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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98080537 | 9808053 | 7 | F | 20140124 | 20160629 | 20140110 | 20160705 | EXP | US-GLAXOSMITHKLINE-A1055905A | GLAXOSMITHKLINE | 52.18 | YR | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98080537 | 9808053 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | DOSE: 22 NG/KG/MINCONCENTRATION: 30,000 NG/MLPUMP RATE: 84 ML/DAYVIAL STRENGTH: 1.5 MG | U | R271A | 20444 | 22 | DF | POWDER FOR INFUSION | |||||
| 98080537 | 9808053 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 22 NG/KG/MIN, CONTINUOUS | U | Z606 | 20444 | 22 | DF | POWDER FOR INFUSION | ||||||
| 98080537 | 9808053 | 3 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 98080537 | 9808053 | 4 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | U | 0 | |||||||||||
| 98080537 | 9808053 | 5 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98080537 | 9808053 | 1 | Cor pulmonale chronic |
| 98080537 | 9808053 | 2 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98080537 | 9808053 | OT |
| 98080537 | 9808053 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98080537 | 9808053 | Catheter removal | |
| 98080537 | 9808053 | Central venous catheterisation | |
| 98080537 | 9808053 | Cough | |
| 98080537 | 9808053 | Device dislocation | |
| 98080537 | 9808053 | Device issue | |
| 98080537 | 9808053 | Device related infection | |
| 98080537 | 9808053 | Dyspnoea | |
| 98080537 | 9808053 | Flushing | |
| 98080537 | 9808053 | Hospitalisation | |
| 98080537 | 9808053 | Infusion site infection | |
| 98080537 | 9808053 | Musculoskeletal pain | |
| 98080537 | 9808053 | Nausea | |
| 98080537 | 9808053 | Pain in extremity | |
| 98080537 | 9808053 | Pain in jaw | |
| 98080537 | 9808053 | Septic embolus | |
| 98080537 | 9808053 | Vein disorder |
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 |
|---|---|---|---|---|---|---|
| 98080537 | 9808053 | 1 | 20070906 | 0 |