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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125859651 | 12585965 | 1 | I | 201509 | 20150917 | 20160725 | 20160725 | EXP | CA-009507513-1509CAN010770 | MERCK | 35.19 | YR | M | Y | 0.00000 | 20160725 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125859651 | 12585965 | 1 | PS | TEMODAL | TEMOZOLOMIDE | 1 | Oral | 395 MG, DAILY X 5 DAYS | 21029 | 395 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125859651 | 12585965 | 1 | Glioblastoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125859651 | 12585965 | OT |
| 125859651 | 12585965 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125859651 | 12585965 | Death | |
| 125859651 | 12585965 | Malaise | |
| 125859651 | 12585965 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125859651 | 12585965 | 1 | 20150902 | 0 |