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
126082971 12608297 1 I 20111026 20120927 20160729 20160729 EXP JP-009507513-1305JPN007837 MERCK 36.00 YR F Y 50.00000 KG 20160729 MD JP JP

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
126082971 12608297 1 PS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 75 MG/M2, QD 10925 MG/M2 21029 75 MG/M**2 CAPSULE QD
126082971 12608297 2 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 75 MG/M2, QD 10925 MG/M2 21029 75 MG/M**2 CAPSULE QD
126082971 12608297 3 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 4 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 200 MG/M2, QD 10925 MG/M2 21029 200 MG/M**2 CAPSULE QD
126082971 12608297 5 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 200 MG/M2, QD 10925 MG/M2 21029 200 MG/M**2 CAPSULE QD
126082971 12608297 6 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 200 MG/M2, QD 10925 MG/M2 21029 200 MG/M**2 CAPSULE QD
126082971 12608297 7 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 200 MG/M2, QD 10925 MG/M2 21029 200 MG/M**2 CAPSULE QD
126082971 12608297 8 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 200 MG/M2, QD 10925 MG/M2 21029 200 MG/M**2 CAPSULE QD
126082971 12608297 9 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 10 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 11 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 12 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 13 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 14 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 15 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 16 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 17 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 18 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 19 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 20 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 21 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Oral 150 MG/M2, QD 10925 MG/M2 21029 150 MG/M**2 CAPSULE QD
126082971 12608297 22 SS E KEPPRA LEVETIRACETAM 1 Oral DAILY DOSAGE UNKNOWN 0 TABLET
126082971 12608297 23 SS DEPAKENE VALPROIC ACID 1 Oral DAILY DOSAGE UNKNOWN U 0 TABLET
126082971 12608297 24 C BAKTAR SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral DAILY DOSAGE UNKNOWN 0 POWDER FOR ORAL SOLUTION
126082971 12608297 25 C PRIMPERAN METOCLOPRAMIDE HYDROCHLORIDE 1 Oral DAILY DOSAGE UNKNOWN 0 TABLET
126082971 12608297 26 C EMEND APREPITANT 1 Oral DAILY DOSAGE UNKNOWN 0 CAPSULE
126082971 12608297 27 C NASEA RAMOSETRON HYDROCHLORIDE 1 Oral DAILY DOSAGE UNKNOWN 0 TABLET
126082971 12608297 28 C DEXAMETHASONE. DEXAMETHASONE 1 Oral DAILY DOSAGE UNKNOWN 0 TABLET
126082971 12608297 29 C MAGLAX (magnesium oxide) MAGNESIUM OXIDE 1 Oral DAILY DOSAGE UNKNOWN 0 TABLET
126082971 12608297 30 C MYSTAN CLOBAZAM 1 Oral DAILY DOSAGE UNKNOWN 0 TABLET
126082971 12608297 31 C MUCOSTA REBAMIPIDE 1 Oral DAILY DOSAGE UNKNOWN 0 TABLET

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126082971 12608297 1 Anaplastic astrocytoma
126082971 12608297 24 Antifungal prophylaxis
126082971 12608297 25 Prophylaxis
126082971 12608297 26 Prophylaxis
126082971 12608297 27 Prophylaxis
126082971 12608297 28 Prophylaxis

Outcome of event

Event ID CASEID OUTC COD
126082971 12608297 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126082971 12608297 Hyperkalaemia
126082971 12608297 Leukopenia
126082971 12608297 Lymphocyte count decreased
126082971 12608297 Monocyte count increased
126082971 12608297 Neutropenia
126082971 12608297 Neutrophil count decreased
126082971 12608297 Platelet count decreased

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
126082971 12608297 1 20111019 20111026 0
126082971 12608297 2 20111109 20111119 0
126082971 12608297 3 20120121 20120125 0
126082971 12608297 4 20120224 20120228 0
126082971 12608297 5 20120324 20120328 0
126082971 12608297 6 20120424 20120428 0
126082971 12608297 7 20120524 20120528 0
126082971 12608297 8 20120615 20120619 0
126082971 12608297 9 20120715 20120719 0
126082971 12608297 10 20120815 20120819 0
126082971 12608297 11 20120915 20120919 0
126082971 12608297 12 20121115 20121119 0
126082971 12608297 13 20121215 20121219 0
126082971 12608297 14 20130126 20130130 0
126082971 12608297 15 20130405 20130409 0
126082971 12608297 16 20130510 20130514 0
126082971 12608297 17 20130621 20130625 0
126082971 12608297 18 20130719 20130723 0
126082971 12608297 19 20130816 20130820 0
126082971 12608297 20 20130913 20130917 0
126082971 12608297 21 20131018 20131022 0
126082971 12608297 22 20110920 20111101 0
126082971 12608297 23 20111101 0
126082971 12608297 24 20111019 20111124 0
126082971 12608297 25 20111019 20111129 0
126082971 12608297 26 20111019 20111023 0
126082971 12608297 27 20111019 20111023 0
126082971 12608297 28 20111019 20111020 0
126082971 12608297 29 20111124 0
126082971 12608297 30 20110113 20140904 0