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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125383771 | 12538377 | 1 | I | 201603 | 20160629 | 20160707 | 20160707 | EXP | US-JAZZ-2016-US-012221 | JAZZ | 55.21 | YR | F | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125383771 | 12538377 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125383771 | 12538377 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125383771 | 12538377 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, FIRST DOSE | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 125383771 | 12538377 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, SECOND DOSE | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125383771 | 12538377 | 5 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125383771 | 12538377 | 6 | C | MODAFINIL. | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125383771 | 12538377 | 7 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125383771 | 12538377 | 8 | C | Atorvastatin | ATORVASTATIN | 1 | U | 0 | TABLET | ||||||||||
| 125383771 | 12538377 | 9 | C | BELSOMRA | SUVOREXANT | 1 | U | 0 | TABLET | ||||||||||
| 125383771 | 12538377 | 10 | C | GLIPIZIDE. | GLIPIZIDE | 1 | U | 0 | TABLET | ||||||||||
| 125383771 | 12538377 | 11 | C | Metformin Hcl | METFORMIN HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 125383771 | 12538377 | 12 | C | SILENOR | DOXEPIN HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 125383771 | 12538377 | 13 | C | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | U | 0 | TABLET | ||||||||||
| 125383771 | 12538377 | 14 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125383771 | 12538377 | 1 | Narcolepsy |
| 125383771 | 12538377 | 5 | Product used for unknown indication |
| 125383771 | 12538377 | 6 | Product used for unknown indication |
| 125383771 | 12538377 | 7 | Product used for unknown indication |
| 125383771 | 12538377 | 8 | Product used for unknown indication |
| 125383771 | 12538377 | 9 | Product used for unknown indication |
| 125383771 | 12538377 | 10 | Product used for unknown indication |
| 125383771 | 12538377 | 11 | Product used for unknown indication |
| 125383771 | 12538377 | 12 | Product used for unknown indication |
| 125383771 | 12538377 | 13 | Product used for unknown indication |
| 125383771 | 12538377 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125383771 | 12538377 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125383771 | 12538377 | Drug ineffective | |
| 125383771 | 12538377 | Feeling abnormal | |
| 125383771 | 12538377 | Hypertension | |
| 125383771 | 12538377 | Insomnia | |
| 125383771 | 12538377 | Type 2 diabetes mellitus |
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 |
|---|---|---|---|---|---|---|
| 125383771 | 12538377 | 1 | 201302 | 201302 | 0 | |
| 125383771 | 12538377 | 2 | 201302 | 201304 | 0 | |
| 125383771 | 12538377 | 3 | 201304 | 0 | ||
| 125383771 | 12538377 | 4 | 201304 | 0 | ||
| 125383771 | 12538377 | 6 | 20120601 | 0 | ||
| 125383771 | 12538377 | 7 | 20100101 | 0 |