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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124770683 | 12477068 | 3 | F | 2016 | 20160721 | 20160617 | 20160728 | EXP | US-JAZZ-2016-US-010806 | JAZZ | 0.00 | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124770683 | 12477068 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124770683 | 12477068 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124770683 | 12477068 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | SMALL DOSE OF XYREM | Y | 21196 | ORAL SOLUTION | ||||||||
| 124770683 | 12477068 | 4 | SS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Y | 0 | |||||||||||
| 124770683 | 12477068 | 5 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124770683 | 12477068 | 6 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 124770683 | 12477068 | 7 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 124770683 | 12477068 | 8 | C | BACLOFEN. | BACLOFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124770683 | 12477068 | 9 | C | CYTOMEL | LIOTHYRONINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124770683 | 12477068 | 10 | C | Diclofenac sodium er | DICLOFENAC SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124770683 | 12477068 | 11 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124770683 | 12477068 | 12 | C | MINOCYCLINE | MINOCYCLINEMINOCYCLINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124770683 | 12477068 | 13 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124770683 | 12477068 | 14 | C | PYRIDOSTIGMINE BROMIDE. | PYRIDOSTIGMINE BROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124770683 | 12477068 | 15 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 124770683 | 12477068 | 16 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124770683 | 12477068 | 17 | C | Indole-3-Carbinol | DIETARY SUPPLEMENT | 1 | UNK | U | 0 | POWDER | |||||||||
| 124770683 | 12477068 | 18 | C | Selenium dr | 2 | UNK | U | 0 | TABLET | ||||||||||
| 124770683 | 12477068 | 19 | C | Fish oil | FISH OIL | 1 | UNK | U | 0 | ||||||||||
| 124770683 | 12477068 | 20 | C | Acetyl l-carnitine | ACETYLCARNITINE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124770683 | 12477068 | 1 | Narcolepsy |
| 124770683 | 12477068 | 2 | Somnolence |
| 124770683 | 12477068 | 4 | Product used for unknown indication |
| 124770683 | 12477068 | 5 | Somnolence |
| 124770683 | 12477068 | 6 | Somnolence |
| 124770683 | 12477068 | 7 | Attention deficit/hyperactivity disorder |
| 124770683 | 12477068 | 8 | Product used for unknown indication |
| 124770683 | 12477068 | 9 | Product used for unknown indication |
| 124770683 | 12477068 | 10 | Product used for unknown indication |
| 124770683 | 12477068 | 11 | Product used for unknown indication |
| 124770683 | 12477068 | 12 | Product used for unknown indication |
| 124770683 | 12477068 | 13 | Product used for unknown indication |
| 124770683 | 12477068 | 14 | Product used for unknown indication |
| 124770683 | 12477068 | 15 | Product used for unknown indication |
| 124770683 | 12477068 | 16 | Product used for unknown indication |
| 124770683 | 12477068 | 17 | Product used for unknown indication |
| 124770683 | 12477068 | 18 | Product used for unknown indication |
| 124770683 | 12477068 | 19 | Product used for unknown indication |
| 124770683 | 12477068 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124770683 | 12477068 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124770683 | 12477068 | Abnormal behaviour | |
| 124770683 | 12477068 | Disorientation | |
| 124770683 | 12477068 | Euphoric mood | |
| 124770683 | 12477068 | Hallucination | |
| 124770683 | 12477068 | Insomnia | |
| 124770683 | 12477068 | Mania | |
| 124770683 | 12477068 | Psychotic disorder |
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 |
|---|---|---|---|---|---|---|
| 124770683 | 12477068 | 1 | 20160520 | 201605 | 0 | |
| 124770683 | 12477068 | 2 | 201605 | 201606 | 0 | |
| 124770683 | 12477068 | 3 | 201606 | 20160607 | 0 | |
| 124770683 | 12477068 | 5 | 20160506 | 0 | ||
| 124770683 | 12477068 | 8 | 20160506 | 20160522 | 0 | |
| 124770683 | 12477068 | 9 | 20160506 | 0 | ||
| 124770683 | 12477068 | 10 | 20160506 | 0 | ||
| 124770683 | 12477068 | 11 | 20160506 | 0 | ||
| 124770683 | 12477068 | 12 | 20160506 | 0 | ||
| 124770683 | 12477068 | 13 | 20160506 | 0 | ||
| 124770683 | 12477068 | 14 | 20160506 | 0 | ||
| 124770683 | 12477068 | 15 | 20160228 | 0 | ||
| 124770683 | 12477068 | 16 | 20150909 | 0 | ||
| 124770683 | 12477068 | 17 | 20150909 | 0 | ||
| 124770683 | 12477068 | 18 | 20150909 | 201605 | 0 | |
| 124770683 | 12477068 | 19 | 201406 | 0 | ||
| 124770683 | 12477068 | 20 | 200101 | 0 |