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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126926163 | 12692616 | 3 | F | 20160805 | 20160909 | 20160829 | 20160920 | EXP | US-BAUSCH-BL-2016-020111 | BAUSCH AND LOMB | 19.21 | YR | F | Y | 47.62000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126926163 | 12692616 | 1 | PS | ATIVAN | LORAZEPAM | 1 | Unknown | U | 17794 | TABLET | |||||||||
| 126926163 | 12692616 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 40 | G | U | 0 | 4.5 | G | ORAL SOLUTION | BID | ||||
| 126926163 | 12692616 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 40 | G | U | 0 | 4.5 | G | ORAL SOLUTION | QD | ||||
| 126926163 | 12692616 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | FIRST DOSE | 40 | G | U | 0 | 4 | G | ORAL SOLUTION | ||||
| 126926163 | 12692616 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | SECOND DOSE | 40 | G | U | 0 | 2 | G | ORAL SOLUTION | ||||
| 126926163 | 12692616 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 40 | G | U | 0 | ORAL SOLUTION | |||||||
| 126926163 | 12692616 | 7 | C | BACLOFEN. | BACLOFEN | 1 | 0 | TABLET | |||||||||||
| 126926163 | 12692616 | 8 | C | DOXEPIN | DOXEPIN | 1 | Oral | 0 | |||||||||||
| 126926163 | 12692616 | 9 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126926163 | 12692616 | 1 | Product used for unknown indication |
| 126926163 | 12692616 | 2 | Narcolepsy |
| 126926163 | 12692616 | 3 | Cataplexy |
| 126926163 | 12692616 | 7 | Sleep disorder |
| 126926163 | 12692616 | 8 | Product used for unknown indication |
| 126926163 | 12692616 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126926163 | 12692616 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126926163 | 12692616 | Anxiety | |
| 126926163 | 12692616 | Apnoea | |
| 126926163 | 12692616 | Chest discomfort | |
| 126926163 | 12692616 | Chest pain | |
| 126926163 | 12692616 | Dizziness | |
| 126926163 | 12692616 | Dry skin | |
| 126926163 | 12692616 | Dyspnoea | |
| 126926163 | 12692616 | Fatigue | |
| 126926163 | 12692616 | Mood swings | |
| 126926163 | 12692616 | Panic attack | |
| 126926163 | 12692616 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 126926163 | 12692616 | 2 | 20160805 | 20160808 | 0 | |
| 126926163 | 12692616 | 3 | 20160809 | 20160809 | 0 | |
| 126926163 | 12692616 | 4 | 201608 | 0 | ||
| 126926163 | 12692616 | 5 | 201608 | 0 | ||
| 126926163 | 12692616 | 6 | 201608 | 0 | ||
| 126926163 | 12692616 | 7 | 20160629 | 0 | ||
| 126926163 | 12692616 | 8 | 20160629 | 0 | ||
| 126926163 | 12692616 | 9 | 20160211 | 0 |