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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126545601 | 12654560 | 1 | I | 2016 | 20160803 | 20160816 | 20160816 | EXP | FR-ANSM-NY20161183 | FR-MYLANLABS-2016M1033777 | MYLAN | 0.00 | Y | 0.00000 | 20160816 | OT | IE | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126545601 | 12654560 | 1 | PS | FONDAPARINUX | FONDAPARINUX | 1 | Subcutaneous | 2.5 MG/0.5ML, QD | Y | 21345 | 2.5 | MG | INJECTION | QD | |||||
| 126545601 | 12654560 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126545601 | 12654560 | 1 | Thrombophlebitis |
| 126545601 | 12654560 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126545601 | 12654560 | HO |
| 126545601 | 12654560 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126545601 | 12654560 | Brain oedema | |
| 126545601 | 12654560 | Intracranial mass | |
| 126545601 | 12654560 | Off label use | |
| 126545601 | 12654560 | Subdural haematoma | |
| 126545601 | 12654560 | 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 |
|---|---|---|---|---|---|---|
| 126545601 | 12654560 | 1 | 201602 | 20160706 | 0 |