident,Nervous system disorders,10029205,Stroke,10042244,10008190,Central nervous system haemorrhages and cerebrovascular accidents,10007948,Central nervous system vascular disorders,10007963,Nervous system disorders,10029205,2019-12-07,07DEC2019,,,,,,,,,,,,N,NOT RELATED,Not Related,MODERATE,2,NOT APPLICABLE,CONCURRENT PROCEDURES,NOT APPLICABLE,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74003-004,74003-004,74003,1,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,12JAN20,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Right upper back pain,Back pain,Musculoskeletal and connective tissue disorders,10028395,Upper back pain,10046273,10003988,Musculoskeletal and connective tissue pain and discomfort,10068757,Musculoskeletal and connective tissue disorders NEC,10028393,Musculoskeletal and connective tissue disorders,10028395,2019-10-30,30OCT2019,,,,,,,-8,-8,,,,N,NOT RELATED,Not Related,MILD,1,NOT APPLICABLE,NONE,NOT APPLICABLE,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74003-004,74003-004,74003,2,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,12JAN20,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Right flank pain,Flank pain,Musculoskeletal and connective tissue disorders,10028395,Flank pain,10016750,10016750,Musculoskeletal and connective tissue pain and discomfort,10068757,Musculoskeletal and connective tissue disorders NEC,10028393,Musculoskeletal and connective tissue disorders,10028395,2019-10-30,30OCT2019,,,,,,,-8,-8,,,,N,NOT RELATED,Not Related,MILD,1,NOT APPLICABLE,NONE,NOT APPLICABLE,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74003-004,74003-004,74003,3,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,12JAN20,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Tongue Soreness,Glossodynia,Gastrointestinal disorders,10017947,Tongue sore,10043980,10018388,Tongue signs and symptoms,10043985,Tongue conditions,10043946,Gastrointestinal disorders,10017947,2019-11-24,24NOV2019,,2019-12-30,30DEC2019,,37,DAYS,18,18,54,54,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74003-004,74003-004,74003,4,Y,Y,Y,Y,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,2,AIRIS1A,AIRIS-101 1A,AIRIS1A,AIRIS-101 1A,07NOV19,12JAN20,AIRIS-101 80 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Numbness to left toes,Hypoaesthesia,Nervous system disorders,10029205,Numbness in toes,10049799,10020937,Paraesthesias and dysaesthesias,10033788,Neurological disorders NEC,10029305,Nervous system disorders,10029205,2019-10-30,30OCT2019,,,,,,,-8,-8,,,,N,NOT RELATED,Not Related,MILD,1,NOT APPLICABLE,NONE,NOT APPLICABLE,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,1,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,ALT Increased,Alanine aminotransferase increased,Investigations,10022891,ALT increased,10001845,10001551,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2020-02-25,25FEB2020,,,,,,,51,51,,,Y,N,RELATED,Related,MILD,1,DRUG INTERRUPTED,CONCURRENT PROCEDURES,DRUG INTERRUPTED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,2,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Anxiety,Anxiety,Psychiatric disorders,10037175,Anxiety,10002855,10002855,Anxiety symptoms,10002869,Anxiety disorders and symptoms,10002861,Psychiatric disorders,10037175,2020-01-20,20JAN2020,,,,,,,15,15,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,3,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,AST increased,Aspartate aminotransferase increased,Investigations,10022891,AST increased,10003544,10003481,Liver function analyses,10024689,Hepatobiliary investigations,10019809,Investigations,10022891,2020-02-25,25FEB2020,,,,,,,51,51,,,Y,N,RELATED,Related,MODERATE,2,DRUG INTERRUPTED,CONCURRENT PROCEDURES,DRUG INTERRUPTED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,5,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Alkaline phosphatase increased,Blood alkaline phosphatase increased,Investigations,10022891,Alkaline phosphatase increased,10001675,10059570,Tissue enzyme analyses NEC,10043891,Enzyme investigations NEC,10014938,Investigations,10022891,2020-02-25,25FEB2020,,,,,,,51,51,,,Y,N,RELATED,Related,MILD,1,DRUG INTERRUPTED,CONCURRENT PROCEDURES,DRUG INTERRUPTED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,6,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Bronchial Stricture,Bronchostenosis,"Respiratory, thoracic and mediastinal disorders",10038738,Bronchial stricture,10063524,10006487,Bronchospasm and obstruction,10006484,Bronchial disorders (excl neoplasms),10006436,"Respiratory, thoracic and mediastinal disorders",10038738,2020-02-18,18FEB2020,,,,,,,44,44,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,7,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Constipation,Constipation,Gastrointestinal disorders,10017947,Constipation,10010774,10010774,Gastrointestinal atonic and hypomotility disorders NEC,10017933,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2020-01-10,10JAN2020,,2020-02-10,10FEB2020,,32,DAYS,5,5,36,36,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-002,74004-002,74004,8,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,intermittent Constipation,Constipation,Gastrointestinal disorders,10017947,Constipation,10010774,10010774,Gastrointestinal atonic and hypomotility disorders