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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126045611 | 12604561 | 1 | I | 20070328 | 20110120 | 20160728 | 20160728 | EXP | JP-009507513-2011SP003048 | MERCK | 15.00 | YR | F | Y | 57.00000 | KG | 20160728 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126045611 | 12604561 | 1 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 150 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 150 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 2 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 150 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 150 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 3 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 150 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 150 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 4 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 150 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 150 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 5 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 150 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 150 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 6 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 150 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 150 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 7 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 8 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 9 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 10 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 11 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 12 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 13 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 14 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 15 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 16 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 17 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 18 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 19 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 20 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 21 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 22 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 23 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 24 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 25 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 26 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 27 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 28 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 29 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 30 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 31 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 32 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 33 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 34 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 35 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 36 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 37 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 38 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 39 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 40 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 41 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 42 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 43 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 44 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 45 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 46 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 47 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 48 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 49 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 50 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200 MG/M2, QD | 750 | MG/M2 | Y | N | 21029 | 200 | MG/M**2 | CAPSULE | QD | ||
126045611 | 12604561 | 51 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | DAILY DOSE UNKNOWN, FORMULATION REPORTED AS POR | 0 | ||||||||||
126045611 | 12604561 | 52 | C | BACTRAMIN | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | MONDAY, TUESDAY AND WEDNESDAY, DAILY DOSE UNKNOWN | U | 0 | TABLET | ||||||||
126045611 | 12604561 | 53 | C | KYTRIL | GRANISETRON HYDROCHLORIDE | 1 | Oral | ADMINISTERED BEFORE TAKING TEMODAL, DOSAGE UNKNOWN | U | 0 | TABLET | ||||||||
126045611 | 12604561 | 54 | C | BAYASPIRIN | ASPIRIN | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
126045611 | 12604561 | 55 | C | CHOLEBINE | COLESTILAN CHLORIDE | 1 | Oral | UNK | U | 0 | |||||||||
126045611 | 12604561 | 56 | C | THYRADIN-S | LEVOTHYROXINE | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
126045611 | 12604561 | 57 | C | SANOREX | MAZINDOL | 1 | Oral | U | 0 | TABLET |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126045611 | 12604561 | 1 | Anaplastic astrocytoma |
126045611 | 12604561 | 52 | Antifungal prophylaxis |
126045611 | 12604561 | 53 | Prophylaxis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126045611 | 12604561 | OT |
126045611 | 12604561 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126045611 | 12604561 | Disease progression | |
126045611 | 12604561 | Herpes zoster | |
126045611 | 12604561 | Intracranial tumour haemorrhage | |
126045611 | 12604561 | Liver disorder |
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 |
---|---|---|---|---|---|---|
126045611 | 12604561 | 1 | 20061002 | 20061006 | 0 | |
126045611 | 12604561 | 2 | 20061030 | 20061103 | 0 | |
126045611 | 12604561 | 3 | 20061127 | 20061201 | 0 | |
126045611 | 12604561 | 4 | 20061218 | 20061222 | 0 | |
126045611 | 12604561 | 5 | 20070115 | 20070119 | 0 | |
126045611 | 12604561 | 6 | 20070212 | 20070216 | 0 | |
126045611 | 12604561 | 7 | 20070312 | 20070316 | 0 | |
126045611 | 12604561 | 8 | 20070416 | 20070420 | 0 | |
126045611 | 12604561 | 9 | 20070521 | 20070525 | 0 | |
126045611 | 12604561 | 10 | 20070625 | 20070629 | 0 | |
126045611 | 12604561 | 11 | 20070730 | 20070803 | 0 | |
126045611 | 12604561 | 12 | 20070827 | 20070831 | 0 | |
126045611 | 12604561 | 13 | 20070926 | 20070930 | 0 | |
126045611 | 12604561 | 14 | 20071022 | 20071026 | 0 | |
126045611 | 12604561 | 15 | 20071119 | 20071123 | 0 | |
126045611 | 12604561 | 16 | 20071217 | 20071221 | 0 | |
126045611 | 12604561 | 17 | 20080121 | 20080125 | 0 | |
126045611 | 12604561 | 18 | 20080218 | 20080222 | 0 | |
126045611 | 12604561 | 19 | 20080317 | 20080321 | 0 | |
126045611 | 12604561 | 20 | 20080421 | 20080425 | 0 | |
126045611 | 12604561 | 21 | 20080521 | 20080525 | 0 | |
126045611 | 12604561 | 22 | 20080623 | 20080627 | 0 | |
126045611 | 12604561 | 23 | 20080728 | 20080801 | 0 | |
126045611 | 12604561 | 24 | 20080828 | 20080901 | 0 | |
126045611 | 12604561 | 25 | 20080925 | 20080929 | 0 | |
126045611 | 12604561 | 26 | 20081023 | 20081027 | 0 | |
126045611 | 12604561 | 27 | 20081120 | 20081124 | 0 | |
126045611 | 12604561 | 28 | 20090202 | 20090206 | 0 | |
126045611 | 12604561 | 29 | 20090507 | 20090511 | 0 | |
126045611 | 12604561 | 30 | 20090713 | 20090717 | 0 | |
126045611 | 12604561 | 31 | 20091130 | 20091204 | 0 | |
126045611 | 12604561 | 32 | 20100201 | 20100205 | 0 | |
126045611 | 12604561 | 33 | 20100405 | 20100409 | 0 | |
126045611 | 12604561 | 34 | 20100607 | 20100611 | 0 | |
126045611 | 12604561 | 35 | 20100802 | 20100806 | 0 | |
126045611 | 12604561 | 36 | 20101018 | 20101022 | 0 | |
126045611 | 12604561 | 37 | 20101220 | 20101224 | 0 | |
126045611 | 12604561 | 38 | 20110228 | 20110304 | 0 | |
126045611 | 12604561 | 39 | 20110425 | 20110429 | 0 | |
126045611 | 12604561 | 40 | 20110606 | 20110610 | 0 | |
126045611 | 12604561 | 41 | 20110801 | 20110805 | 0 | |
126045611 | 12604561 | 42 | 20111003 | 20111007 | 0 | |
126045611 | 12604561 | 43 | 20111205 | 20111209 | 0 | |
126045611 | 12604561 | 44 | 20120206 | 20120210 | 0 | |
126045611 | 12604561 | 45 | 20120402 | 20120406 | 0 | |
126045611 | 12604561 | 46 | 20120604 | 20120608 | 0 | |
126045611 | 12604561 | 47 | 20120827 | 20120831 | 0 | |
126045611 | 12604561 | 48 | 20121029 | 20121102 | 0 | |
126045611 | 12604561 | 49 | 20121224 | 20121228 | 0 | |
126045611 | 12604561 | 50 | 20130128 | 20130201 | 0 | |
126045611 | 12604561 | 51 | 20151212 | 20160223 | 0 | |
126045611 | 12604561 | 53 | 20061002 | 0 | ||
126045611 | 12604561 | 54 | 20081122 | 0 | ||
126045611 | 12604561 | 57 | 20100428 | 0 |