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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127172731 | 12717273 | 1 | I | 20160813 | 0 | 20160902 | 20160902 | DIR | US-FDA-349725 | FDA-CTU | 33.00 | YR | F | N | 67.50000 | KG | 20160902 | N | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127172731 | 12717273 | 1 | PS | ONFI | CLOBAZAM | 1 | Oral | N | N | 1503745A | 20190301 | 0 | 1.5 | DF | COATED TABLET | BID | |||
| 127172731 | 12717273 | 2 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | 0 | ||||||||||||
| 127172731 | 12717273 | 3 | C | KLONOPIN | CLONAZEPAM | 1 | 0 | ||||||||||||
| 127172731 | 12717273 | 5 | C | CARBATROL | CARBAMAZEPINE | 1 | 0 | ||||||||||||
| 127172731 | 12717273 | 7 | C | LEVOTHYROXIN | LEVOTHYROXINE | 1 | 0 | ||||||||||||
| 127172731 | 12717273 | 9 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 127172731 | 12717273 | 11 | C | CALCIUM | CALCIUM | 1 | 0 | ||||||||||||
| 127172731 | 12717273 | 13 | C | DAILY MULTI-VITAMINS | 2 | 0 | |||||||||||||
| 127172731 | 12717273 | 15 | C | CBD OIL | CANNABIDIOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127172731 | 12717273 | 1 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127172731 | 12717273 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127172731 | 12717273 | Abnormal behaviour | |
| 127172731 | 12717273 | Agitation | |
| 127172731 | 12717273 | Balance disorder | |
| 127172731 | 12717273 | Constipation | |
| 127172731 | 12717273 | Decreased appetite | |
| 127172731 | 12717273 | Depressed level of consciousness | |
| 127172731 | 12717273 | Drug interaction | |
| 127172731 | 12717273 | Fatigue | |
| 127172731 | 12717273 | Immobile | |
| 127172731 | 12717273 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 127172731 | 12717273 | 1 | 20160713 | 0 |