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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108720444 | 10872044 | 4 | F | 20140711 | 20160819 | 20150226 | 20160826 | EXP | US-JAZZ-2014-US-009109 | JAZZ | 61.40 | YR | M | Y | 117.91000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108720444 | 10872044 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | N | 3112102 | 21196 | 2.25 | G | ORAL SOLUTION | ||||
| 108720444 | 10872044 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | Y | N | 3117618 | 21196 | 3.75 | G | ORAL SOLUTION | ||||
| 108720444 | 10872044 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | N | 3118406 | 21196 | 4.5 | G | ORAL SOLUTION | ||||
| 108720444 | 10872044 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | Y | N | 21196 | ORAL SOLUTION | |||||||
| 108720444 | 10872044 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | Y | N | 21196 | 3.75 | G | ORAL SOLUTION | |||||
| 108720444 | 10872044 | 6 | SS | NUVIGIL | ARMODAFINIL | 1 | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108720444 | 10872044 | 1 | Narcolepsy |
| 108720444 | 10872044 | 2 | Cataplexy |
| 108720444 | 10872044 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108720444 | 10872044 | OT |
| 108720444 | 10872044 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108720444 | 10872044 | Blood test abnormal | |
| 108720444 | 10872044 | Condition aggravated | |
| 108720444 | 10872044 | Feeling abnormal | |
| 108720444 | 10872044 | Memory impairment | |
| 108720444 | 10872044 | 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 |
|---|---|---|---|---|---|---|
| 108720444 | 10872044 | 1 | 201403 | 2014 | 0 | |
| 108720444 | 10872044 | 2 | 201404 | 2014 | 0 | |
| 108720444 | 10872044 | 3 | 201406 | 20140712 | 0 | |
| 108720444 | 10872044 | 4 | 201411 | 201412 | 0 | |
| 108720444 | 10872044 | 5 | 2015 | 0 | ||
| 108720444 | 10872044 | 6 | 2014 | 0 |