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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85668635 | 8566863 | 5 | F | 201205 | 20160830 | 20120517 | 20160909 | EXP | US-ACTELION-A-NJ2012-65418 | ACTELION | 82.00 | YR | E | M | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85668635 | 8566863 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 3250 | MG | N | 21290 | 125 | MG | TABLET | BID | |||
| 85668635 | 8566863 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | 3250 | MG | N | 21290 | 62.5 | MG | TABLET | BID | |||
| 85668635 | 8566863 | 3 | SS | TYVASO | TREPROSTINIL | 1 | Respiratory (inhalation) | 72 MCG, UNK | 0 | 72 | UG | ||||||||
| 85668635 | 8566863 | 4 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | 20 MG, UNK | N | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85668635 | 8566863 | 1 | Pulmonary arterial hypertension |
| 85668635 | 8566863 | 3 | Pulmonary arterial hypertension |
| 85668635 | 8566863 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85668635 | 8566863 | DE |
| 85668635 | 8566863 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85668635 | 8566863 | Anaemia | |
| 85668635 | 8566863 | Death | |
| 85668635 | 8566863 | Haematocrit decreased | |
| 85668635 | 8566863 | Haemoglobin decreased | |
| 85668635 | 8566863 | Red blood cell morphology abnormal |
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 |
|---|---|---|---|---|---|---|
| 85668635 | 8566863 | 1 | 20120413 | 0 | ||
| 85668635 | 8566863 | 2 | 20120317 | 20120412 | 0 | |
| 85668635 | 8566863 | 3 | 20110923 | 0 | ||
| 85668635 | 8566863 | 4 | 20121109 | 0 |