The Safety Rates Drug Report

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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
127277611 12727761 1 I 20160831 20160909 20160909 EXP US-MYLANLABS-2016M1037397 MYLAN ANDERSON BJ, PETERSON LL. SYSTEMIC CAPILLARY LEAK SYNDROME IN A PATIENT RECEIVING ADJUVANT OXALIPLATIN FOR LOCALLY ADVANCED COLON CANCER. J-ONCOL-PHARM-PRACT 2016;22(5):725-728. 0.00 Y 0.00000 20160909 OT 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
127277611 12727761 1 PS LITHIUM. LITHIUM 1 Unknown U U 202288
127277611 12727761 2 SS OXALIPLATIN. OXALIPLATIN 1 Other 12 CYCLES Y U 0 INJECTION
127277611 12727761 3 C FOLINIC ACID LEUCOVORIN 1 Unknown RECEIVED 11 CYCLES 0
127277611 12727761 4 C FLUOROURACIL. FLUOROURACIL 1 Other RECEIVED 11 CYCLES 0
127277611 12727761 5 C ONDANSETRON ONDANSETRON 1 Unknown 0
127277611 12727761 6 C DEXAMETHASONE. DEXAMETHASONE 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127277611 12727761 1 Schizoaffective disorder
127277611 12727761 2 Product used for unknown indication
127277611 12727761 3 Adenocarcinoma of colon
127277611 12727761 4 Adenocarcinoma of colon
127277611 12727761 5 Premedication
127277611 12727761 6 Premedication

Outcome of event

Event ID CASEID OUTC COD
127277611 12727761 HO
127277611 12727761 LT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127277611 12727761 Acute kidney injury
127277611 12727761 Capillary leak syndrome
127277611 12727761 Diarrhoea
127277611 12727761 Nausea
127277611 12727761 Nephrogenic diabetes insipidus
127277611 12727761 Pulmonary oedema
127277611 12727761 Temperature intolerance

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

no results found

Therapies reported

no results found