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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127020482 | 12702048 | 2 | F | 20160217 | 20160822 | 20160831 | 20160902 | EXP | IT-009507513-1608ITA011585 | MERCK | 63.00 | YR | F | Y | 60.00000 | KG | 20160902 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127020482 | 12702048 | 1 | PS | TEMODAL | TEMOZOLOMIDE | 1 | Oral | 250 MG, QD (ONE CYCLE, 5 CONSECUTIVE DAYS) | 1250 | MG | 21029 | 250 | MG | CAPSULE | QD | ||||
| 127020482 | 12702048 | 2 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 100 MG, QD (TOTAL DAILY DOSE: 120 MG (100 MG + 20 MG HARD CAPSULE) | 4800 | MG | 0 | 100 | MG | CAPSULE | QD | ||||
| 127020482 | 12702048 | 3 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 100 MG, QD (TOTAL DOSE: 150 MG (100 MG+ 20MG+ 5MG HARD CAPSULE, TWO CYCLES, 5 CONSECUTIVE DAYS) | 4800 | MG | 0 | 100 | MG | CAPSULE | QD | ||||
| 127020482 | 12702048 | 4 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 20 MG, QD (TOTAL DAILY DOSE: 120 MG (100 MG + 20 MG HARD CAPSULE) | 740 | MG | 0 | 20 | MG | CAPSULE | QD | ||||
| 127020482 | 12702048 | 5 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | TOTAL DOSE: 150 MG (100 MG+ 20MG+ 5MG HARD CAPSULE, TWO CYCLES, 5 CONSECUTIVE DAYS EACH | 740 | MG | 0 | CAPSULE | QD | ||||||
| 127020482 | 12702048 | 6 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | TOTAL DOSE: 150 MG (100 MG+ 20MG+ 5MG HARD CAPSULE, TWO CYCLES, 5 CONSECUTIVE DAYS | 0 | CAPSULE | QD | ||||||||
| 127020482 | 12702048 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 0 | TABLET | ||||||||||
| 127020482 | 12702048 | 8 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 0 | FILM-COATED TABLET | ||||||||||
| 127020482 | 12702048 | 9 | C | PLASIL | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 0 | |||||||||||
| 127020482 | 12702048 | 10 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Oral | 0 | |||||||||||
| 127020482 | 12702048 | 11 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127020482 | 12702048 | 1 | Glioblastoma |
| 127020482 | 12702048 | 2 | Glioblastoma |
| 127020482 | 12702048 | 4 | Glioblastoma |
| 127020482 | 12702048 | 6 | Glioblastoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127020482 | 12702048 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127020482 | 12702048 | Anaemia | |
| 127020482 | 12702048 | Balance disorder | |
| 127020482 | 12702048 | Confusional state | |
| 127020482 | 12702048 | Disorientation | |
| 127020482 | 12702048 | Neutropenia | |
| 127020482 | 12702048 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 127020482 | 12702048 | 1 | 20151218 | 20151222 | 0 | |
| 127020482 | 12702048 | 2 | 20150903 | 20151009 | 0 | |
| 127020482 | 12702048 | 3 | 20151120 | 20151130 | 0 | |
| 127020482 | 12702048 | 4 | 20150903 | 20151009 | 0 | |
| 127020482 | 12702048 | 5 | 20151120 | 20151130 | 0 | |
| 127020482 | 12702048 | 6 | 20151120 | 20151130 | 0 |