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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 937808611 | 9378086 | 11 | F | 20160906 | 20130701 | 20160908 | EXP | US-GLAXOSMITHKLINE-A1029005A | GLAXOSMITHKLINE | 0.00 | F | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 937808611 | 9378086 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 58 NG/KG/MIN CONTINUOUS;75000 NG/ML, NO PUMP RATE REPORTED, VIAL STRENGTH 1.5 MG | U | P057 | 20444 | POWDER FOR INFUSION | |||||||
| 937808611 | 9378086 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P508 | 20444 | POWDER FOR INFUSION | ||||||||
| 937808611 | 9378086 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 58 NG/KG/MIN CO; CONCENTRATION 75,000 NG/ML; PUMP RATE 78 ML/DAY; VIAL STRENGTH 1.5 MG | U | U383 | 20444 | POWDER FOR INFUSION | ||||||||
| 937808611 | 9378086 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 58 DF, CO | U | U893 | 20444 | 58 | DF | POWDER FOR INFUSION | ||||||
| 937808611 | 9378086 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 44 NG/KG/MIN CONTINUOUSLY | U | W674 | 20444 | 44 | DF | POWDER FOR INFUSION | ||||||
| 937808611 | 9378086 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 44 NG/KG/MIN CONTINUOUS | U | Z606 | 20444 | 44 | DF | POWDER FOR INFUSION | |||||
| 937808611 | 9378086 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 44 NG/KG/MIN, CO | U | Z880 | 20444 | 44 | DF | POWDER FOR INFUSION | |||||
| 937808611 | 9378086 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C762537 | 0 | SOLUTION FOR INJECTION | ||||||||
| 937808611 | 9378086 | 9 | SS | ADEMPAS | RIOCIGUAT | 1 | U | 0 | |||||||||||
| 937808611 | 9378086 | 10 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 937808611 | 9378086 | 11 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 937808611 | 9378086 | 1 | Cor pulmonale chronic |
| 937808611 | 9378086 | 2 | Pulmonary hypertension |
| 937808611 | 9378086 | 8 | Pulmonary hypertension |
| 937808611 | 9378086 | 9 | Product used for unknown indication |
| 937808611 | 9378086 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 937808611 | 9378086 | HO |
| 937808611 | 9378086 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 937808611 | 9378086 | Cough | |
| 937808611 | 9378086 | Fall | |
| 937808611 | 9378086 | Fluid retention | |
| 937808611 | 9378086 | Hand fracture | |
| 937808611 | 9378086 | Hepatic haemorrhage | |
| 937808611 | 9378086 | Hospitalisation | |
| 937808611 | 9378086 | Hypertension | |
| 937808611 | 9378086 | Infusion site extravasation | |
| 937808611 | 9378086 | Pneumonia | |
| 937808611 | 9378086 | Uterine leiomyoma embolisation | |
| 937808611 | 9378086 | Wrist fracture |
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 |
|---|---|---|---|---|---|---|
| 937808611 | 9378086 | 1 | 20090109 | 0 | ||
| 937808611 | 9378086 | 2 | 20090523 | 0 | ||
| 937808611 | 9378086 | 3 | 20090109 | 0 | ||
| 937808611 | 9378086 | 6 | 20090109 | 0 | ||
| 937808611 | 9378086 | 8 | 20160808 | 0 | ||
| 937808611 | 9378086 | 11 | 201605 | 0 |