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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126733681 | 12673368 | 1 | I | 20160810 | 20160814 | 20160822 | 20160822 | EXP | US-LUNDBECK-DKLU2018070 | LUNDBECK | 3.23 | YR | M | Y | 0.00000 | 20160822 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126733681 | 12673368 | 1 | PS | SABRIL | VIGABATRIN | 1 | Oral | 22006 | 1000 | MG | POWDER FOR ORAL SOLUTION | BID | |||||||
| 126733681 | 12673368 | 2 | SS | LACTULOSE. | LACTULOSE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126733681 | 12673368 | 1 | Infantile spasms |
| 126733681 | 12673368 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126733681 | 12673368 | HO |
| 126733681 | 12673368 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126733681 | 12673368 | Drug dose omission | |
| 126733681 | 12673368 | Gastrointestinal disorder | |
| 126733681 | 12673368 | Insomnia | |
| 126733681 | 12673368 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 126733681 | 12673368 | 1 | 20141119 | 0 |