NEC,10017933,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2020-01-10,10JAN2020,,,,,,,5,5,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,9,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Diarrhea,Diarrhoea,Gastrointestinal disorders,10017947,Diarrhea,10012727,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2020-01-24,24JAN2020,,2020-01-24,24JAN2020,,1,DAYS,19,19,19,19,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-002,74004-002,74004,10,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Hypermagnesemia,Hypermagnesaemia,Metabolism and nutrition disorders,10027433,Hypermagnesemia,10020670,10020669,Magnesium metabolism disorders,10025439,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,2020-01-13,13JAN2020,,2020-01-28,28JAN2020,,16,DAYS,8,8,23,23,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-002,74004-002,74004,11,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Hypocalcemia,Hypocalcaemia,Metabolism and nutrition disorders,10027433,Hypocalcemia,10020949,10020947,Calcium metabolism disorders,10006975,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,2020-01-21,21JAN2020,,2020-01-28,28JAN2020,,8,DAYS,16,16,23,23,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-002,74004-002,74004,12,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Hypocalcemia,Hypocalcaemia,Metabolism and nutrition disorders,10027433,Hypocalcemia,10020949,10020947,Calcium metabolism disorders,10006975,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,2020-02-18,18FEB2020,,,,,,,44,44,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,13,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Hyponatremia,Hyponatraemia,Metabolism and nutrition disorders,10027433,Hyponatremia,10021038,10021036,Sodium imbalance,10041273,Electrolyte and fluid balance conditions,10014412,Metabolism and nutrition disorders,10027433,2020-02-10,10FEB2020,,,,,,,36,36,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,14,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Hypophosphatemia,Hypophosphataemia,Metabolism and nutrition disorders,10027433,Hypophosphatemia,10021059,10021058,Phosphorus metabolism disorders,10034941,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,2020-01-13,13JAN2020,,2020-01-21,21JAN2020,,9,DAYS,8,8,16,16,Y,N,RELATED,Related,SEVERE,3,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-002,74004-002,74004,15,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Hypophosphatemia,Hypophosphataemia,Metabolism and nutrition disorders,10027433,Hypophosphatemia,10021059,10021058,Phosphorus metabolism disorders,10034941,"Bone, calcium, magnesium and phosphorus metabolism disorders",10013296,Metabolism and nutrition disorders,10027433,2020-01-21,21JAN2020,,,,,,,16,16,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,16,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,subclinical hypothyroidism,Hypothyroidism,Endocrine disorders,10014698,Subclinical hypothyroidism,10064627,10021114,Thyroid hypofunction disorders,10043741,Thyroid gland disorders,10043739,Endocrine disorders,10014698,2020-01-13,13JAN2020,,,,,,,8,8,,,Y,N,NOT RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,17,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Insomnia,Insomnia,Psychiatric disorders,10037175,Insomnia,10022437,10022437,Disturbances in initiating and maintaining sleep,10013510,Sleep disorders and disturbances,10040991,Psychiatric disorders,10037175,2020-01-21,21JAN2020,,,,,,,16,16,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,18,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Leg Cramps,Muscle spasms,Musculoskeletal and connective tissue disorders,10028395,Leg cramps,10024125,10028334,Muscle related signs and symptoms NEC,10028326,Muscle disorders,10028302,Musculoskeletal and connective tissue disorders,10028395,2020-02-06,06FEB2020,,,,,,,32,32,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,19,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Muscle cramp-left calf,Muscle spasms,Musculoskeletal and connective tissue disorders,10028395,Muscle cramp,10028294,10028334,Muscle related signs and symptoms NEC,10028326,Muscle disorders,10028302,Musculoskeletal and connective tissue disorders,10028395,2020-02-06,06FEB2020,,,,,,,32,32,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,20,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,intermittent Nausea,Nausea,Gastrointestinal disorders,10017947,Nausea,10028813,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2020-01-07,07JAN2020,,,,,,,2,2,,,Y,N,RELATED,Related,MODERATE,2,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,21,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,nausea,Nausea,Gastrointestinal disorders,10017947,Nausea,10028813,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2020-01-30,30JAN2020,,,,,,,25,25,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,22,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Edema limbs (bilateral ankles),Oedema peripheral,General disorders and administration site conditions,10018065,Ankle edema,10002542,10030124,Oedema NEC,10030113,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,2020-02-17,17FEB2020,,,,,,,43,43,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,23,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Paresthesia,Paraesthesia,Nervous system disorders,10029205,Paresthesia,10033987,10033775,Paraesthesias and dysaesthesias,10033788,Neurological