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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126351171 | 12635117 | 1 | I | 2007 | 20070309 | 20160808 | 20160808 | EXP | FR-JAZZ-JPI-P-000899 | JAZZ | 61.47 | YR | M | Y | 0.00000 | 20160808 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126351171 | 12635117 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 7844 | G | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 126351171 | 12635117 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 7844 | G | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 126351171 | 12635117 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, UNK | 7844 | G | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 126351171 | 12635117 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, QD | 7844 | G | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 126351171 | 12635117 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 7844 | G | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 126351171 | 12635117 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, QD | 7844 | G | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 126351171 | 12635117 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | UNK | 7844 | G | 21196 | ORAL SOLUTION | ||||||||
| 126351171 | 12635117 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, QD | 7844 | G | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 126351171 | 12635117 | 9 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | 400 | MG | |||||||||
| 126351171 | 12635117 | 10 | C | Clomipramine | CLOMIPRAMINE | 1 | U | 0 | 75 | MG | |||||||||
| 126351171 | 12635117 | 11 | C | Metformin embonate | 2 | U | 0 | ||||||||||||
| 126351171 | 12635117 | 12 | C | Trimetazidine hydrochloride | TRIMETAZIDINE DIHYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126351171 | 12635117 | 13 | C | FENOFIBRATE. | FENOFIBRATE | 1 | U | 0 | |||||||||||
| 126351171 | 12635117 | 14 | C | Ciprofibrate | CIPROFIBRATE | 1 | U | 0 | |||||||||||
| 126351171 | 12635117 | 15 | C | ESOMEPRAZOLE MAGNESIUM. | ESOMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 126351171 | 12635117 | 16 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126351171 | 12635117 | 1 | Narcolepsy |
| 126351171 | 12635117 | 2 | Cataplexy |
| 126351171 | 12635117 | 9 | Cataplexy |
| 126351171 | 12635117 | 10 | Depression |
| 126351171 | 12635117 | 11 | Type 2 diabetes mellitus |
| 126351171 | 12635117 | 12 | Product used for unknown indication |
| 126351171 | 12635117 | 13 | Product used for unknown indication |
| 126351171 | 12635117 | 14 | Dyslipidaemia |
| 126351171 | 12635117 | 15 | Abdominal pain upper |
| 126351171 | 12635117 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126351171 | 12635117 | OT |
| 126351171 | 12635117 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126351171 | 12635117 | Aggression | |
| 126351171 | 12635117 | Amnesia | |
| 126351171 | 12635117 | Disorientation | |
| 126351171 | 12635117 | Epilepsy | |
| 126351171 | 12635117 | Fall | |
| 126351171 | 12635117 | Hospitalisation | |
| 126351171 | 12635117 | Irritability | |
| 126351171 | 12635117 | Pleurisy | |
| 126351171 | 12635117 | Somnambulism | |
| 126351171 | 12635117 | Wound |
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 |
|---|---|---|---|---|---|---|
| 126351171 | 12635117 | 1 | 20061220 | 20070208 | 0 | |
| 126351171 | 12635117 | 2 | 20070209 | 20090603 | 0 | |
| 126351171 | 12635117 | 3 | 20090629 | 0 | ||
| 126351171 | 12635117 | 4 | 20120201 | 20120229 | 0 | |
| 126351171 | 12635117 | 5 | 20120301 | 20120305 | 0 | |
| 126351171 | 12635117 | 6 | 20120306 | 0 | ||
| 126351171 | 12635117 | 8 | 20160630 | 20160731 | 0 |