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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126867601 | 12686760 | 1 | I | 201512 | 20160415 | 20160825 | 20160825 | EXP | US-JAZZ-2016-US-007212 | JAZZ | 20.88 | YR | F | Y | 63.49000 | KG | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126867601 | 12686760 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 126867601 | 12686760 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126867601 | 12686760 | 3 | C | ALDACTONE | SPIRONOLACTONE | 1 | U | 0 | |||||||||||
| 126867601 | 12686760 | 4 | C | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126867601 | 12686760 | 5 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 126867601 | 12686760 | 6 | C | SAFYRAL | DROSPIRENONEETHINYL ESTRADIOLLEVOMEFOLATE CALCIUM | 1 | U | 0 | |||||||||||
| 126867601 | 12686760 | 7 | C | ZIANA | CLINDAMYCIN PHOSPHATETRETINOIN | 1 | U | 0 | |||||||||||
| 126867601 | 12686760 | 8 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126867601 | 12686760 | 1 | Hypersomnia |
| 126867601 | 12686760 | 5 | Hypersomnia |
| 126867601 | 12686760 | 8 | Acne |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126867601 | 12686760 | Dizziness | |
| 126867601 | 12686760 | Headache | |
| 126867601 | 12686760 | Inappropriate affect |
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 |
|---|---|---|---|---|---|---|
| 126867601 | 12686760 | 1 | 201512 | 201601 | 0 | |
| 126867601 | 12686760 | 2 | 201601 | 0 |