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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931948017 | 9319480 | 17 | F | 20120810 | 20160913 | 20130530 | 20160919 | EXP | US-GLAXOSMITHKLINE-A0989550A | GLAXOSMITHKLINE | 38.47 | YR | F | Y | 0.00000 | 20160919 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931948017 | 9319480 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 30 NG/KG/MIN CONTINUOUSLY, CONCENTRATION 30,000 NG/ML, VIAL STRENGTH 1.5 MGPUMP RATE: 76 ML/DAY[...] | U | M362 | 20444 | 30 | DF | POWDER FOR INFUSION | |||||
| 931948017 | 9319480 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | M461 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N145 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N388 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P669 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P828 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R058 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R529 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R614 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S706 | 20444 | POWDER FOR INFUSION | ||||||||
| 931948017 | 9319480 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 20 NG/KG/MIN | U | U631 | 20444 | 20 | DF | POWDER FOR INFUSION | ||||||
| 931948017 | 9319480 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29 NG/KG/MIN | U | U631 | 20444 | 29 | DF | POWDER FOR INFUSION | |||||
| 931948017 | 9319480 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29 NG/KG/MIN | U | U893 | 20444 | 29 | DF | POWDER FOR INFUSION | |||||
| 931948017 | 9319480 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29 NG/KG/MINUTE CONTINUOUSLY | U | V378 | 20444 | 29 | DF | POWDER FOR INFUSION | |||||
| 931948017 | 9319480 | 15 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29 NG/KG/MIN | U | V049 | 20444 | 29 | DF | POWDER FOR INFUSION | |||||
| 931948017 | 9319480 | 16 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29 NG/KG/MIN, CONTINUOUSLY | U | V934 | 20444 | 29 | DF | POWDER FOR INFUSION | |||||
| 931948017 | 9319480 | 17 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29 NG/KG/MIN, CONTINUOUSLY | U | Z606 | 20444 | 29 | DF | POWDER FOR INFUSION | |||||
| 931948017 | 9319480 | 18 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 29 NG/KG/MIN, CO | U | Z880 | 20444 | 29 | DF | POWDER FOR INFUSION | |||||
| 931948017 | 9319480 | 19 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 0 | SOLUTION FOR INJECTION | ||||||||||
| 931948017 | 9319480 | 20 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | C762536 | 0 | ||||||||||
| 931948017 | 9319480 | 21 | SS | OPSUMIT | MACITENTAN | 1 | U | 0 | |||||||||||
| 931948017 | 9319480 | 22 | SS | TRACLEER | BOSENTAN | 1 | D | 0 | |||||||||||
| 931948017 | 9319480 | 23 | C | ADCIRCA | TADALAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 931948017 | 9319480 | 1 | Pulmonary arterial hypertension |
| 931948017 | 9319480 | 19 | Pulmonary arterial hypertension |
| 931948017 | 9319480 | 21 | Product used for unknown indication |
| 931948017 | 9319480 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 931948017 | 9319480 | HO |
| 931948017 | 9319480 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 931948017 | 9319480 | Abdominal discomfort | |
| 931948017 | 9319480 | Asthenia | |
| 931948017 | 9319480 | Catheter site discharge | |
| 931948017 | 9319480 | Catheter site erythema | |
| 931948017 | 9319480 | Catheter site infection | |
| 931948017 | 9319480 | Catheter site pain | |
| 931948017 | 9319480 | Catheter site pruritus | |
| 931948017 | 9319480 | Central venous catheter removal | |
| 931948017 | 9319480 | Central venous catheterisation | |
| 931948017 | 9319480 | Complication associated with device | |
| 931948017 | 9319480 | Decreased appetite | |
| 931948017 | 9319480 | Device related infection | |
| 931948017 | 9319480 | Dyspnoea | |
| 931948017 | 9319480 | Emergency care examination | |
| 931948017 | 9319480 | Faeces discoloured | |
| 931948017 | 9319480 | Fatigue | |
| 931948017 | 9319480 | Feeling hot | |
| 931948017 | 9319480 | Gastrointestinal sounds abnormal | |
| 931948017 | 9319480 | Gingivitis | |
| 931948017 | 9319480 | Headache | |
| 931948017 | 9319480 | Heart rate increased | |
| 931948017 | 9319480 | Hyperhidrosis | |
| 931948017 | 9319480 | Infusion site erythema | |
| 931948017 | 9319480 | Infusion site swelling | |
| 931948017 | 9319480 | Infusion site warmth | |
| 931948017 | 9319480 | Malaise | |
| 931948017 | 9319480 | Nausea | |
| 931948017 | 9319480 | Oral candidiasis | |
| 931948017 | 9319480 | Pneumonitis | |
| 931948017 | 9319480 | Somnolence | |
| 931948017 | 9319480 | Staphylococcal skin infection | |
| 931948017 | 9319480 | Stress | |
| 931948017 | 9319480 | Ulcer | |
| 931948017 | 9319480 | Weight decreased | |
| 931948017 | 9319480 | Weight fluctuation |
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 |
|---|---|---|---|---|---|---|
| 931948017 | 9319480 | 1 | 20080728 | 0 | ||
| 931948017 | 9319480 | 2 | 20080729 | 0 | ||
| 931948017 | 9319480 | 3 | 20080729 | 0 | ||
| 931948017 | 9319480 | 4 | 20080729 | 0 | ||
| 931948017 | 9319480 | 5 | 20080729 | 0 | ||
| 931948017 | 9319480 | 6 | 20080729 | 0 | ||
| 931948017 | 9319480 | 7 | 20080729 | 0 | ||
| 931948017 | 9319480 | 8 | 20080729 | 0 | ||
| 931948017 | 9319480 | 9 | 20080729 | 0 | ||
| 931948017 | 9319480 | 10 | 20080728 | 0 | ||
| 931948017 | 9319480 | 16 | 20120703 | 0 | ||
| 931948017 | 9319480 | 17 | 20120703 | 0 |