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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127867951 | 12786795 | 1 | I | 20160902 | 0 | 20160927 | 20160927 | DIR | FDA-CTU | 59.92 | YR | M | N | 138.60000 | KG | 20160920 | N | MD | CA | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127867951 | 12786795 | 1 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | 160MG/DAY IN THE EVENINGS DURING THE WEEK. TOTAL DOSE ADMINISTERED 1760 MG | 0 | 1760 | MG | QD |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127867951 | 12786795 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127867951 | 12786795 | Aphasia | |
| 127867951 | 12786795 | Computerised tomogram abnormal | |
| 127867951 | 12786795 | Confusional state | |
| 127867951 | 12786795 | Generalised tonic-clonic seizure | |
| 127867951 | 12786795 | Haemorrhage | |
| 127867951 | 12786795 | Loss of consciousness |
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 |
|---|---|---|---|---|---|---|
| 127867951 | 12786795 | 1 | 20160901 | 0 |