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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124974342 | 12497434 | 2 | F | 2014 | 20160712 | 20160624 | 20160720 | EXP | US-JAZZ-2016-US-010760 | JAZZ | 0.00 | F | Y | 0.00000 | 20160720 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124974342 | 12497434 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | N | U | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 124974342 | 12497434 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | N | U | 21196 | ORAL SOLUTION | |||||||
| 124974342 | 12497434 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | N | U | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 124974342 | 12497434 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, SECOND DOSE | N | U | 21196 | 3.25 | G | ORAL SOLUTION | |||||
| 124974342 | 12497434 | 5 | C | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974342 | 12497434 | 6 | C | DEPAKOTE ER | DIVALPROEX SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974342 | 12497434 | 7 | C | ELESTRIN | ESTRADIOL | 1 | UNK | U | 0 | GEL | |||||||||
| 124974342 | 12497434 | 8 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974342 | 12497434 | 9 | C | PROGESTERONE. | PROGESTERONE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124974342 | 12497434 | 10 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974342 | 12497434 | 11 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124974342 | 12497434 | 12 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124974342 | 12497434 | 1 | Narcolepsy |
| 124974342 | 12497434 | 2 | Somnolence |
| 124974342 | 12497434 | 5 | Product used for unknown indication |
| 124974342 | 12497434 | 6 | Product used for unknown indication |
| 124974342 | 12497434 | 7 | Product used for unknown indication |
| 124974342 | 12497434 | 8 | Product used for unknown indication |
| 124974342 | 12497434 | 9 | Product used for unknown indication |
| 124974342 | 12497434 | 10 | Product used for unknown indication |
| 124974342 | 12497434 | 11 | Product used for unknown indication |
| 124974342 | 12497434 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124974342 | 12497434 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124974342 | 12497434 | Confusional state | |
| 124974342 | 12497434 | Feeling abnormal | |
| 124974342 | 12497434 | Memory impairment | |
| 124974342 | 12497434 | Surgery |
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 |
|---|---|---|---|---|---|---|
| 124974342 | 12497434 | 1 | 201303 | 201304 | 0 | |
| 124974342 | 12497434 | 2 | 201304 | 201305 | 0 | |
| 124974342 | 12497434 | 3 | 201305 | 0 | ||
| 124974342 | 12497434 | 4 | 201305 | 0 | ||
| 124974342 | 12497434 | 5 | 20130212 | 20130326 | 0 | |
| 124974342 | 12497434 | 6 | 20110301 | 0 | ||
| 124974342 | 12497434 | 7 | 20110301 | 0 | ||
| 124974342 | 12497434 | 8 | 20110301 | 0 | ||
| 124974342 | 12497434 | 9 | 20110301 | 0 | ||
| 124974342 | 12497434 | 10 | 20110301 | 0 | ||
| 124974342 | 12497434 | 11 | 20090301 | 0 | ||
| 124974342 | 12497434 | 12 | 20000301 | 0 |