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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 865484410 | 8654844 | 10 | F | 20120905 | 20160810 | 20120709 | 20160816 | EXP | US-GLAXOSMITHKLINE-A0983628A | GLAXOSMITHKLINE | 43.78 | YR | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 865484410 | 8654844 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | 35 NG/KG/MIN CONTINOUS45,000 NG/ML CONCENTRATIONVIAL STRENGTH 1.5 MG | U | M099 | 20444 | 35 | DF | POWDER FOR INFUSION | |||||
| 865484410 | 8654844 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | M197 | 20444 | POWDER FOR INFUSION | ||||||||
| 865484410 | 8654844 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | M240 | 20444 | POWDER FOR INFUSION | ||||||||
| 865484410 | 8654844 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N513 | 20444 | POWDER FOR INFUSION | ||||||||
| 865484410 | 8654844 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N644 | 20444 | POWDER FOR INFUSION | ||||||||
| 865484410 | 8654844 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P267 | 20444 | POWDER FOR INFUSION | ||||||||
| 865484410 | 8654844 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S276 | 20444 | POWDER FOR INFUSION | ||||||||
| 865484410 | 8654844 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 35.5 NG/KG/MIN | U | S925 | 20444 | POWDER FOR INFUSION | ||||||||
| 865484410 | 8654844 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | UNK UNK, CO | U | T662 | 20444 | POWDER FOR INFUSION | |||||||
| 865484410 | 8654844 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 35.5 NG/KG/MIN 45,000 NG/ML CONCENTRATION VIAL STRENGTH 1.5 MG, CO | U | Z606 | 20444 | 35.5 | DF | POWDER FOR INFUSION | ||||||
| 865484410 | 8654844 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | UNKNOWN | 0 | SOLUTION FOR INJECTION | ||||||||
| 865484410 | 8654844 | 12 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 865484410 | 8654844 | 13 | C | LASIX | FUROSEMIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 865484410 | 8654844 | 1 | Cor pulmonale chronic |
| 865484410 | 8654844 | 2 | Pulmonary hypertension |
| 865484410 | 8654844 | 11 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 865484410 | 8654844 | HO |
| 865484410 | 8654844 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 865484410 | 8654844 | Adverse event | |
| 865484410 | 8654844 | Anal incontinence | |
| 865484410 | 8654844 | Asthma | |
| 865484410 | 8654844 | Chest discomfort | |
| 865484410 | 8654844 | Chest pain | |
| 865484410 | 8654844 | Device related infection | |
| 865484410 | 8654844 | Diarrhoea | |
| 865484410 | 8654844 | Dyspnoea | |
| 865484410 | 8654844 | Fatigue | |
| 865484410 | 8654844 | Flushing | |
| 865484410 | 8654844 | Headache | |
| 865484410 | 8654844 | Hyperhidrosis | |
| 865484410 | 8654844 | Lower respiratory tract infection | |
| 865484410 | 8654844 | Lower respiratory tract infection viral | |
| 865484410 | 8654844 | Productive cough | |
| 865484410 | 8654844 | Renal failure | |
| 865484410 | 8654844 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 865484410 | 8654844 | 1 | 20090130 | 0 | ||
| 865484410 | 8654844 | 2 | 20090130 | 0 | ||
| 865484410 | 8654844 | 3 | 20090130 | 0 | ||
| 865484410 | 8654844 | 4 | 20090130 | 0 | ||
| 865484410 | 8654844 | 5 | 20090130 | 0 | ||
| 865484410 | 8654844 | 6 | 20090130 | 0 | ||
| 865484410 | 8654844 | 7 | 20090130 | 0 | ||
| 865484410 | 8654844 | 9 | 20090130 | 0 | ||
| 865484410 | 8654844 | 10 | 20090302 | 0 |