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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126238561 | 12623856 | 1 | I | 2015 | 20160226 | 20160804 | 20160804 | PER | US-JAZZ-2016-US-003819 | JAZZ | 0.00 | F | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126238561 | 12623856 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126238561 | 12623856 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126238561 | 12623856 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 126238561 | 12623856 | 4 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | Y | U | 0 | TABLET | ||||||||
| 126238561 | 12623856 | 5 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Y | U | 0 | ||||||||||
| 126238561 | 12623856 | 6 | SS | PROVIGIL | MODAFINIL | 1 | Y | U | 0 | ||||||||||
| 126238561 | 12623856 | 7 | C | PATANOL | OLOPATADINE HYDROCHLORIDE | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 126238561 | 12623856 | 8 | C | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | ||||||||||
| 126238561 | 12623856 | 9 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 126238561 | 12623856 | 10 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | UNK | U | 0 | ||||||||||
| 126238561 | 12623856 | 11 | C | ACIDOPHILUS | LACTOBACILLUS ACIDOPHILUS | 1 | UNK | U | 0 | POWDER | |||||||||
| 126238561 | 12623856 | 12 | C | CRANBERRY. | CRANBERRY | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 13 | C | BACLOFEN. | BACLOFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 14 | C | BOTOX | ONABOTULINUMTOXINA | 1 | UNK | U | 0 | ||||||||||
| 126238561 | 12623856 | 15 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 16 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 17 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 18 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 19 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 20 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 21 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126238561 | 12623856 | 22 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 23 | C | BACLOFEN. | BACLOFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238561 | 12623856 | 24 | C | Ondansetron | ONDANSETRON | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126238561 | 12623856 | 1 | Narcolepsy |
| 126238561 | 12623856 | 2 | Cataplexy |
| 126238561 | 12623856 | 4 | Product used for unknown indication |
| 126238561 | 12623856 | 5 | Product used for unknown indication |
| 126238561 | 12623856 | 6 | Product used for unknown indication |
| 126238561 | 12623856 | 7 | Product used for unknown indication |
| 126238561 | 12623856 | 8 | Product used for unknown indication |
| 126238561 | 12623856 | 9 | Product used for unknown indication |
| 126238561 | 12623856 | 10 | Product used for unknown indication |
| 126238561 | 12623856 | 11 | Product used for unknown indication |
| 126238561 | 12623856 | 12 | Product used for unknown indication |
| 126238561 | 12623856 | 13 | Product used for unknown indication |
| 126238561 | 12623856 | 14 | Product used for unknown indication |
| 126238561 | 12623856 | 15 | Product used for unknown indication |
| 126238561 | 12623856 | 16 | Product used for unknown indication |
| 126238561 | 12623856 | 17 | Product used for unknown indication |
| 126238561 | 12623856 | 18 | Product used for unknown indication |
| 126238561 | 12623856 | 19 | Product used for unknown indication |
| 126238561 | 12623856 | 20 | Product used for unknown indication |
| 126238561 | 12623856 | 21 | Product used for unknown indication |
| 126238561 | 12623856 | 22 | Product used for unknown indication |
| 126238561 | 12623856 | 23 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126238561 | 12623856 | Alopecia | |
| 126238561 | 12623856 | Arthritis | |
| 126238561 | 12623856 | Dyspnoea | |
| 126238561 | 12623856 | Hypermobility syndrome | |
| 126238561 | 12623856 | Intervertebral disc disorder | |
| 126238561 | 12623856 | Musculoskeletal discomfort | |
| 126238561 | 12623856 | Musculoskeletal pain | |
| 126238561 | 12623856 | Pain | |
| 126238561 | 12623856 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 126238561 | 12623856 | 1 | 201511 | 201511 | 0 | |
| 126238561 | 12623856 | 2 | 201511 | 201511 | 0 | |
| 126238561 | 12623856 | 3 | 201511 | 0 | ||
| 126238561 | 12623856 | 4 | 20151109 | 20151116 | 0 | |
| 126238561 | 12623856 | 7 | 20160211 | 0 | ||
| 126238561 | 12623856 | 8 | 20160118 | 0 | ||
| 126238561 | 12623856 | 9 | 20160107 | 0 | ||
| 126238561 | 12623856 | 10 | 20151201 | 20160225 | 0 | |
| 126238561 | 12623856 | 11 | 20151116 | 20160225 | 0 | |
| 126238561 | 12623856 | 12 | 20151116 | 20160225 | 0 | |
| 126238561 | 12623856 | 13 | 20151109 | 20151111 | 0 | |
| 126238561 | 12623856 | 14 | 20151109 | 0 | ||
| 126238561 | 12623856 | 15 | 20151109 | 0 | ||
| 126238561 | 12623856 | 16 | 20151109 | 20151111 | 0 | |
| 126238561 | 12623856 | 17 | 20151109 | 0 | ||
| 126238561 | 12623856 | 18 | 20151109 | 0 | ||
| 126238561 | 12623856 | 19 | 20151109 | 0 | ||
| 126238561 | 12623856 | 20 | 20151109 | 0 | ||
| 126238561 | 12623856 | 21 | 20151109 | 0 | ||
| 126238561 | 12623856 | 22 | 20151109 | 0 |