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
123055492 12305549 2 F 20160728 20160426 20160805 EXP US-DRREDDYS-USA/USA/16/0078939 DR REDDYS NOYES J, LEVINE M, BELASCO J, MOSTOUFI-MOAB S. PREMATURE EPIPHYSEAL CLOSURE OF THE LOWER EXTREMITIES CONTRIBUTING TO SHORT STATURE AFTER CIS-RETINOIC ACID THERAPY IN MEDULLOBLASTOMA: A CASE REPORT. HORM RES PAEDIATR. 2016;85(1):69-73. 9.00 YR F Y 0.00000 20160805 OT COUNTRY NOT SPECIFIED 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
123055492 12305549 1 PS isotretinoin ISOTRETINOIN 1 Unknown ELEVEN 14-DAY CYCLES (180 MG/M 2 PER DAY) OVER A 13-MONTH PERIOD FOR A CUMULATIVE DOSE OF 17,360 MG U U UNKNOWN 202099
123055492 12305549 2 SS vincristine VINCRISTINE 1 Unknown 0
123055492 12305549 3 SS LOMUSTINE. LOMUSTINE 1 Unknown 0
123055492 12305549 4 SS CISPLATIN. CISPLATIN 1 Unknown 0
123055492 12305549 5 SS CARBOPLATIN. CARBOPLATIN 1 Unknown 0
123055492 12305549 6 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Unknown 0
123055492 12305549 7 SS ETOPOSIDE. ETOPOSIDE 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
123055492 12305549 1 Medulloblastoma
123055492 12305549 2 Medulloblastoma
123055492 12305549 3 Medulloblastoma
123055492 12305549 4 Medulloblastoma
123055492 12305549 5 Medulloblastoma
123055492 12305549 6 Medulloblastoma
123055492 12305549 7 Medulloblastoma

Outcome of event

Event ID CASEID OUTC COD
123055492 12305549 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
123055492 12305549 Body height below normal
123055492 12305549 Epiphyses premature fusion
123055492 12305549 Product use issue

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

no results found

Therapies reported

no results found