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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126006641 | 12600664 | 1 | I | 201003 | 20100426 | 20160727 | 20160727 | EXP | FR-JAZZ-JPI-P-010614 | JAZZ | 80.47 | YR | M | Y | 105.00000 | KG | 20160727 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126006641 | 12600664 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1 G, BID | Y | 21196 | 1 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, SECOND DOSE | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, SECOND DOSE | Y | 21196 | 3.25 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, SECOND DOSE | Y | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 9 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 10 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.25 G, SECOND DOSE | Y | 21196 | 4.25 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 11 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 12 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 13 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | Y | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 126006641 | 12600664 | 14 | SS | KEPPRA | LEVETIRACETAM | 1 | 500 MG, BID | U | 0 | 500 | MG | ||||||||
| 126006641 | 12600664 | 15 | C | Cardensiel | BISOPROLOL FUMARATE | 1 | UNK | U | 0 | ||||||||||
| 126006641 | 12600664 | 16 | C | ASPEGIC | ASPIRIN DL-LYSINE | 1 | U | 0 | |||||||||||
| 126006641 | 12600664 | 17 | C | CORDARONE | AMIODARONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126006641 | 12600664 | 18 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 126006641 | 12600664 | 19 | C | RAMIPRIL. | RAMIPRIL | 1 | U | 0 | |||||||||||
| 126006641 | 12600664 | 20 | C | MODAFINIL. | MODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 126006641 | 12600664 | 21 | C | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 1 | 25 MG, BID | U | 0 | 25 | MG | ||||||||
| 126006641 | 12600664 | 22 | C | ESIDREX | HYDROCHLOROTHIAZIDE | 1 | 12.5 MG, QD | U | 0 | 12.5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126006641 | 12600664 | 1 | Narcolepsy |
| 126006641 | 12600664 | 2 | Cataplexy |
| 126006641 | 12600664 | 14 | Product used for unknown indication |
| 126006641 | 12600664 | 15 | Product used for unknown indication |
| 126006641 | 12600664 | 16 | Product used for unknown indication |
| 126006641 | 12600664 | 17 | Product used for unknown indication |
| 126006641 | 12600664 | 18 | Product used for unknown indication |
| 126006641 | 12600664 | 19 | Product used for unknown indication |
| 126006641 | 12600664 | 20 | Product used for unknown indication |
| 126006641 | 12600664 | 21 | Product used for unknown indication |
| 126006641 | 12600664 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126006641 | 12600664 | OT |
| 126006641 | 12600664 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126006641 | 12600664 | Chronic respiratory failure | |
| 126006641 | 12600664 | Fall | |
| 126006641 | 12600664 | Generalised tonic-clonic seizure | |
| 126006641 | 12600664 | Hypertensive crisis | |
| 126006641 | 12600664 | Ischaemic stroke | |
| 126006641 | 12600664 | Leukoencephalopathy | |
| 126006641 | 12600664 | Somnolence | |
| 126006641 | 12600664 | Status epilepticus |
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 |
|---|---|---|---|---|---|---|
| 126006641 | 12600664 | 1 | 20061218 | 20061220 | 0 | |
| 126006641 | 12600664 | 2 | 20061221 | 20070113 | 0 | |
| 126006641 | 12600664 | 3 | 20070119 | 20070127 | 0 | |
| 126006641 | 12600664 | 4 | 20070119 | 20070127 | 0 | |
| 126006641 | 12600664 | 5 | 20070128 | 20070205 | 0 | |
| 126006641 | 12600664 | 6 | 20070128 | 20070205 | 0 | |
| 126006641 | 12600664 | 7 | 20070206 | 20070208 | 0 | |
| 126006641 | 12600664 | 8 | 20070206 | 20070208 | 0 | |
| 126006641 | 12600664 | 9 | 20070209 | 20070213 | 0 | |
| 126006641 | 12600664 | 10 | 20070209 | 20070213 | 0 | |
| 126006641 | 12600664 | 11 | 20070214 | 20100315 | 0 | |
| 126006641 | 12600664 | 12 | 2016 | 0 | ||
| 126006641 | 12600664 | 13 | 20160530 | 0 | ||
| 126006641 | 12600664 | 14 | 20100315 | 0 |