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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144951 | 12714495 | 1 | I | 201605 | 20160511 | 20160905 | 20160905 | PER | US-JAZZ-2016-US-008887 | JAZZ | 46.39 | YR | F | Y | 74.83000 | KG | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144951 | 12714495 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127144951 | 12714495 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, FIRST DOSE | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 127144951 | 12714495 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, SECOND DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 127144951 | 12714495 | 4 | SS | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144951 | 12714495 | 5 | SS | NAPROXEN. | NAPROXEN | 1 | U | 0 | |||||||||||
| 127144951 | 12714495 | 6 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | TABLET | ||||||||||
| 127144951 | 12714495 | 7 | C | ALEVE | NAPROXEN SODIUM | 1 | U | 0 | |||||||||||
| 127144951 | 12714495 | 8 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | TABLET | ||||||||||
| 127144951 | 12714495 | 9 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144951 | 12714495 | 10 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 127144951 | 12714495 | 11 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144951 | 12714495 | 12 | C | TYLENOL | ACETAMINOPHEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127144951 | 12714495 | 1 | Narcolepsy |
| 127144951 | 12714495 | 4 | Product used for unknown indication |
| 127144951 | 12714495 | 5 | Product used for unknown indication |
| 127144951 | 12714495 | 6 | Narcolepsy |
| 127144951 | 12714495 | 7 | Product used for unknown indication |
| 127144951 | 12714495 | 8 | Product used for unknown indication |
| 127144951 | 12714495 | 9 | Narcolepsy |
| 127144951 | 12714495 | 10 | Hypothyroidism |
| 127144951 | 12714495 | 11 | Product used for unknown indication |
| 127144951 | 12714495 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127144951 | 12714495 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127144951 | 12714495 | Clavicle fracture | |
| 127144951 | 12714495 | Dizziness | |
| 127144951 | 12714495 | Fall | |
| 127144951 | 12714495 | Foot fracture | |
| 127144951 | 12714495 | Hypertension | |
| 127144951 | 12714495 | Ligament sprain | |
| 127144951 | 12714495 | Nausea | |
| 127144951 | 12714495 | Upper limb fracture | |
| 127144951 | 12714495 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127144951 | 12714495 | 1 | 201604 | 2016 | 0 | |
| 127144951 | 12714495 | 2 | 2016 | 0 | ||
| 127144951 | 12714495 | 3 | 2016 | 0 | ||
| 127144951 | 12714495 | 4 | 20160609 | 0 | ||
| 127144951 | 12714495 | 9 | 20160602 | 0 | ||
| 127144951 | 12714495 | 11 | 20160602 | 0 |