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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116482953 | 11648295 | 3 | F | 20130418 | 20160701 | 20151021 | 20160706 | EXP | HU-009507513-1510HUN007578 | MERCK | 7.00 | YR | F | Y | 0.00000 | 20160706 | CN | GB | HU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116482953 | 11648295 | 1 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 100 MG FOR CYCLE 1. DOSE: 75 MG/M2 PER DAY (100 MG,DAILY) | 375 | MG/M2 | 21029 | 75 | MG/M**2 | CAPSULE | QD | ||||
| 116482953 | 11648295 | 2 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | THIS DOSE FOR CYCLE 12 (140 MG, DAILY) | 375 | MG/M2 | 21029 | 140 | MG | CAPSULE | QD | ||||
| 116482953 | 11648295 | 3 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 181 MG, QOW | 0 | 181 | MG | INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116482953 | 11648295 | 1 | Brain neoplasm malignant |
| 116482953 | 11648295 | 3 | Brain neoplasm malignant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116482953 | 11648295 | OT |
| 116482953 | 11648295 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116482953 | 11648295 | Atypical teratoid/rhabdoid tumour of CNS | |
| 116482953 | 11648295 | Proteinuria |
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 |
|---|---|---|---|---|---|---|
| 116482953 | 11648295 | 1 | 20120531 | 20120604 | 0 | |
| 116482953 | 11648295 | 2 | 20130404 | 20130408 | 0 | |
| 116482953 | 11648295 | 3 | 20120322 | 0 |