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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93195497 | 9319549 | 7 | F | 20121008 | 20160919 | 20130530 | 20160923 | PER | US-GLAXOSMITHKLINE-A1002142A | GLAXOSMITHKLINE | 0.00 | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93195497 | 9319549 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | 42 NG/KG/MIN CONCENTRATION: 60,000 NG/ML PUMP RATE: 61 ML/DAY | U | M762 | 20444 | 43 | DF | POWDER FOR INFUSION | |||||
| 93195497 | 9319549 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R614 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195497 | 9319549 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S706 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195497 | 9319549 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | 42 NG/KG/MINCONCENTRATION: 60,000 NG/MLPUMP RATE: 61 ML/DAY | U | S967 | 20444 | 42 | DF | POWDER FOR INFUSION | |||||
| 93195497 | 9319549 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 41 DF, CO | U | U631 | 20444 | 41 | DF | POWDER FOR INFUSION | ||||||
| 93195497 | 9319549 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 41 NG/KG/MIN | U | W674 | 20444 | 41 | DF | POWDER FOR INFUSION | |||||
| 93195497 | 9319549 | 7 | SS | Flolan Diluent Solution for injection | GLYCINEMANNITOLSODIUM CHLORIDE | 1 | UNK | U | C764454 | 0 | SOLUTION FOR INJECTION | ||||||||
| 93195497 | 9319549 | 8 | C | Warfarin | WARFARIN | 1 | U | 0 | |||||||||||
| 93195497 | 9319549 | 9 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 93195497 | 9319549 | 10 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 93195497 | 9319549 | 11 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 93195497 | 9319549 | 12 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 0 | ||||||||||||
| 93195497 | 9319549 | 13 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 93195497 | 9319549 | 1 | Pulmonary arterial hypertension |
| 93195497 | 9319549 | 2 | Pulmonary arterial hypertension |
| 93195497 | 9319549 | 7 | Pulmonary arterial hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 93195497 | 9319549 | Catheter site pain | |
| 93195497 | 9319549 | Catheter site pruritus | |
| 93195497 | 9319549 | Nasopharyngitis | |
| 93195497 | 9319549 | Night sweats | |
| 93195497 | 9319549 | Pain | |
| 93195497 | 9319549 | Respiratory tract congestion |
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 |
|---|---|---|---|---|---|---|
| 93195497 | 9319549 | 1 | 19991002 | 0 | ||
| 93195497 | 9319549 | 2 | 19991002 | 0 | ||
| 93195497 | 9319549 | 3 | 19991002 | 0 | ||
| 93195497 | 9319549 | 4 | 19991002 | 0 | ||
| 93195497 | 9319549 | 6 | 20040706 | 0 | ||
| 93195497 | 9319549 | 7 | 20040706 | 0 |