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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127961921 | 12796192 | 1 | I | 20160415 | 20160920 | 20160929 | 20160929 | EXP | AU-UCBSA-2016036625 | UCB | 4.66 | YR | M | Y | 20.00000 | KG | 20160929 | CN | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127961921 | 12796192 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 2 ML, 2X/DAY (BID) | U | U | 666 | 21505 | 2 | ML | ORAL SOLUTION | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127961921 | 12796192 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127961921 | 12796192 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127961921 | 12796192 | Abnormal behaviour | |
| 127961921 | 12796192 | Aggression | |
| 127961921 | 12796192 | Anal incontinence | |
| 127961921 | 12796192 | Anger | |
| 127961921 | 12796192 | Decreased appetite | |
| 127961921 | 12796192 | Depressed mood | |
| 127961921 | 12796192 | Homicidal ideation | |
| 127961921 | 12796192 | Nasal congestion | |
| 127961921 | 12796192 | Night sweats | |
| 127961921 | 12796192 | Pain | |
| 127961921 | 12796192 | Sleep disorder | |
| 127961921 | 12796192 | Urinary incontinence |
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 |
|---|---|---|---|---|---|---|
| 127961921 | 12796192 | 1 | 20160414 | 0 |