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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238681 | 12523868 | 1 | I | 20151221 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022268 | JAZZ | 0.00 | F | Y | 0.00000 | 20160704 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238681 | 12523868 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125238681 | 12523868 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125238681 | 12523868 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, FIRST DOSE | 21196 | 3.25 | G | ORAL SOLUTION | |||||||
| 125238681 | 12523868 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, SECOND DOSE | 21196 | 3.25 | G | ORAL SOLUTION | |||||||
| 125238681 | 12523868 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, THIRD DOSE | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 125238681 | 12523868 | 6 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Oral | 25 MG, BID | U | 0 | 25 | MG | CAPSULE | ||||||
| 125238681 | 12523868 | 7 | C | LORATADINE. | LORATADINE | 1 | 10 MG, QD | U | 0 | 10 | MG | TABLET | |||||||
| 125238681 | 12523868 | 8 | C | Alprozolam | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238681 | 12523868 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 800 MG, QD | U | 0 | 800 | MG | TABLET | ||||||
| 125238681 | 12523868 | 10 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 125 ?G, QD | U | 0 | 125 | UG | TABLET | |||||||
| 125238681 | 12523868 | 11 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 125238681 | 12523868 | 12 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 125238681 | 12523868 | 13 | C | LEVOXYL | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 125238681 | 12523868 | 14 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238681 | 12523868 | 15 | C | SEROQUEL XR | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238681 | 12523868 | 16 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125238681 | 12523868 | 1 | Narcolepsy |
| 125238681 | 12523868 | 6 | Product used for unknown indication |
| 125238681 | 12523868 | 7 | Product used for unknown indication |
| 125238681 | 12523868 | 8 | Product used for unknown indication |
| 125238681 | 12523868 | 9 | Anxiety |
| 125238681 | 12523868 | 10 | Product used for unknown indication |
| 125238681 | 12523868 | 11 | Product used for unknown indication |
| 125238681 | 12523868 | 12 | Product used for unknown indication |
| 125238681 | 12523868 | 13 | Product used for unknown indication |
| 125238681 | 12523868 | 14 | Product used for unknown indication |
| 125238681 | 12523868 | 15 | Product used for unknown indication |
| 125238681 | 12523868 | 16 | Anxiety |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125238681 | 12523868 | Nausea | |
| 125238681 | 12523868 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125238681 | 12523868 | 1 | 200606 | 200607 | 0 | |
| 125238681 | 12523868 | 3 | 201404 | 0 | ||
| 125238681 | 12523868 | 4 | 201404 | 0 | ||
| 125238681 | 12523868 | 5 | 201404 | 0 | ||
| 125238681 | 12523868 | 6 | 20130628 | 0 |