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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122497845 | 12249784 | 5 | F | 20160306 | 20160812 | 20160408 | 20160825 | EXP | US-ACTELION-A-US2015-129011 | ACTELION | 42.00 | YR | A | F | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122497845 | 12249784 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 14.5 NG/KG, PER MIN | Y | MM073M0101,MM075M0101,MM076M0101 | 22260 | INJECTION | /min | ||||||
| 122497845 | 12249784 | 2 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 29.5 NG/KG, PER MIN | Y | MM081M0101, MM079M0101 | 22260 | INJECTION | /min | ||||||
| 122497845 | 12249784 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 40 MG, QD | Y | 0 | 40 | MG | QD | ||||||
| 122497845 | 12249784 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK MG, QD | Y | 0 | QD | ||||||||
| 122497845 | 12249784 | 5 | SS | ETHACRYNIC ACID. | ETHACRYNIC ACID | 1 | Unknown | 100 MG, QAM | U | U | 0 | 100 | MG | QD | |||||
| 122497845 | 12249784 | 6 | SS | ETHACRYNIC ACID. | ETHACRYNIC ACID | 1 | Unknown | 50 MG, QD | U | U | 0 | 50 | MG | QD | |||||
| 122497845 | 12249784 | 7 | SS | TORSEMIDE. | TORSEMIDE | 1 | Unknown | U | U | 0 | |||||||||
| 122497845 | 12249784 | 8 | C | SILDENAFIL. | SILDENAFIL | 1 | 20 MG, TID | U | 0 | 20 | MG | TID | |||||||
| 122497845 | 12249784 | 9 | C | WARFARIN | WARFARIN | 1 | UNK | U | 0 | ||||||||||
| 122497845 | 12249784 | 10 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 125 MCG, QD | U | 0 | 125 | UG | QD | ||||||
| 122497845 | 12249784 | 11 | C | URSODIOL. | URSODIOL | 1 | 300 MG, UNK | U | 0 | 300 | MG | BID | |||||||
| 122497845 | 12249784 | 12 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 25 MG, QD | U | 0 | 25 | MG | QD | |||||||
| 122497845 | 12249784 | 13 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 50 MG, QD | U | 0 | 50 | MG | QD | |||||||
| 122497845 | 12249784 | 14 | C | RISPERIDONE. | RISPERIDONE | 1 | 2 MG, QD | U | 0 | 2 | MG | QD | |||||||
| 122497845 | 12249784 | 15 | C | RISPERIDONE. | RISPERIDONE | 1 | Intramuscular | 12.5 MG, Q2WEEK | U | 0 | 12.5 | MG | QOW | ||||||
| 122497845 | 12249784 | 16 | C | GLIPIZIDE. | GLIPIZIDE | 1 | 15 MG, BID | U | 0 | 15 | MG | BID | |||||||
| 122497845 | 12249784 | 17 | C | MICROGESTIN | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | 1 TABLET, QD | U | 0 | QD | |||||||||
| 122497845 | 12249784 | 18 | C | BUMEX | BUMETANIDE | 1 | 2 MG, QD | U | 0 | 2 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122497845 | 12249784 | 1 | Pulmonary arterial hypertension |
| 122497845 | 12249784 | 3 | Drug reaction with eosinophilia and systemic symptoms |
| 122497845 | 12249784 | 5 | Product used for unknown indication |
| 122497845 | 12249784 | 7 | Product used for unknown indication |
| 122497845 | 12249784 | 8 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122497845 | 12249784 | OT |
| 122497845 | 12249784 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122497845 | 12249784 | Abdominal pain | |
| 122497845 | 12249784 | Acute respiratory distress syndrome | |
| 122497845 | 12249784 | Blood lactic acid increased | |
| 122497845 | 12249784 | Constipation | |
| 122497845 | 12249784 | Cough | |
| 122497845 | 12249784 | Dehydration | |
| 122497845 | 12249784 | Diarrhoea | |
| 122497845 | 12249784 | Drug reaction with eosinophilia and systemic symptoms | |
| 122497845 | 12249784 | Fluid overload | |
| 122497845 | 12249784 | Headache | |
| 122497845 | 12249784 | Hepatic congestion | |
| 122497845 | 12249784 | Immunosuppression | |
| 122497845 | 12249784 | Incorrect dose administered | |
| 122497845 | 12249784 | Lactic acidosis | |
| 122497845 | 12249784 | Nausea | |
| 122497845 | 12249784 | Pain in jaw | |
| 122497845 | 12249784 | Pneumonia | |
| 122497845 | 12249784 | Pulmonary arterial hypertension | |
| 122497845 | 12249784 | Pyrexia | |
| 122497845 | 12249784 | Rash generalised | |
| 122497845 | 12249784 | Right ventricular failure | |
| 122497845 | 12249784 | Sepsis | |
| 122497845 | 12249784 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 122497845 | 12249784 | 1 | 20151206 | 0 | ||
| 122497845 | 12249784 | 3 | 201604 | 0 | ||
| 122497845 | 12249784 | 5 | 20160216 | 0 | ||
| 122497845 | 12249784 | 6 | 20160216 | 0 | ||
| 122497845 | 12249784 | 9 | 20151214 | 20160311 | 0 | |
| 122497845 | 12249784 | 10 | 20151214 | 20160311 | 0 | |
| 122497845 | 12249784 | 12 | 20151214 | 20160319 | 0 | |
| 122497845 | 12249784 | 14 | 20140327 | 0 | ||
| 122497845 | 12249784 | 16 | 20160310 | 0 |