The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
125216841 12521684 1 I 201605 20160621 20160701 20160701 EXP US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-16-01116 WESTWARD 5.00 YR F Y 0.00000 20160701 MD US US

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
125216841 12521684 1 PS THIOTEPA. THIOTEPA 1 Intravenous (not otherwise specified) 75547 110 MG QD
125216841 12521684 2 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Intravenous (not otherwise specified) 0 1080 MG
125216841 12521684 3 SS FLUDARABINE PHOSPHATE. FLUDARABINE PHOSPHATE 1 Intravenous (not otherwise specified) 0 25 MG Q4H
125216841 12521684 4 SS MYLOTARG GEMTUZUMAB OZOGAMICIN 1 Intravenous (not otherwise specified) 0 2.5 MG POWDER FOR SOLUTION FOR INJECTION
125216841 12521684 5 C ACYCLOVIR. ACYCLOVIR 1 Unknown 0
125216841 12521684 6 C DAPSONE. DAPSONE 1 Unknown 0
125216841 12521684 7 C ZOFRAN ONDANSETRON HYDROCHLORIDE 1 Unknown 0
125216841 12521684 8 C CEFEPIME CEFEPIME HYDROCHLORIDE 1 Unknown 0
125216841 12521684 9 C CEFEPIME CEFEPIME HYDROCHLORIDE 1 0
125216841 12521684 10 C CEFEPIME CEFEPIME HYDROCHLORIDE 1 0
125216841 12521684 11 C FLUCONAZOLE. FLUCONAZOLE 1 Unknown 0
125216841 12521684 12 C URSODIOL. URSODIOL 1 Unknown 0
125216841 12521684 13 C FLAGYL METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE 1 Unknown 0
125216841 12521684 14 C LORAZEPAM. LORAZEPAM 1 Unknown 0
125216841 12521684 15 C VORICONAZOLE. VORICONAZOLE 1 Unknown 0
125216841 12521684 16 C AMBISOME AMPHOTERICIN B 1 Unknown 0
125216841 12521684 17 C HYDROCORTISONE. HYDROCORTISONE 1 Unknown 0
125216841 12521684 18 C TYLENOL ACETAMINOPHEN 1 Unknown 0
125216841 12521684 19 C BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 Unknown 0
125216841 12521684 20 C BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 0
125216841 12521684 21 C AMPHOTERICIN B LIPID COMPLEX AMPHOTERICIN B 1 Unknown 0
125216841 12521684 22 C MORPHINE MORPHINE 1 Unknown 0
125216841 12521684 23 C MORPHINE MORPHINE 1 Unknown 0
125216841 12521684 24 C OXYCODONE OXYCODONE 1 Unknown 0
125216841 12521684 25 C MESNA. MESNA 1 Unknown 0
125216841 12521684 26 C MAGNESIUM SULFATE. MAGNESIUM SULFATE 1 Unknown 0
125216841 12521684 27 C LASIX FUROSEMIDE 1 Unknown 0
125216841 12521684 28 C REGLAN METOCLOPRAMIDE HYDROCHLORIDE 1 Unknown 0
125216841 12521684 29 C CYCLOSPORINE. CYCLOSPORINE 1 Unknown 0
125216841 12521684 30 C MYOPHENOLATE MOFETIL 2 Unknown 0
125216841 12521684 31 C PANTOPRAZOLE PANTOPRAZOLE SODIUM 1 Unknown 0
125216841 12521684 32 C FILGRASTIM FILGRASTIM 1 Unknown 0
125216841 12521684 33 C HYDROXYZINE HYDROXYZINEHYDROXYZINE HYDROCHLORIDE 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125216841 12521684 1 Acute myeloid leukaemia recurrent
125216841 12521684 2 Acute myeloid leukaemia recurrent
125216841 12521684 3 Acute myeloid leukaemia recurrent
125216841 12521684 4 Acute myeloid leukaemia recurrent
125216841 12521684 5 Prophylaxis
125216841 12521684 6 Prophylaxis
125216841 12521684 7 Nausea
125216841 12521684 8 Febrile neutropenia
125216841 12521684 9 Bacteraemia
125216841 12521684 10 Antibiotic prophylaxis
125216841 12521684 11 Antifungal prophylaxis
125216841 12521684 12 Diuretic therapy
125216841 12521684 13 Clostridium difficile colitis
125216841 12521684 14 Nausea
125216841 12521684 15 Antifungal prophylaxis
125216841 12521684 16 Antifungal prophylaxis
125216841 12521684 17 Prophylaxis
125216841 12521684 18 Premedication
125216841 12521684 19 Nausea
125216841 12521684 20 Premedication
125216841 12521684 21 Antifungal treatment
125216841 12521684 22 Pain
125216841 12521684 24 Pain
125216841 12521684 25 Chemotherapy
125216841 12521684 26 Hypomagnesaemia
125216841 12521684 27 Diuretic therapy
125216841 12521684 28 Nausea
125216841 12521684 29 Prophylaxis
125216841 12521684 30 Prophylaxis
125216841 12521684 31 Prophylaxis
125216841 12521684 32 Product used for unknown indication
125216841 12521684 33 Pruritus

Outcome of event

Event ID CASEID OUTC COD
125216841 12521684 LT
125216841 12521684 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125216841 12521684 Atelectasis
125216841 12521684 Blood bilirubin increased
125216841 12521684 Human bocavirus infection
125216841 12521684 Hypertension
125216841 12521684 Kidney enlargement
125216841 12521684 Pleural effusion
125216841 12521684 Pulmonary oedema
125216841 12521684 Respiratory failure
125216841 12521684 Stomatitis

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
125216841 12521684 1 20160501 20160502 0
125216841 12521684 2 20160430 20160430 0
125216841 12521684 3 20160430 20160504 0
125216841 12521684 4 20160320 20160326 0
125216841 12521684 5 20150914 0
125216841 12521684 6 20151026 20160530 0
125216841 12521684 7 20160131 0
125216841 12521684 8 20160321 0
125216841 12521684 11 20160321 20160425 0
125216841 12521684 12 20160321 0
125216841 12521684 13 20160414 20160428 0
125216841 12521684 14 20160426 0
125216841 12521684 15 20160426 0
125216841 12521684 16 20160428 0
125216841 12521684 17 20160428 20160506 0
125216841 12521684 18 20160428 20160506 0
125216841 12521684 19 20160428 0
125216841 12521684 21 20160429 20160505 0
125216841 12521684 22 20160429 20160502 0
125216841 12521684 23 20160506 0
125216841 12521684 24 20160429 20160503 0
125216841 12521684 25 20160430 0
125216841 12521684 26 20160501 20160505 0
125216841 12521684 27 20160501 20160506 0
125216841 12521684 28 20160502 0
125216841 12521684 29 20160503 0
125216841 12521684 30 20160506 0
125216841 12521684 31 20160506 0
125216841 12521684 32 20160507 0
125216841 12521684 33 20160507 0