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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125575111 | 12557511 | 1 | I | 201601 | 20160419 | 20160714 | 20160714 | EXP | US-UCBSA-2016014898 | UCB | 82.90 | YR | M | Y | 0.00000 | 20160714 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125575111 | 12557511 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 1 DF (HIGHEST MG) , 2X/DAY (BID) | 89 | DF | N | U | 21035 | 1 | DF | BID | ||||
| 125575111 | 12557511 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 1 DF (REDUCED TO 2ND HIGHEST), 2X/DAY (BID) | 89 | DF | N | U | 21035 | 1 | DF | BID | ||||
| 125575111 | 12557511 | 3 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 1DF (REDUCED TO LOWEST), 2X/DAY (BID) | 89 | DF | N | U | 21035 | 1 | DF | BID | ||||
| 125575111 | 12557511 | 4 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 1DF, REDUCED TO LOWEST, ONE A DAY | 89 | DF | N | U | 21035 | 1 | DF | QD | ||||
| 125575111 | 12557511 | 5 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 1 DF, LOW MG, ONE A DAY | 89 | DF | N | U | 21035 | 1 | DF | QD | ||||
| 125575111 | 12557511 | 6 | SS | VIMPAT | LACOSAMIDE | 1 | UNK UNK, ONCE DAILY (QD) | U | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125575111 | 12557511 | 1 | Seizure |
| 125575111 | 12557511 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125575111 | 12557511 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125575111 | 12557511 | Brain neoplasm | |
| 125575111 | 12557511 | Death | |
| 125575111 | 12557511 | Diarrhoea | |
| 125575111 | 12557511 | Neoplasm | |
| 125575111 | 12557511 | Seizure | |
| 125575111 | 12557511 | 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 |
|---|---|---|---|---|---|---|
| 125575111 | 12557511 | 1 | 20141123 | 201501 | 0 | |
| 125575111 | 12557511 | 2 | 201501 | 201502 | 0 | |
| 125575111 | 12557511 | 3 | 201502 | 2015 | 0 | |
| 125575111 | 12557511 | 4 | 2015 | 20150715 | 0 | |
| 125575111 | 12557511 | 5 | 20160103 | 20160331 | 0 | |
| 125575111 | 12557511 | 6 | 20160401 | 0 |