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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111696532 | 11169653 | 2 | F | 20160913 | 20150605 | 20160920 | EXP | US-JAZZ-2014-US-018114 | JAZZ | 0.00 | F | Y | 61.22000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111696532 | 11169653 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 111696532 | 11169653 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | |||||||||
| 111696532 | 11169653 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | Y | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 111696532 | 11169653 | 4 | C | NUVIGIL | ARMODAFINIL | 1 | Oral | U | 0 | ||||||||||
| 111696532 | 11169653 | 5 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | Oral | U | 0 | ||||||||||
| 111696532 | 11169653 | 6 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | U | 0 | ||||||||||
| 111696532 | 11169653 | 7 | C | ESTROGEN | ESTRONESUS SCROFA OVARY | 1 | Oral | U | 0 | ||||||||||
| 111696532 | 11169653 | 8 | C | DIOVAN | VALSARTAN | 1 | Oral | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111696532 | 11169653 | 1 | Narcolepsy |
| 111696532 | 11169653 | 2 | Somnolence |
| 111696532 | 11169653 | 3 | Cataplexy |
| 111696532 | 11169653 | 4 | Product used for unknown indication |
| 111696532 | 11169653 | 5 | Hypothyroidism |
| 111696532 | 11169653 | 6 | Hypothyroidism |
| 111696532 | 11169653 | 7 | Hormone replacement therapy |
| 111696532 | 11169653 | 8 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111696532 | 11169653 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111696532 | 11169653 | Depression | |
| 111696532 | 11169653 | Fall | |
| 111696532 | 11169653 | Hypnagogic hallucination | |
| 111696532 | 11169653 | Seizure | |
| 111696532 | 11169653 | Somnambulism | |
| 111696532 | 11169653 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 111696532 | 11169653 | 1 | 20030213 | 0 | ||
| 111696532 | 11169653 | 3 | 201404 | 2015 | 0 |