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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109228925 | 10922892 | 5 | F | 20150730 | 20160620 | 20150317 | 20160701 | EXP | US-ACTELION-A-NJ2015-114444 | ACTELION | 38.00 | YR | A | M | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109228925 | 10922892 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | UNK | IP052P0101;IP053P0101,IP055P0101 | 21290 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109228925 | 10922892 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109228925 | 10922892 | HO |
| 109228925 | 10922892 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109228925 | 10922892 | Death | |
| 109228925 | 10922892 | Dizziness | |
| 109228925 | 10922892 | Finger amputation | |
| 109228925 | 10922892 | Poor peripheral circulation | |
| 109228925 | 10922892 | Renal failure | |
| 109228925 | 10922892 | Thrombosis | |
| 109228925 | 10922892 | Toxicity to various agents | |
| 109228925 | 10922892 | Unresponsive to stimuli |
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 |
|---|---|---|---|---|---|---|
| 109228925 | 10922892 | 1 | 20160328 | 0 |