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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126032482 | 12603248 | 2 | F | 20160715 | 20160728 | 20160728 | 20160810 | EXP | US-ACTELION-A-NJ2016-139849 | ACTELION | 67.00 | YR | E | M | Y | 0.00000 | 20160810 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126032482 | 12603248 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 21290 | 125 | MG | TABLET | BID | ||||||
| 126032482 | 12603248 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, TID | 21290 | 125 | MG | TABLET | TID | ||||||
| 126032482 | 12603248 | 3 | SS | RIOCIGUAT | RIOCIGUAT | 1 | Unknown | 2.5 MG, TID | Y | U | 0 | 2.5 | MG | TID | |||||
| 126032482 | 12603248 | 4 | C | TORSEMIDE. | TORSEMIDE | 1 | U | 0 | |||||||||||
| 126032482 | 12603248 | 5 | C | SOTALOL HCL | SOTALOL | 1 | U | 0 | |||||||||||
| 126032482 | 12603248 | 6 | C | DILTIAZEM. | DILTIAZEM | 1 | U | 0 | |||||||||||
| 126032482 | 12603248 | 7 | C | DIGOXIN. | DIGOXIN | 1 | U | 0 | |||||||||||
| 126032482 | 12603248 | 8 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 | |||||||||||
| 126032482 | 12603248 | 9 | C | SAW PALMETTO | SAW PALMETTO | 1 | U | 0 | |||||||||||
| 126032482 | 12603248 | 10 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 126032482 | 12603248 | 11 | C | METOPROLOL EG | 2 | U | 0 | ||||||||||||
| 126032482 | 12603248 | 12 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126032482 | 12603248 | 1 | Pulmonary arterial hypertension |
| 126032482 | 12603248 | 3 | Kidney infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126032482 | 12603248 | HO |
| 126032482 | 12603248 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126032482 | 12603248 | Acute kidney injury | |
| 126032482 | 12603248 | Asthenia | |
| 126032482 | 12603248 | Hypotension | |
| 126032482 | 12603248 | Oliguria | |
| 126032482 | 12603248 | Septic shock | |
| 126032482 | 12603248 | Streptococcal sepsis |
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 |
|---|---|---|---|---|---|---|
| 126032482 | 12603248 | 1 | 20120831 | 0 |