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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931964113 | 9319641 | 13 | F | 20151031 | 20160906 | 20130530 | 20160912 | EXP | US-GLAXOSMITHKLINE-A1018095A | GLAXOSMITHKLINE | 38.09 | YR | F | Y | 66.00000 | KG | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931964113 | 9319641 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 5 NG/KG/MINUTE CONTINOUSLY12 NG/KG/MINUTE CONCENTRATION 15,000 NG/ML PUMP RATE 76 ML/DAY VIAL S[...] | U | N381 | 20444 | 3 | DF | POWDER FOR INFUSION | |||||
| 931964113 | 9319641 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P669 | 20444 | POWDER FOR INFUSION | ||||||||
| 931964113 | 9319641 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R271A | 20444 | POWDER FOR INFUSION | ||||||||
| 931964113 | 9319641 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | T794 | 20444 | POWDER FOR INFUSION | ||||||||
| 931964113 | 9319641 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 21 NG/KG/MIN | U | U631 | 20444 | POWDER FOR INFUSION | ||||||||
| 931964113 | 9319641 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 21 NG/KG/MIN CONTINUOUS | U | V049 | 20444 | 21 | DF | POWDER FOR INFUSION | ||||||
| 931964113 | 9319641 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 21.5 NG/KG/MIN CONTINUOUS | U | V049 | 20444 | 21.5 | DF | POWDER FOR INFUSION | |||||
| 931964113 | 9319641 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | V380 | 20444 | POWDER FOR INFUSION | ||||||||
| 931964113 | 9319641 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 24 NG/KG/MIN | U | Z606 | 20444 | POWDER FOR INFUSION | ||||||||
| 931964113 | 9319641 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 25 NG/KG/MIN, CO | U | Z880 | 20444 | 25 | DF | POWDER FOR INFUSION | |||||
| 931964113 | 9319641 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | C762536 | 0 | SOLUTION FOR INJECTION | |||||||||
| 931964113 | 9319641 | 12 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 931964113 | 9319641 | 13 | C | LETAIRIS | AMBRISENTAN | 1 | U | 0 | |||||||||||
| 931964113 | 9319641 | 14 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 931964113 | 9319641 | 15 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 931964113 | 9319641 | 16 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 0 | ||||||||||||
| 931964113 | 9319641 | 17 | C | WARFARIN | WARFARIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 931964113 | 9319641 | 1 | Cor pulmonale chronic |
| 931964113 | 9319641 | 2 | Pulmonary hypertension |
| 931964113 | 9319641 | 3 | Pulmonary hypertension |
| 931964113 | 9319641 | 11 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 931964113 | 9319641 | OT |
| 931964113 | 9319641 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 931964113 | 9319641 | Application site papules | |
| 931964113 | 9319641 | Back pain | |
| 931964113 | 9319641 | Catheter site discharge | |
| 931964113 | 9319641 | Catheter site discolouration | |
| 931964113 | 9319641 | Catheter site erythema | |
| 931964113 | 9319641 | Catheter site haemorrhage | |
| 931964113 | 9319641 | Catheter site infection | |
| 931964113 | 9319641 | Catheter site mass | |
| 931964113 | 9319641 | Catheter site scab | |
| 931964113 | 9319641 | Central venous catheter removal | |
| 931964113 | 9319641 | Central venous catheterisation | |
| 931964113 | 9319641 | Dermatitis contact | |
| 931964113 | 9319641 | Drug hypersensitivity | |
| 931964113 | 9319641 | Dysphonia | |
| 931964113 | 9319641 | Haemorrhage | |
| 931964113 | 9319641 | Infusion site pain | |
| 931964113 | 9319641 | Infusion site pruritus | |
| 931964113 | 9319641 | Limb discomfort | |
| 931964113 | 9319641 | Meningitis viral | |
| 931964113 | 9319641 | Mobility decreased | |
| 931964113 | 9319641 | Muscle spasms | |
| 931964113 | 9319641 | Nasal congestion | |
| 931964113 | 9319641 | Nasal discharge discolouration | |
| 931964113 | 9319641 | Pain in extremity | |
| 931964113 | 9319641 | Paranasal sinus discomfort | |
| 931964113 | 9319641 | Peripheral swelling | |
| 931964113 | 9319641 | Skin irritation | |
| 931964113 | 9319641 | Sputum increased | |
| 931964113 | 9319641 | Swelling face | |
| 931964113 | 9319641 | Upper respiratory tract congestion | |
| 931964113 | 9319641 | Viral upper respiratory tract 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 |
|---|---|---|---|---|---|---|
| 931964113 | 9319641 | 1 | 20130308 | 0 | ||
| 931964113 | 9319641 | 2 | 20130308 | 0 | ||
| 931964113 | 9319641 | 3 | 20130308 | 0 | ||
| 931964113 | 9319641 | 4 | 20130308 | 0 | ||
| 931964113 | 9319641 | 8 | 20130313 | 0 |