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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125858361 | 12585836 | 1 | I | 201003 | 20100426 | 20160725 | 20160725 | EXP | FR-UCBSA-010888 | UCB | 80.47 | YR | M | Y | 105.00000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125858361 | 12585836 | 1 | SS | Sodium oxybate | SODIUM OXYBATE | 1 | Oral | NIGHTLY | Y | 0 | 1 | G | ORAL SOLUTION | BID | |||||
| 125858361 | 12585836 | 2 | SS | Sodium oxybate | SODIUM OXYBATE | 1 | Oral | NIGHTLY | Y | 0 | 2.25 | G | ORAL SOLUTION | BID | |||||
| 125858361 | 12585836 | 3 | SS | Sodium oxybate | SODIUM OXYBATE | 1 | Oral | 4.50G+2.25G NIGHTLY | Y | 0 | ORAL SOLUTION | ||||||||
| 125858361 | 12585836 | 4 | SS | Sodium oxybate | SODIUM OXYBATE | 1 | Oral | 4.50G+3.25G NIGHTLY | Y | 0 | ORAL SOLUTION | ||||||||
| 125858361 | 12585836 | 5 | SS | Sodium oxybate | SODIUM OXYBATE | 1 | Oral | 4.50G+4G NIGHTLY | Y | 0 | ORAL SOLUTION | ||||||||
| 125858361 | 12585836 | 6 | SS | Sodium oxybate | SODIUM OXYBATE | 1 | Oral | 4.50G+4.25G NIGHTLY | Y | 0 | ORAL SOLUTION | ||||||||
| 125858361 | 12585836 | 7 | SS | Sodium oxybate | SODIUM OXYBATE | 1 | Oral | 4.5 G, 2X/DAY (BID) (NIGHTLY) | Y | 0 | 4.5 | G | ORAL SOLUTION | BID | |||||
| 125858361 | 12585836 | 8 | SS | Sodium oxybate | SODIUM OXYBATE | 1 | Oral | 4.5 G, 2X/DAY (BID) | Y | 0 | 4.5 | G | ORAL SOLUTION | BID | |||||
| 125858361 | 12585836 | 9 | PS | KEPPRA | LEVETIRACETAM | 1 | 500 MG, 2X/DAY (BID) | U | U | 21035 | 500 | MG | BID | ||||||
| 125858361 | 12585836 | 10 | C | Cardensiel | BISOPROLOL FUMARATE | 1 | U | U | 0 | ||||||||||
| 125858361 | 12585836 | 11 | C | ASPEGIC | ASPIRIN DL-LYSINE | 1 | U | U | 0 | ||||||||||
| 125858361 | 12585836 | 12 | C | CORDARONE | AMIODARONE HYDROCHLORIDE | 1 | U | U | 0 | ||||||||||
| 125858361 | 12585836 | 13 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | U | U | 0 | ||||||||||
| 125858361 | 12585836 | 14 | C | RAMIPRIL. | RAMIPRIL | 1 | U | U | 0 | ||||||||||
| 125858361 | 12585836 | 15 | C | Modiodal | MODAFINIL | 1 | U | U | 0 | ||||||||||
| 125858361 | 12585836 | 16 | C | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 1 | 25 MG, 2X/DAY (BID) | U | U | 0 | 25 | MG | BID | ||||||
| 125858361 | 12585836 | 17 | C | ESIDREX | HYDROCHLOROTHIAZIDE | 1 | 0.5 TABLET DAILY | U | U | 0 | 12.5 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125858361 | 12585836 | 1 | Narcolepsy |
| 125858361 | 12585836 | 2 | Cataplexy |
| 125858361 | 12585836 | 9 | Product used for unknown indication |
| 125858361 | 12585836 | 10 | Product used for unknown indication |
| 125858361 | 12585836 | 11 | Product used for unknown indication |
| 125858361 | 12585836 | 12 | Product used for unknown indication |
| 125858361 | 12585836 | 13 | Product used for unknown indication |
| 125858361 | 12585836 | 14 | Product used for unknown indication |
| 125858361 | 12585836 | 15 | Product used for unknown indication |
| 125858361 | 12585836 | 16 | Product used for unknown indication |
| 125858361 | 12585836 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125858361 | 12585836 | HO |
| 125858361 | 12585836 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125858361 | 12585836 | Cheyne-Stokes respiration | |
| 125858361 | 12585836 | Fall | |
| 125858361 | 12585836 | Generalised tonic-clonic seizure | |
| 125858361 | 12585836 | Hypertensive crisis | |
| 125858361 | 12585836 | Ischaemic stroke | |
| 125858361 | 12585836 | Somnolence | |
| 125858361 | 12585836 | 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 |
|---|---|---|---|---|---|---|
| 125858361 | 12585836 | 1 | 20061218 | 20061220 | 0 | |
| 125858361 | 12585836 | 2 | 20061221 | 20070113 | 0 | |
| 125858361 | 12585836 | 3 | 20070119 | 20070127 | 0 | |
| 125858361 | 12585836 | 4 | 20070128 | 20070205 | 0 | |
| 125858361 | 12585836 | 5 | 20070206 | 20070208 | 0 | |
| 125858361 | 12585836 | 6 | 20070209 | 20070213 | 0 | |
| 125858361 | 12585836 | 7 | 20070214 | 20100315 | 0 | |
| 125858361 | 12585836 | 8 | 2016 | 0 |