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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119225372 | 11922537 | 2 | F | 201403 | 20160801 | 20160115 | 20160809 | EXP | US-JAZZ-2014-US-002641 | JAZZ | 69.01 | YR | M | Y | 0.00000 | 20160809 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119225372 | 11922537 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 119225372 | 11922537 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 119225372 | 11922537 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 119225372 | 11922537 | 4 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 125 ?G, QD | U | 0 | 125 | UG | |||||||
| 119225372 | 11922537 | 5 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Oral | 25 MG, QD | U | 0 | 25 | MG | |||||||
| 119225372 | 11922537 | 6 | C | MODAFINIL. | MODAFINIL | 1 | Oral | 600 MG, QD | U | 0 | 600 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119225372 | 11922537 | 1 | Apnoea |
| 119225372 | 11922537 | 4 | Hypothyroidism |
| 119225372 | 11922537 | 5 | Oedema |
| 119225372 | 11922537 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119225372 | 11922537 | OT |
| 119225372 | 11922537 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119225372 | 11922537 | Atrioventricular block | |
| 119225372 | 11922537 | Chronic obstructive pulmonary disease | |
| 119225372 | 11922537 | Coronary artery disease | |
| 119225372 | 11922537 | Depression | |
| 119225372 | 11922537 | Dyspnoea | |
| 119225372 | 11922537 | Hyperlipidaemia | |
| 119225372 | 11922537 | Hypertension | |
| 119225372 | 11922537 | Peripheral swelling | |
| 119225372 | 11922537 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 119225372 | 11922537 | 1 | 200902 | 200903 | 0 | |
| 119225372 | 11922537 | 2 | 200903 | 201408 | 0 | |
| 119225372 | 11922537 | 3 | 201408 | 0 |