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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93195818 | 9319581 | 8 | F | 20150330 | 20160825 | 20130530 | 20160830 | EXP | US-GLAXOSMITHKLINE-A1009056A | GLAXOSMITHKLINE | 66.12 | YR | F | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93195818 | 9319581 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | DOSE: 29.5 NG/KG/MIN, CONCENTRATION: 45,000 NG/ML, PUMP RATE: 66 ML/DAY, VIAL STRENGTH: 1.5 MG | U | N145 | 20444 | 29 | DF | POWDER FOR INFUSION | |||||
| 93195818 | 9319581 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S276 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195818 | 9319581 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 29.5 NG/KG/MIN 45,000 NG/ML 66 ML/DAY 1.5MG | U | T794 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195818 | 9319581 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 29.5 NG/KG/MIN | U | U052 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195818 | 9319581 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 29.5 NG/KG/MIN | U | T794 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195818 | 9319581 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 29.5 NG/KG/MIN, CO | U | Z880 | 20444 | 29.5 | DF | POWDER FOR INFUSION | ||||||
| 93195818 | 9319581 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | C760234 | 0 | SOLUTION FOR INJECTION | |||||||||
| 93195818 | 9319581 | 8 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 93195818 | 9319581 | 1 | Pulmonary arterial hypertension |
| 93195818 | 9319581 | 7 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 93195818 | 9319581 | HO |
| 93195818 | 9319581 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 93195818 | 9319581 | Contusion | |
| 93195818 | 9319581 | Device alarm issue | |
| 93195818 | 9319581 | Device infusion issue | |
| 93195818 | 9319581 | Drug dose omission | |
| 93195818 | 9319581 | Fall | |
| 93195818 | 9319581 | Herpes zoster | |
| 93195818 | 9319581 | Hypoacusis | |
| 93195818 | 9319581 | Nasopharyngitis | |
| 93195818 | 9319581 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 93195818 | 9319581 | 1 | 20050202 | 0 | ||
| 93195818 | 9319581 | 2 | 20050202 | 0 | ||
| 93195818 | 9319581 | 3 | 20050203 | 0 | ||
| 93195818 | 9319581 | 6 | 20050202 | 0 |