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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125065552 | 12506555 | 2 | F | 201605 | 20160718 | 20160628 | 20160726 | EXP | US-JAZZ-2016-US-011456 | JAZZ | 31.61 | YR | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125065552 | 12506555 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125065552 | 12506555 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSAGE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125065552 | 12506555 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNK UNK, BID | 21196 | ORAL SOLUTION | |||||||||
| 125065552 | 12506555 | 4 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065552 | 12506555 | 5 | C | Biotin | BIOTIN | 1 | U | 0 | TABLET | ||||||||||
| 125065552 | 12506555 | 6 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | TABLET | ||||||||||
| 125065552 | 12506555 | 7 | C | MODAFINIL. | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065552 | 12506555 | 8 | C | Multivitamin Daily | 2 | U | 0 | TABLET | |||||||||||
| 125065552 | 12506555 | 9 | C | Potassium citrate ER | 2 | U | 0 | TABLET | |||||||||||
| 125065552 | 12506555 | 10 | C | Probiotic | PROBIOTICS NOS | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125065552 | 12506555 | 1 | Narcolepsy |
| 125065552 | 12506555 | 4 | Product used for unknown indication |
| 125065552 | 12506555 | 5 | Product used for unknown indication |
| 125065552 | 12506555 | 6 | Product used for unknown indication |
| 125065552 | 12506555 | 7 | Product used for unknown indication |
| 125065552 | 12506555 | 8 | Product used for unknown indication |
| 125065552 | 12506555 | 9 | Product used for unknown indication |
| 125065552 | 12506555 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125065552 | 12506555 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125065552 | 12506555 | Decreased appetite | |
| 125065552 | 12506555 | Hangover | |
| 125065552 | 12506555 | Hypermetabolism | |
| 125065552 | 12506555 | Impaired gastric emptying | |
| 125065552 | 12506555 | Paranoia | |
| 125065552 | 12506555 | Pressure of speech | |
| 125065552 | 12506555 | Promiscuity | |
| 125065552 | 12506555 | Somnolence | |
| 125065552 | 12506555 | Unevaluable event | |
| 125065552 | 12506555 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125065552 | 12506555 | 1 | 201605 | 2016 | 0 | |
| 125065552 | 12506555 | 3 | 201606 | 0 | ||
| 125065552 | 12506555 | 4 | 201604 | 2016 | 0 | |
| 125065552 | 12506555 | 7 | 201604 | 0 |