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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1078153011 | 10781530 | 11 | F | 20160121 | 20160831 | 20150210 | 20160906 | EXP | US-GLAXOSMITHKLINE-A1070012A | GLAXOSMITHKLINE | 58.22 | YR | F | Y | 0.00000 | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1078153011 | 10781530 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29.3 NG/KG/MIN, 1.5 MG VIAL STRENGTH, 30,000 NG/ML CONCENTRATION | U | R614 | 20444 | 29.3 | DF | POWDER FOR INFUSION | |||||
| 1078153011 | 10781530 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29.32 NG/KG/MIN (CONCENTRATION 30,000 NG/ML, PUMP RATE 76 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | U631 | 20444 | POWDER FOR INFUSION | |||||||
| 1078153011 | 10781530 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 27.78 NG/KG/MIN, (CONCENTRATION 30,000 NG/ML, PUMP RATE 72 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | V378 | 20444 | 27.78 | DF | POWDER FOR INFUSION | ||||||
| 1078153011 | 10781530 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 26.2 DF, CO | U | V049 | 20444 | 26.2 | DF | POWDER FOR INFUSION | ||||||
| 1078153011 | 10781530 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 25.5 NG/KG/MIN | U | V785 | 20444 | POWDER FOR INFUSION | |||||||
| 1078153011 | 10781530 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | V785 | 20444 | POWDER FOR INFUSION | ||||||||
| 1078153011 | 10781530 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 25.5 NG/KG/MIN | U | V785 | 20444 | POWDER FOR INFUSION | |||||||
| 1078153011 | 10781530 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | Z606 | 20444 | POWDER FOR INFUSION | ||||||||
| 1078153011 | 10781530 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 23.53 NG/KG/MIN, CO | U | Z880 | 20444 | 23.53 | DF | POWDER FOR INFUSION | |||||
| 1078153011 | 10781530 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 0 | SOLUTION FOR INJECTION | ||||||||||
| 1078153011 | 10781530 | 11 | C | LIDOCAINE. | LIDOCAINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1078153011 | 10781530 | 1 | Cor pulmonale chronic |
| 1078153011 | 10781530 | 2 | Pulmonary hypertension |
| 1078153011 | 10781530 | 10 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1078153011 | 10781530 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1078153011 | 10781530 | Catheter site haemorrhage | |
| 1078153011 | 10781530 | Catheter site inflammation | |
| 1078153011 | 10781530 | Central venous catheterisation | |
| 1078153011 | 10781530 | Cough | |
| 1078153011 | 10781530 | Device breakage | |
| 1078153011 | 10781530 | Diarrhoea | |
| 1078153011 | 10781530 | Epistaxis | |
| 1078153011 | 10781530 | Flushing | |
| 1078153011 | 10781530 | Malabsorption | |
| 1078153011 | 10781530 | Nasopharyngitis | |
| 1078153011 | 10781530 | Night sweats | |
| 1078153011 | 10781530 | Pain in jaw | |
| 1078153011 | 10781530 | Paranasal sinus hypersecretion | |
| 1078153011 | 10781530 | Pyrexia | |
| 1078153011 | 10781530 | Respiratory tract congestion | |
| 1078153011 | 10781530 | Rhinorrhoea | |
| 1078153011 | 10781530 | Sinusitis | |
| 1078153011 | 10781530 | Throat irritation | |
| 1078153011 | 10781530 | Tooth fracture | |
| 1078153011 | 10781530 | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 1078153011 | 10781530 | 1 | 20140110 | 0 | ||
| 1078153011 | 10781530 | 6 | 20140110 | 0 | ||
| 1078153011 | 10781530 | 7 | 20140110 | 0 | ||
| 1078153011 | 10781530 | 8 | 20140110 | 0 |