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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 922567121 | 9225671 | 21 | F | 20130403 | 20160914 | 20130411 | 20160921 | EXP | US-GLAXOSMITHKLINE-A1019637A | GLAXOSMITHKLINE | 43.76 | YR | F | Y | 66.00000 | KG | 20160921 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 922567121 | 9225671 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | CONCENTRATION: 45,000 NG/MLVIAL STRENGTH: 1.5MG18 NG/KG/MIN AT A PUMP RATE OF 76 ML PER DAY | U | N513 | 20444 | 19 | DF | POWDER FOR INFUSION | |||||
| 922567121 | 9225671 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N848 | 20444 | POWDER FOR INFUSION | ||||||||
| 922567121 | 9225671 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P05705 | 20444 | POWDER FOR INFUSION | ||||||||
| 922567121 | 9225671 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S276 | 20444 | POWDER FOR INFUSION | ||||||||
| 922567121 | 9225671 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | T366 | 20444 | POWDER FOR INFUSION | ||||||||
| 922567121 | 9225671 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 18 NG/KG/MIN CONTINUOUS; CONCENTRATION: 45,000 NG/ML; PUMP RATE: 76 ML/DAY; VIAL STRENGTH: 1.5 MG | U | T366 | 20444 | POWDER FOR INFUSION | |||||||
| 922567121 | 9225671 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | 20444 | POWDER FOR INFUSION | |||||||||
| 922567121 | 9225671 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 22.5 NG/KG/MIN (CONCENTRATION 60000 NG/ML, PUMP RATE 71 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | U052 | 20444 | POWDER FOR INFUSION | |||||||
| 922567121 | 9225671 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 25 NG/KG/MIN | U | U893 | 20444 | 25 | DF | POWDER FOR INFUSION | ||||||
| 922567121 | 9225671 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 32.5 NG/KG/MIN | U | V785 | 20444 | 32.5 | DF | POWDER FOR INFUSION | ||||||
| 922567121 | 9225671 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 33 NG/KG/MIN CONTINUOUS | U | V785 | 20444 | 33 | DF | POWDER FOR INFUSION | |||||
| 922567121 | 9225671 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 33 DF, CO | U | Z111 | 20444 | 33 | DF | POWDER FOR INFUSION | ||||||
| 922567121 | 9225671 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 33 NG/KG/MIN CONTINUOUS; CONCENTRATION: 75,000 NG/ML; PUMP RATE: 84 ML/DAY; VIAL STRENGTH: 1.5 MG | U | Z606 | 20444 | POWDER FOR INFUSION | ||||||||
| 922567121 | 9225671 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 33 NG/KG/MIN CONTINUOUS; CONCENTRATION: 75,000 NG/ML; PUMP RATE: 84 ML/DAY; VIAL STRENGTH: 1.5 MG | U | Z880 | 20444 | POWDER FOR INFUSION | ||||||||
| 922567121 | 9225671 | 15 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 32 NG/KG/MIN | U | 20444 | POWDER FOR INFUSION | |||||||||
| 922567121 | 9225671 | 16 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C762537 | 0 | SOLUTION FOR INJECTION | ||||||||
| 922567121 | 9225671 | 17 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 764454 | 0 | SOLUTION FOR INJECTION | |||||||||
| 922567121 | 9225671 | 18 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C764454 | 0 | SOLUTION FOR INJECTION | ||||||||
| 922567121 | 9225671 | 19 | C | LETAIRIS | AMBRISENTAN | 1 | U | U | 0 | ||||||||||
| 922567121 | 9225671 | 20 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 922567121 | 9225671 | 21 | C | COUMADIN | WARFARIN SODIUM | 1 | U | U | 0 | ||||||||||
| 922567121 | 9225671 | 22 | C | SILDENAFIL CITRATE. | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 922567121 | 9225671 | 23 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 922567121 | 9225671 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 922567121 | 9225671 | OT |
| 922567121 | 9225671 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 922567121 | 9225671 | Bedridden | |
| 922567121 | 9225671 | Catheter site dryness | |
| 922567121 | 9225671 | Catheter site haemorrhage | |
| 922567121 | 9225671 | Catheter site pruritus | |
| 922567121 | 9225671 | Central venous catheter removal | |
| 922567121 | 9225671 | Central venous catheterisation | |
| 922567121 | 9225671 | Complication associated with device | |
| 922567121 | 9225671 | Continuous positive airway pressure | |
| 922567121 | 9225671 | Device leakage | |
| 922567121 | 9225671 | Device related infection | |
| 922567121 | 9225671 | Dry skin | |
| 922567121 | 9225671 | Dyspnoea | |
| 922567121 | 9225671 | Fluid retention | |
| 922567121 | 9225671 | Flushing | |
| 922567121 | 9225671 | Hospitalisation | |
| 922567121 | 9225671 | Lethargy | |
| 922567121 | 9225671 | Mental status changes | |
| 922567121 | 9225671 | Multiple sclerosis | |
| 922567121 | 9225671 | Nasopharyngitis | |
| 922567121 | 9225671 | Nausea | |
| 922567121 | 9225671 | Oxygen saturation decreased | |
| 922567121 | 9225671 | Pain in extremity | |
| 922567121 | 9225671 | Pneumonia | |
| 922567121 | 9225671 | Pruritus | |
| 922567121 | 9225671 | Pulmonary hypertension | |
| 922567121 | 9225671 | Skin ulcer | |
| 922567121 | 9225671 | Tachycardia | |
| 922567121 | 9225671 | Weight decreased | |
| 922567121 | 9225671 | 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 |
|---|---|---|---|---|---|---|
| 922567121 | 9225671 | 1 | 20070529 | 0 | ||
| 922567121 | 9225671 | 2 | 20070529 | 0 | ||
| 922567121 | 9225671 | 3 | 20070529 | 0 | ||
| 922567121 | 9225671 | 4 | 20070529 | 0 | ||
| 922567121 | 9225671 | 5 | 20070616 | 0 | ||
| 922567121 | 9225671 | 6 | 20070616 | 0 | ||
| 922567121 | 9225671 | 13 | 20100617 | 0 | ||
| 922567121 | 9225671 | 14 | 20100617 | 0 |