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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93195405 | 9319540 | 5 | F | 20160219 | 20160729 | 20130530 | 20160804 | EXP | US-GLAXOSMITHKLINE-A1000155A | GLAXOSMITHKLINE | 56.61 | YR | M | Y | 85.00000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93195405 | 9319540 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 42 NG/KG/MIN CONTINUOUS, 60,000 NG/ML, 89 ML/DAY, 1.5 MG | U | M762 | 20444 | 33 | DF | POWDER FOR INFUSION | |||||
| 93195405 | 9319540 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | M240 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195405 | 9319540 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S553 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195405 | 9319540 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 55 NG/KG/MIN CONTINUOUSLY | U | V934 | 20444 | 55 | DF | POWDER FOR INFUSION | ||||||
| 93195405 | 9319540 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 56 NG/KG/MIN CONTINUOUSLY | U | 2880 | 20444 | 56 | DF | POWDER FOR INFUSION | ||||||
| 93195405 | 9319540 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 0 | SOLUTION FOR INJECTION | ||||||||||
| 93195405 | 9319540 | 7 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 93195405 | 9319540 | 8 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 93195405 | 9319540 | 1 | Cor pulmonale chronic |
| 93195405 | 9319540 | 2 | Pulmonary hypertension |
| 93195405 | 9319540 | 6 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 93195405 | 9319540 | HO |
| 93195405 | 9319540 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 93195405 | 9319540 | Bone pain | |
| 93195405 | 9319540 | Diabetes mellitus | |
| 93195405 | 9319540 | Pain in extremity | |
| 93195405 | 9319540 | Pain in jaw | |
| 93195405 | 9319540 | Pneumonia | |
| 93195405 | 9319540 | Rash | |
| 93195405 | 9319540 | Rash generalised | |
| 93195405 | 9319540 | Tooth extraction | |
| 93195405 | 9319540 | Tooth infection | |
| 93195405 | 9319540 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 93195405 | 9319540 | 1 | 20040816 | 0 | ||
| 93195405 | 9319540 | 2 | 20040816 | 0 | ||
| 93195405 | 9319540 | 3 | 20040816 | 0 | ||
| 93195405 | 9319540 | 4 | 20040812 | 0 | ||
| 93195405 | 9319540 | 5 | 20040812 | 0 |