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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 858564411 | 8585644 | 11 | F | 20110901 | 20160824 | 20120530 | 20160826 | EXP | US-GLAXOSMITHKLINE-A0950342A | GLAXOSMITHKLINE | 47.78 | YR | F | Y | 85.00000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 858564411 | 8585644 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 13.5 NG/KG/MIN CONTINUOUSLY (CONCENTRATION 30,000 NG/ML; 1.5 MG VIAL STRENGTH)11.5 NG/KG/MIN, [...] | U | K640 | 20444 | 13.5 | DF | POWDER FOR INFUSION | |||||
| 858564411 | 8585644 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R271A | 20444 | POWDER FOR INFUSION | ||||||||
| 858564411 | 8585644 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R614 | 20444 | POWDER FOR INFUSION | ||||||||
| 858564411 | 8585644 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S925 | 20444 | POWDER FOR INFUSION | ||||||||
| 858564411 | 8585644 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 24 NG/KG/MIN | U | S925 | 20444 | POWDER FOR INFUSION | ||||||||
| 858564411 | 8585644 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 24 NG/KG/MIN, CO | U | T274 | 20444 | POWDER FOR INFUSION | ||||||||
| 858564411 | 8585644 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 85 DF, UNK | U | T274 | 20444 | 85 | DF | POWDER FOR INFUSION | |||||
| 858564411 | 8585644 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 24 DF, UNK | U | T794 | 20444 | 24 | DF | POWDER FOR INFUSION | |||||
| 858564411 | 8585644 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 24 NG/KG/MIN, CO | U | Z880 | 20444 | 24 | DF | POWDER FOR INFUSION | |||||
| 858564411 | 8585644 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | C764454 | 0 | SOLUTION FOR INJECTION | |||||||||
| 858564411 | 8585644 | 11 | C | LETAIRIS | AMBRISENTAN | 1 | Unknown | U | 0 | 5 | MG | QD | |||||||
| 858564411 | 8585644 | 12 | C | SILDENAFIL. | SILDENAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 858564411 | 8585644 | 1 | Cor pulmonale chronic |
| 858564411 | 8585644 | 2 | Systemic lupus erythematosus |
| 858564411 | 8585644 | 3 | Pulmonary hypertension |
| 858564411 | 8585644 | 10 | Pulmonary hypertension |
| 858564411 | 8585644 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 858564411 | 8585644 | HO |
| 858564411 | 8585644 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 858564411 | 8585644 | Arthritis | |
| 858564411 | 8585644 | Catheter site pruritus | |
| 858564411 | 8585644 | Central venous catheterisation | |
| 858564411 | 8585644 | Device issue | |
| 858564411 | 8585644 | Device related infection | |
| 858564411 | 8585644 | Diarrhoea | |
| 858564411 | 8585644 | Dyspnoea | |
| 858564411 | 8585644 | Fall | |
| 858564411 | 8585644 | Flushing | |
| 858564411 | 8585644 | Hospitalisation | |
| 858564411 | 8585644 | Hypotension | |
| 858564411 | 8585644 | Influenza like illness | |
| 858564411 | 8585644 | Localised infection | |
| 858564411 | 8585644 | Pneumonia | |
| 858564411 | 8585644 | Scratch | |
| 858564411 | 8585644 | Sepsis | |
| 858564411 | 8585644 | 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 |
|---|---|---|---|---|---|---|
| 858564411 | 8585644 | 1 | 20100912 | 0 |