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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126673332 | 12667333 | 2 | F | 2016 | 20160826 | 20160819 | 20160902 | EXP | US-JAZZ-2016-US-015237 | JAZZ | 39.70 | YR | F | Y | 63.49000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126673332 | 12667333 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126673332 | 12667333 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 126673332 | 12667333 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, FIRST DOSE | Y | 21196 | 6 | G | ORAL SOLUTION | ||||||
| 126673332 | 12667333 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5 G, SECOND DOSE | Y | 21196 | 5 | G | ORAL SOLUTION | ||||||
| 126673332 | 12667333 | 5 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | UNK | Y | 0 | ||||||||||
| 126673332 | 12667333 | 6 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126673332 | 12667333 | 7 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126673332 | 12667333 | 8 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126673332 | 12667333 | 9 | C | LUNESTA | ESZOPICLONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126673332 | 12667333 | 10 | C | ORTHO-NOVUM 777 | ETHINYL ESTRADIOLNORETHINDRONE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126673332 | 12667333 | 1 | Narcolepsy |
| 126673332 | 12667333 | 5 | Seizure |
| 126673332 | 12667333 | 6 | Relaxation therapy |
| 126673332 | 12667333 | 7 | Product used for unknown indication |
| 126673332 | 12667333 | 8 | Relaxation therapy |
| 126673332 | 12667333 | 9 | Product used for unknown indication |
| 126673332 | 12667333 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126673332 | 12667333 | OT |
| 126673332 | 12667333 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126673332 | 12667333 | Concussion | |
| 126673332 | 12667333 | Fall | |
| 126673332 | 12667333 | Gastrointestinal disorder | |
| 126673332 | 12667333 | Headache | |
| 126673332 | 12667333 | Prescribed overdose | |
| 126673332 | 12667333 | Seizure | |
| 126673332 | 12667333 | Tongue injury |
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 |
|---|---|---|---|---|---|---|
| 126673332 | 12667333 | 1 | 201201 | 201202 | 0 | |
| 126673332 | 12667333 | 2 | 201202 | 0 | ||
| 126673332 | 12667333 | 3 | 2016 | 0 | ||
| 126673332 | 12667333 | 4 | 2016 | 0 | ||
| 126673332 | 12667333 | 5 | 2016 | 2016 | 0 | |
| 126673332 | 12667333 | 6 | 20151130 | 0 | ||
| 126673332 | 12667333 | 7 | 20151130 | 0 | ||
| 126673332 | 12667333 | 8 | 20150410 | 0 | ||
| 126673332 | 12667333 | 9 | 20010101 | 0 |