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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125373361 | 12537336 | 1 | I | 201601 | 20160701 | 20160707 | 20160707 | EXP | FR-UCBSA-2016025052 | UCB | 64.64 | YR | M | Y | 0.00000 | 20160707 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125373361 | 12537336 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 500 MG, 2X/DAY (BID) | Y | U | 21035 | 500 | MG | FILM-COATED TABLET | BID | ||||
| 125373361 | 12537336 | 2 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | UNK | U | U | 0 | |||||||||
| 125373361 | 12537336 | 3 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | U | 0 | |||||||||
| 125373361 | 12537336 | 4 | C | TEMODAL | TEMOZOLOMIDE | 1 | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125373361 | 12537336 | 1 | Epilepsy |
| 125373361 | 12537336 | 2 | Product used for unknown indication |
| 125373361 | 12537336 | 3 | Product used for unknown indication |
| 125373361 | 12537336 | 4 | Glioblastoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125373361 | 12537336 | LT |
| 125373361 | 12537336 | HO |
| 125373361 | 12537336 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125373361 | 12537336 | Anxiety | |
| 125373361 | 12537336 | Cyclothymic disorder | |
| 125373361 | 12537336 | Depression | |
| 125373361 | 12537336 | Intracranial pressure increased | |
| 125373361 | 12537336 | Suicidal ideation | |
| 125373361 | 12537336 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 125373361 | 12537336 | 1 | 201512 | 20160525 | 0 | |
| 125373361 | 12537336 | 2 | 2015 | 0 | ||
| 125373361 | 12537336 | 4 | 201602 | 0 |