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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94538341 | 9453834 | 1 | I | 20120118 | 20130227 | 20120321 | 20120321 | PER | US-LUNDBECK-DKLU1076916 | LUNDBECK | 2.08 | F | Y | 0.00000 | 20130925 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94538341 | 9453834 | 1 | PS | Sabril (For Oral Solution) | 1 | ORAL | D | 22006 | 1000 | MG | BID | ||||||||
| 94538341 | 9453834 | 2 | SS | Sabril (For Oral Solution) | 1 | ORAL | D | 22006 | 1500 | MG | BID | ||||||||
| 94538341 | 9453834 | 3 | C | ACTH | 1 | D | 0 | ||||||||||||
| 94538341 | 9453834 | 4 | C | VALPROIC ACID | 1 | D | 0 | ||||||||||||
| 94538341 | 9453834 | 5 | C | TOPAMAX | 1 | D | 0 | ||||||||||||
| 94538341 | 9453834 | 6 | C | PHENOBARBITAL | 1 | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 94538341 | 9453834 | 1 | Infantile spasms |
| 94538341 | 9453834 | 3 | Product used for unknown indication |
| 94538341 | 9453834 | 4 | Product used for unknown indication |
| 94538341 | 9453834 | 5 | Product used for unknown indication |
| 94538341 | 9453834 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 94538341 | 9453834 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 94538341 | 9453834 | Convulsion |
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 |
|---|---|---|---|---|---|---|
| 94538341 | 9453834 | 1 | 20110506 | 0 |