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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127366142 | 12736614 | 2 | F | 201602 | 20160902 | 20160913 | 20160913 | PER | US-JNJFOC-20160703242 | JANSSEN | 46.83 | YR | A | M | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127366142 | 12736614 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Oral | THERAPY DURATION: 10 MONTHS | Y | N | 21692 | SUSTAINED RELEASE TABLETS | |||||||
| 127366142 | 12736614 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 4.5 | G | ORAL SOLUTION | BID | |||||||
| 127366142 | 12736614 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 3 | G | ORAL SOLUTION | BID | |||||||
| 127366142 | 12736614 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 4.5 | G | ORAL SOLUTION | BID | |||||||
| 127366142 | 12736614 | 5 | SS | XANAX | ALPRAZOLAM | 1 | Unknown | Y | 0 | TABLET | |||||||||
| 127366142 | 12736614 | 6 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | Y | 0 | TABLET | |||||||||
| 127366142 | 12736614 | 7 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | 0 | TABLET | ||||||||||
| 127366142 | 12736614 | 8 | C | LUNESTA | ESZOPICLONE | 1 | Unknown | 0 | TABLET | ||||||||||
| 127366142 | 12736614 | 9 | C | ABILIFY | ARIPIPRAZOLE | 1 | Unknown | 0 | TABLET | ||||||||||
| 127366142 | 12736614 | 10 | C | LYRICA | PREGABALIN | 1 | Unknown | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127366142 | 12736614 | 1 | Product used for unknown indication |
| 127366142 | 12736614 | 2 | Sleep disorder |
| 127366142 | 12736614 | 3 | Sleep disorder |
| 127366142 | 12736614 | 4 | Sleep disorder |
| 127366142 | 12736614 | 5 | Product used for unknown indication |
| 127366142 | 12736614 | 6 | Product used for unknown indication |
| 127366142 | 12736614 | 7 | Product used for unknown indication |
| 127366142 | 12736614 | 8 | Product used for unknown indication |
| 127366142 | 12736614 | 9 | Product used for unknown indication |
| 127366142 | 12736614 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127366142 | 12736614 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127366142 | 12736614 | Fall | |
| 127366142 | 12736614 | Seizure | |
| 127366142 | 12736614 | Upper limb fracture |
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 |
|---|---|---|---|---|---|---|
| 127366142 | 12736614 | 1 | 20150413 | 201602 | 0 | |
| 127366142 | 12736614 | 2 | 200601 | 2010 | 0 | |
| 127366142 | 12736614 | 3 | 200512 | 200601 | 0 | |
| 127366142 | 12736614 | 4 | 201507 | 0 | ||
| 127366142 | 12736614 | 5 | 20151002 | 201602 | 0 | |
| 127366142 | 12736614 | 6 | 20150413 | 201602 | 0 | |
| 127366142 | 12736614 | 7 | 201602 | 0 | ||
| 127366142 | 12736614 | 8 | 20151021 | 0 | ||
| 127366142 | 12736614 | 9 | 20150413 | 0 |