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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 965319520 | 9653195 | 20 | F | 20131003 | 20160826 | 20131029 | 20160831 | EXP | US-GLAXOSMITHKLINE-A1047394A | GLAXOSMITHKLINE | 56.35 | YR | F | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 965319520 | 9653195 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 15 NG/KG/MIN CONTINUOUSLY (CONCENTRATION 15,000 NG/ML; 1.5 MG VIAL STRENGTH)16 NG/KG/MIN CONTIN[...] | U | P669 | 20444 | 15 | DF | POWDER FOR INFUSION | |||||
| 965319520 | 9653195 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R058 | 20444 | POWDER FOR INFUSION | ||||||||
| 965319520 | 9653195 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R529 | 20444 | POWDER FOR INFUSION | ||||||||
| 965319520 | 9653195 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R271A | 20444 | POWDER FOR INFUSION | ||||||||
| 965319520 | 9653195 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S506 | 20444 | POWDER FOR INFUSION | ||||||||
| 965319520 | 9653195 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 17 NG/KG/MIN, CONCENTRATION 15,000 NG/ML, PUMP RATE 82 ML/DAY, VIAL STRENGTH 1.5 MG, CO | U | T620 | 20444 | POWDER FOR INFUSION | |||||||
| 965319520 | 9653195 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 17NG/KG/MIN (CONCENTRATION 15,000 NG/ML, UNK PUMP RATE, VIAL STRENGTH 1.5 MG), CO | U | U052 | 20444 | POWDER FOR INFUSION | |||||||
| 965319520 | 9653195 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 17NG/KG/MIN (CONCENTRATION 15,000 NG/ML, UNK PUMP RATE, VIAL STRENGTH 1.5 MG), CO | U | V380 | 20444 | 17 | DF | POWDER FOR INFUSION | |||||
| 965319520 | 9653195 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | V926 | 20444 | POWDER FOR INFUSION | ||||||||
| 965319520 | 9653195 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | Z111 | 20444 | POWDER FOR INFUSION | ||||||||
| 965319520 | 9653195 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 17 NG/KG/MIN, CONTINUOUS | U | Z111 | 20444 | 17 | DF | POWDER FOR INFUSION | ||||||
| 965319520 | 9653195 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 17 DF, CO | U | Z606 | 20444 | 17 | DF | POWDER FOR INFUSION | ||||||
| 965319520 | 9653195 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 17 NG/KG/MIN, CO | U | Z880 | 20444 | 17 | DF | POWDER FOR INFUSION | |||||
| 965319520 | 9653195 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | C762537 | 0 | SOLUTION FOR INJECTION | |||||||||
| 965319520 | 9653195 | 15 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 0 | SOLUTION FOR INJECTION | ||||||||||
| 965319520 | 9653195 | 16 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 965319520 | 9653195 | 1 | Cor pulmonale chronic |
| 965319520 | 9653195 | 2 | Pulmonary hypertension |
| 965319520 | 9653195 | 14 | Pulmonary hypertension |
| 965319520 | 9653195 | 15 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 965319520 | 9653195 | HO |
| 965319520 | 9653195 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 965319520 | 9653195 | Anaemia | |
| 965319520 | 9653195 | Catheterisation cardiac | |
| 965319520 | 9653195 | Central venous catheterisation | |
| 965319520 | 9653195 | Device breakage | |
| 965319520 | 9653195 | Device infusion issue | |
| 965319520 | 9653195 | Device leakage | |
| 965319520 | 9653195 | Device related infection | |
| 965319520 | 9653195 | Diagnostic procedure | |
| 965319520 | 9653195 | Dyspnoea | |
| 965319520 | 9653195 | Feeling abnormal | |
| 965319520 | 9653195 | Hospitalisation | |
| 965319520 | 9653195 | Infusion site irritation | |
| 965319520 | 9653195 | Infusion site pain | |
| 965319520 | 9653195 | Malaise | |
| 965319520 | 9653195 | Neutropenia | |
| 965319520 | 9653195 | Oxygen saturation decreased | |
| 965319520 | 9653195 | Pancytopenia | |
| 965319520 | 9653195 | Platelet count decreased | |
| 965319520 | 9653195 | Pneumonia | |
| 965319520 | 9653195 | Pneumonia viral | |
| 965319520 | 9653195 | Pneumonitis | |
| 965319520 | 9653195 | Pulmonary arterial hypertension | |
| 965319520 | 9653195 | Pyrexia | |
| 965319520 | 9653195 | Thrombocytopenia | |
| 965319520 | 9653195 | Thrombosis in device | |
| 965319520 | 9653195 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 965319520 | 9653195 | 1 | 20101101 | 0 | ||
| 965319520 | 9653195 | 2 | 20101105 | 0 | ||
| 965319520 | 9653195 | 3 | 20101105 | 0 | ||
| 965319520 | 9653195 | 4 | 20101105 | 0 | ||
| 965319520 | 9653195 | 5 | 20101105 | 0 | ||
| 965319520 | 9653195 | 8 | 20130107 | 0 | ||
| 965319520 | 9653195 | 9 | 20130107 | 0 | ||
| 965319520 | 9653195 | 10 | 20130107 | 0 | ||
| 965319520 | 9653195 | 11 | 20130107 | 0 |