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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124994033 | 12499403 | 3 | F | 2013 | 20160628 | 20160627 | 20160705 | EXP | BR-ABBVIE-16P-020-1660723-00 | ABBVIE | 30.31 | YR | F | Y | 66.00000 | KG | 20160705 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124994033 | 12499403 | 1 | PS | DEPAKENE | VALPROIC ACID | 1 | Oral | UNKNOWN | 18081 | 500 | MG | TABLET | TID | ||||||
| 124994033 | 12499403 | 2 | SS | DEPAKOTE ER | DIVALPROEX SODIUM | 1 | Oral | NIGHT | UNKNOWN | 21168 | 500 | MG | COATED TABLET | QD | |||||
| 124994033 | 12499403 | 3 | SS | DEPAKOTE ER | DIVALPROEX SODIUM | 1 | Oral | MORNING | UNKNOWN | 21168 | 500 | MG | COATED TABLET | QD | |||||
| 124994033 | 12499403 | 4 | C | LAMITOR | LAMOTRIGINE | 1 | 0 | ||||||||||||
| 124994033 | 12499403 | 5 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124994033 | 12499403 | 1 | Seizure |
| 124994033 | 12499403 | 2 | Seizure |
| 124994033 | 12499403 | 4 | Product used for unknown indication |
| 124994033 | 12499403 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124994033 | 12499403 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124994033 | 12499403 | Asthenia | |
| 124994033 | 12499403 | Drug dose omission | |
| 124994033 | 12499403 | Fall | |
| 124994033 | 12499403 | Fatigue | |
| 124994033 | 12499403 | Increased appetite | |
| 124994033 | 12499403 | Loss of libido | |
| 124994033 | 12499403 | Pollakiuria | |
| 124994033 | 12499403 | Poor quality sleep | |
| 124994033 | 12499403 | Product size issue | |
| 124994033 | 12499403 | Swelling | |
| 124994033 | 12499403 | Therapy cessation | |
| 124994033 | 12499403 | Weight increased | |
| 124994033 | 12499403 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 124994033 | 12499403 | 1 | 2013 | 0 | ||
| 124994033 | 12499403 | 2 | 20160217 | 201606 | 0 | |
| 124994033 | 12499403 | 3 | 20160604 | 0 | ||
| 124994033 | 12499403 | 4 | 2015 | 2016 | 0 | |
| 124994033 | 12499403 | 5 | 2015 | 2016 | 0 |