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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126201612 | 12620161 | 2 | F | 2014 | 20160808 | 20160803 | 20160816 | EXP | US-JAZZ-2016-US-014114 | JAZZ | 0.00 | F | Y | 0.00000 | 20160816 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126201612 | 12620161 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126201612 | 12620161 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 126201612 | 12620161 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | Y | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 126201612 | 12620161 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 126201612 | 12620161 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126201612 | 12620161 | 6 | SS | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126201612 | 12620161 | 7 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126201612 | 12620161 | 8 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126201612 | 12620161 | 9 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126201612 | 12620161 | 10 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126201612 | 12620161 | 11 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | U | 0 | CAPSULE | ||||||||||
| 126201612 | 12620161 | 12 | C | ZYPREXA | OLANZAPINE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126201612 | 12620161 | 1 | Narcolepsy |
| 126201612 | 12620161 | 6 | Product used for unknown indication |
| 126201612 | 12620161 | 7 | Product used for unknown indication |
| 126201612 | 12620161 | 8 | Product used for unknown indication |
| 126201612 | 12620161 | 9 | Product used for unknown indication |
| 126201612 | 12620161 | 10 | Product used for unknown indication |
| 126201612 | 12620161 | 11 | Product used for unknown indication |
| 126201612 | 12620161 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126201612 | 12620161 | OT |
| 126201612 | 12620161 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126201612 | 12620161 | Drug ineffective | |
| 126201612 | 12620161 | Suicidal ideation | |
| 126201612 | 12620161 | Victim of crime |
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 |
|---|---|---|---|---|---|---|
| 126201612 | 12620161 | 1 | 201305 | 201305 | 0 | |
| 126201612 | 12620161 | 2 | 201305 | 2014 | 0 | |
| 126201612 | 12620161 | 3 | 201604 | 201604 | 0 | |
| 126201612 | 12620161 | 4 | 201604 | 201606 | 0 | |
| 126201612 | 12620161 | 5 | 201606 | 0 | ||
| 126201612 | 12620161 | 6 | 201601 | 0 | ||
| 126201612 | 12620161 | 7 | 201607 | 0 | ||
| 126201612 | 12620161 | 8 | 20130523 | 201601 | 0 | |
| 126201612 | 12620161 | 9 | 20130101 | 0 | ||
| 126201612 | 12620161 | 10 | 20121001 | 201512 | 0 |