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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125794761 | 12579476 | 1 | I | 201605 | 20160713 | 20160721 | 20160721 | EXP | US-COVIS PHARMA S.A.R.L.-2016COV00058 | COVIS | 16.36 | YR | M | Y | 87.98000 | KG | 20160720 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125794761 | 12579476 | 1 | PS | LANOXIN | DIGOXIN | 1 | U | 9330 | |||||||||||
| 125794761 | 12579476 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 8 MG, 2X/DAY | N | 0 | 8 | MG | TABLET | BID | |||||
| 125794761 | 12579476 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | 0 | ||||||||||||
| 125794761 | 12579476 | 4 | C | LETAIRIS | AMBRISENTAN | 1 | 0 | ||||||||||||
| 125794761 | 12579476 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125794761 | 12579476 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125794761 | 12579476 | LT |
| 125794761 | 12579476 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125794761 | 12579476 | Endotracheal intubation | |
| 125794761 | 12579476 | Malaise | |
| 125794761 | 12579476 | Nausea | |
| 125794761 | 12579476 | Presyncope | |
| 125794761 | 12579476 | Pulmonary arterial hypertension | |
| 125794761 | 12579476 | Right ventricular failure | |
| 125794761 | 12579476 | 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 |
|---|---|---|---|---|---|---|
| 125794761 | 12579476 | 2 | 20141103 | 2016 | 0 |