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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126146601 | 12614660 | 1 | I | 20160217 | 20160802 | 20160802 | PER | US-JAZZ-2016-US-003026 | JAZZ | 0.00 | M | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126146601 | 12614660 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126146601 | 12614660 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126146601 | 12614660 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126146601 | 12614660 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126146601 | 12614660 | 5 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | N | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 6 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 7 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 8 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 9 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 10 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 11 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126146601 | 12614660 | 12 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 13 | C | EPIPEN | EPINEPHRINE | 1 | UNK | U | 0 | ||||||||||
| 126146601 | 12614660 | 14 | C | Ginkgo biloba | GINKGO | 1 | UNK | U | 0 | ||||||||||
| 126146601 | 12614660 | 15 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 16 | C | RANITIDINE. | RANITIDINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126146601 | 12614660 | 17 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146601 | 12614660 | 18 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126146601 | 12614660 | 1 | Narcolepsy |
| 126146601 | 12614660 | 5 | Product used for unknown indication |
| 126146601 | 12614660 | 6 | Product used for unknown indication |
| 126146601 | 12614660 | 7 | Product used for unknown indication |
| 126146601 | 12614660 | 9 | Product used for unknown indication |
| 126146601 | 12614660 | 10 | Product used for unknown indication |
| 126146601 | 12614660 | 11 | Product used for unknown indication |
| 126146601 | 12614660 | 12 | Product used for unknown indication |
| 126146601 | 12614660 | 13 | Product used for unknown indication |
| 126146601 | 12614660 | 14 | Product used for unknown indication |
| 126146601 | 12614660 | 15 | Product used for unknown indication |
| 126146601 | 12614660 | 16 | Product used for unknown indication |
| 126146601 | 12614660 | 17 | Product used for unknown indication |
| 126146601 | 12614660 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126146601 | 12614660 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126146601 | 12614660 | Feeling abnormal | |
| 126146601 | 12614660 | Sleep apnoea syndrome |
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 |
|---|---|---|---|---|---|---|
| 126146601 | 12614660 | 1 | 201204 | 2012 | 0 | |
| 126146601 | 12614660 | 3 | 2014 | 0 | ||
| 126146601 | 12614660 | 4 | 201403 | 0 | ||
| 126146601 | 12614660 | 5 | 20160217 | 0 | ||
| 126146601 | 12614660 | 6 | 20160117 | 0 | ||
| 126146601 | 12614660 | 7 | 20150327 | 0 | ||
| 126146601 | 12614660 | 9 | 20150327 | 0 | ||
| 126146601 | 12614660 | 10 | 20150327 | 0 | ||
| 126146601 | 12614660 | 11 | 20150122 | 0 | ||
| 126146601 | 12614660 | 15 | 20160217 | 0 |