disorders NEC,10029305,Nervous system disorders,10029205,2020-01-14,14JAN2020,,2020-01-25,25JAN2020,,12,DAYS,9,9,20,20,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-002,74004-002,74004,24,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Paresthesia-Tingling - right axilla and right hip,Paraesthesia,Nervous system disorders,10029205,Tingling,10043876,10033775,Paraesthesias and dysaesthesias,10033788,Neurological disorders NEC,10029305,Nervous system disorders,10029205,2020-01-14,14JAN2020,,2020-01-25,25JAN2020,,12,DAYS,9,9,20,20,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-002,74004-002,74004,25,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Platelet count decreased,Platelet count decreased,Investigations,10022891,Platelet count decreased,10035528,10035528,Platelet analyses,10035523,Haematology investigations (incl blood groups),10018851,Investigations,10022891,2020-02-25,25FEB2020,,,,,,,51,51,,,Y,N,RELATED,Related,MILD,1,DRUG INTERRUPTED,NONE,DRUG INTERRUPTED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-002,74004-002,74004,26,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,Vomiting,Vomiting,Gastrointestinal disorders,10017947,Vomiting,10047700,10047700,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2020-01-08,08JAN2020,,2020-01-08,08JAN2020,,1,DAYS,3,3,3,3,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-002,74004-002,74004,27,Y,Y,Y,Y,,,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,06JAN20,22FEB20,,White blood cell count decreased,White blood cell count decreased,Investigations,10022891,White blood cell count decreased,10047942,10047942,White blood cell analyses,10047938,Haematology investigations (incl blood groups),10018851,Investigations,10022891,2020-02-25,25FEB2020,,,,,,,51,51,,,Y,N,RELATED,Related,MILD,1,DRUG INTERRUPTED,NONE,DRUG INTERRUPTED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-003,74004-003,74004,1,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,27JAN20,12FEB20,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Constipation,Constipation,Gastrointestinal disorders,10017947,Constipation,10010774,10010774,Gastrointestinal atonic and hypomotility disorders NEC,10017933,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2020-02-10,10FEB2020,,2020-02-11,11FEB2020,,2,DAYS,15,15,16,16,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-003,74004-003,74004,2,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,27JAN20,12FEB20,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,appetite loss,Decreased appetite,Metabolism and nutrition disorders,10027433,Appetite lost,10003028,10061428,Appetite disorders,10003022,Appetite and general nutritional disorders,10003018,Metabolism and nutrition disorders,10027433,2020-01-29,29JAN2020,,,,,,,3,3,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-003,74004-003,74004,3,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,27JAN20,12FEB20,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Diarrhea,Diarrhoea,Gastrointestinal disorders,10017947,Diarrhea,10012727,10012735,Diarrhoea (excl infective),10012736,Gastrointestinal motility and defaecation conditions,10017977,Gastrointestinal disorders,10017947,2020-02-12,12FEB2020,,,,,,,17,17,,,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-003,74004-003,74004,4,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,27JAN20,12FEB20,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,belching after oric dose,Eructation,Gastrointestinal disorders,10017947,Belching,10004222,10015137,Dyspeptic signs and symptoms,10013949,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2020-01-28,28JAN2020,,,,,,,2,2,,,Y,N,NOT RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-003,74004-003,74004,5,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,27JAN20,12FEB20,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,fatigue,Fatigue,General disorders and administration site conditions,10018065,Fatigue,10016256,10016256,Asthenic conditions,10003550,General system disorders NEC,10018073,General disorders and administration site conditions,10018065,2020-02-06,06FEB2020,,2020-02-10,10FEB2020,,5,DAYS,11,11,15,15,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N
043-18101,043-18101-74004-003,74004-003,74004,7,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,27JAN20,12FEB20,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Subclinical hypothyroidism,Hypothyroidism,Endocrine disorders,10014698,Subclinical hypothyroidism,10064627,10021114,Thyroid hypofunction disorders,10043741,Thyroid gland disorders,10043739,Endocrine disorders,10014698,2020-02-18,18FEB2020,,,,,,,23,23,,,Y,N,NOT RELATED,Not Related,MILD,1,DOSE NOT CHANGED,NONE,DOSE NOT CHANGED,NOT RECOVERED/NOT RESOLVED,ONGOING,,,,N
043-18101,043-18101-74004-003,74004-003,74004,8,Y,Y,Y,Y,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,3,AIRIS2A,AIRIS-101 2A,AIRIS2A,AIRIS-101 2A,27JAN20,12FEB20,AIRIS-101 160 mg QD Intermittent + nab-paclitaxel 75 mg/m^2,Nausea,Nausea,Gastrointestinal disorders,10017947,Nausea,10028813,10028813,Nausea and vomiting symptoms,10028817,Gastrointestinal signs and symptoms,10018012,Gastrointestinal disorders,10017947,2020-02-04,04FEB2020,,2020-02-06,06FEB2020,,3,DAYS,9,9,11,11,Y,N,RELATED,Related,MILD,1,DOSE NOT CHANGED,CONCOMITANT MEDICATIONS,DOSE NOT CHANGED,RECOVERED/RESOLVED,,,,,N