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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 907091331 | 9070913 | 31 | F | 20130114 | 20160919 | 20130129 | 20160921 | EXP | US-GLAXOSMITHKLINE-A1009064A | GLAXOSMITHKLINE | 36.45 | YR | F | Y | 58.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 907091331 | 9070913 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 119 NG/KG/MIN, CONCETRATION: 135,000 NG/ML, VIAL STRENGTH: 1.5 MG126 NG/KG/MIN 129 NG/KG/MIN, C[...] | D | N145 | 20444 | 110 | DF | POWDER FOR INFUSION | |||||
| 907091331 | 9070913 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | P267 | 20444 | POWDER FOR INFUSION | ||||||||
| 907091331 | 9070913 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | P828 | 20444 | POWDER FOR INFUSION | ||||||||
| 907091331 | 9070913 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | R852 | 20444 | POWDER FOR INFUSION | ||||||||
| 907091331 | 9070913 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | S506 | 20444 | POWDER FOR INFUSION | ||||||||
| 907091331 | 9070913 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | R614 | 20444 | POWDER FOR INFUSION | ||||||||
| 907091331 | 9070913 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | S922 | 20444 | POWDER FOR INFUSION | ||||||||
| 907091331 | 9070913 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 154 NG/KG/MIN | D | U893 | 20444 | POWDER FOR INFUSION | |||||||
| 907091331 | 9070913 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 156 NG/KG/MIN CONTINUOUSLY | D | V378 | 20444 | 156 | DF | POWDER FOR INFUSION | ||||||
| 907091331 | 9070913 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 157 NG/KG/MIN | D | V380 | 20444 | 157 | DF | POWDER FOR INFUSION | |||||
| 907091331 | 9070913 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 159 DF, CO | D | V785 | 20444 | 159 | DF | POWDER FOR INFUSION | ||||||
| 907091331 | 9070913 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 161 NG/KG/MIN, CONTINUOUS | D | Z606 | 20444 | 161 | DF | POWDER FOR INFUSION | ||||||
| 907091331 | 9070913 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 164 NG/KG/MIN, CO | D | Z880 | 20444 | 164 | DF | POWDER FOR INFUSION | |||||
| 907091331 | 9070913 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | D | C760234 | 0 | SOLUTION FOR INJECTION | |||||||||
| 907091331 | 9070913 | 15 | C | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, 1D | U | 0 | 10 | MG | QD | ||||||
| 907091331 | 9070913 | 16 | C | COUMADIN | WARFARIN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 907091331 | 9070913 | 17 | C | REVATIO | SILDENAFIL CITRATE | 1 | Oral | 60 MG, TID | U | 0 | 60 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 907091331 | 9070913 | 1 | Pulmonary arterial hypertension |
| 907091331 | 9070913 | 14 | Pulmonary arterial hypertension |
| 907091331 | 9070913 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 907091331 | 9070913 | HO |
| 907091331 | 9070913 | OT |
| 907091331 | 9070913 | LT |
| 907091331 | 9070913 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 907091331 | 9070913 | Acute respiratory failure | |
| 907091331 | 9070913 | Cardiac failure congestive | |
| 907091331 | 9070913 | Catheter site extravasation | |
| 907091331 | 9070913 | Cellulitis | |
| 907091331 | 9070913 | Chest wall abscess | |
| 907091331 | 9070913 | Chronic kidney disease | |
| 907091331 | 9070913 | Complication associated with device | |
| 907091331 | 9070913 | Compression fracture | |
| 907091331 | 9070913 | Death | |
| 907091331 | 9070913 | Device related infection | |
| 907091331 | 9070913 | Drug dose omission | |
| 907091331 | 9070913 | Dyspnoea | |
| 907091331 | 9070913 | Emergency care | |
| 907091331 | 9070913 | Fluid retention | |
| 907091331 | 9070913 | Gout | |
| 907091331 | 9070913 | Heart rate increased | |
| 907091331 | 9070913 | Hospice care | |
| 907091331 | 9070913 | Hospitalisation | |
| 907091331 | 9070913 | Hypotension | |
| 907091331 | 9070913 | Infusion site infection | |
| 907091331 | 9070913 | Lung infection | |
| 907091331 | 9070913 | Nausea | |
| 907091331 | 9070913 | Osteoporosis | |
| 907091331 | 9070913 | Pneumonia | |
| 907091331 | 9070913 | Respiratory failure | |
| 907091331 | 9070913 | Resuscitation | |
| 907091331 | 9070913 | Right ventricular failure | |
| 907091331 | 9070913 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 907091331 | 9070913 | 1 | 20060621 | 0 | ||
| 907091331 | 9070913 | 2 | 20060621 | 0 | ||
| 907091331 | 9070913 | 3 | 20060621 | 0 | ||
| 907091331 | 9070913 | 4 | 20060621 | 0 | ||
| 907091331 | 9070913 | 5 | 20060621 | 0 | ||
| 907091331 | 9070913 | 6 | 20060621 | 0 | ||
| 907091331 | 9070913 | 7 | 20060621 | 0 | ||
| 907091331 | 9070913 | 11 | 20100611 | 0 | ||
| 907091331 | 9070913 | 12 | 20100611 | 0 |