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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 878576220 | 8785762 | 20 | F | 201209 | 20160823 | 20120914 | 20160825 | EXP | US-GLAXOSMITHKLINE-A0992990A | GLAXOSMITHKLINE | 6.74 | YR | F | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 878576220 | 8785762 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | CONTINUOUS 18.5 NG/KG/MINCONCENTRATION 7500 NG/MLVIAL STRENGTH 1.5 MG20.5 NG/KG/MIN, CONC. 7,50[...] | U | M362 | 20444 | 18.5 | DF | POWDER FOR INFUSION | |||||
| 878576220 | 8785762 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | M461 | 20444 | POWDER FOR INFUSION | ||||||||
| 878576220 | 8785762 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | M938A | 20444 | POWDER FOR INFUSION | ||||||||
| 878576220 | 8785762 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N388 | 20444 | POWDER FOR INFUSION | ||||||||
| 878576220 | 8785762 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N644 | 20444 | POWDER FOR INFUSION | ||||||||
| 878576220 | 8785762 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P061 | 20444 | POWDER FOR INFUSION | ||||||||
| 878576220 | 8785762 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R058 | 20444 | POWDER FOR INFUSION | ||||||||
| 878576220 | 8785762 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S706 | 20444 | POWDER FOR INFUSION | ||||||||
| 878576220 | 8785762 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 19 DF, CO | U | Z606 | 20444 | 19 | DF | POWDER FOR INFUSION | ||||||
| 878576220 | 8785762 | 10 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 878576220 | 8785762 | 11 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 878576220 | 8785762 | 12 | C | TRACLEER | BOSENTAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 878576220 | 8785762 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 878576220 | 8785762 | OT |
| 878576220 | 8785762 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 878576220 | 8785762 | Application site swelling | |
| 878576220 | 8785762 | Arthralgia | |
| 878576220 | 8785762 | Asthma | |
| 878576220 | 8785762 | Catheter placement | |
| 878576220 | 8785762 | Complication associated with device | |
| 878576220 | 8785762 | Device leakage | |
| 878576220 | 8785762 | Influenza | |
| 878576220 | 8785762 | Myalgia | |
| 878576220 | 8785762 | Off label use | |
| 878576220 | 8785762 | Pallor | |
| 878576220 | 8785762 | Pharyngitis streptococcal | |
| 878576220 | 8785762 | Respiratory disorder | |
| 878576220 | 8785762 | Respiratory distress | |
| 878576220 | 8785762 | Scar | |
| 878576220 | 8785762 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 878576220 | 8785762 | 1 | 20070102 | 0 | ||
| 878576220 | 8785762 | 2 | 20070102 | 0 | ||
| 878576220 | 8785762 | 3 | 20070102 | 0 | ||
| 878576220 | 8785762 | 4 | 20070102 | 0 | ||
| 878576220 | 8785762 | 5 | 20070102 | 0 | ||
| 878576220 | 8785762 | 6 | 20070102 | 0 | ||
| 878576220 | 8785762 | 7 | 20070102 | 0 | ||
| 878576220 | 8785762 | 8 | 20070102 | 0 | ||
| 878576220 | 8785762 | 9 | 20070117 | 0 |