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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126417681 | 12641768 | 1 | I | 20160706 | 20160803 | 20160810 | 20160810 | EXP | FR-UCBSA-2016029601 | UCB | 53.00 | YR | F | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126417681 | 12641768 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 1000 MG, UNK | 21035 | 1000 | MG | ||||||||
| 126417681 | 12641768 | 2 | SS | ARIXTRA | FONDAPARINUX SODIUM | 1 | Subcutaneous | 2.5 MG/DAY | Y | U | 0 | ||||||||
| 126417681 | 12641768 | 3 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 120 MG, 3X/DAY (TID) | U | 0 | 120 | MG | TID | |||||||
| 126417681 | 12641768 | 4 | C | MANNITOL. | MANNITOL | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126417681 | 12641768 | 1 | Product used for unknown indication |
| 126417681 | 12641768 | 2 | Phlebitis |
| 126417681 | 12641768 | 3 | Product used for unknown indication |
| 126417681 | 12641768 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126417681 | 12641768 | OT |
| 126417681 | 12641768 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126417681 | 12641768 | Brain oedema | |
| 126417681 | 12641768 | Intracranial mass | |
| 126417681 | 12641768 | Subdural haematoma | |
| 126417681 | 12641768 | Tumour haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 126417681 | 12641768 | 1 | 20160627 | 0 | ||
| 126417681 | 12641768 | 2 | 201602 | 20160706 | 0 | |
| 126417681 | 12641768 | 3 | 20160707 | 0 | ||
| 126417681 | 12641768 | 4 | 20160707 | 0 |