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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125984682 | 12598468 | 2 | F | 20160521 | 20160908 | 20160726 | 20160909 | EXP | FR-ALLERGAN-1663907US | ALLERGAN | 21.00 | YR | M | Y | 0.00000 | 20160909 | OT | FR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125984682 | 12598468 | 1 | PS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | 50 UNITS, SINGLE | C3934 | 103000 | POWDER FOR INJECTION | QD | |||||||
| 125984682 | 12598468 | 2 | SS | LEPONEX | CLOZAPINE | 1 | Oral | 2 DF | 0 | QD | |||||||||
| 125984682 | 12598468 | 3 | SS | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 275 MG, QD | 0 | 275 | MG | QD | |||||||
| 125984682 | 12598468 | 4 | C | TRANXENE T-TAB | CLORAZEPATE DIPOTASSIUM | 1 | 10 MG, QD | U | 0 | 10 | MG | QD | |||||||
| 125984682 | 12598468 | 5 | C | RIVOTRIL | CLONAZEPAM | 1 | 9 MG, QD | U | 0 | 9 | MG | QD | |||||||
| 125984682 | 12598468 | 6 | C | ZOPICLONE | ZOPICLONE | 1 | Oral | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125984682 | 12598468 | 1 | Dystonia |
| 125984682 | 12598468 | 2 | Abnormal behaviour |
| 125984682 | 12598468 | 3 | Abnormal behaviour |
| 125984682 | 12598468 | 4 | Abnormal behaviour |
| 125984682 | 12598468 | 5 | Abnormal behaviour |
| 125984682 | 12598468 | 6 | Poor quality sleep |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125984682 | 12598468 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125984682 | 12598468 | Off label use | |
| 125984682 | 12598468 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 125984682 | 12598468 | 1 | 20160520 | 20160520 | 0 |