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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123107295 | 12310729 | 5 | F | 20160416 | 20160902 | 20160427 | 20160914 | EXP | US-ACTELION-A-US2016-134992 | ACTELION | 77.00 | YR | E | M | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123107295 | 12310729 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, UNK | DP061P0112,OP023P0101 | 21290 | 62.5 | MG | TABLET | ||||||
| 123107295 | 12310729 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | 21290 | TABLET | |||||||||
| 123107295 | 12310729 | 3 | C | RIOCIGUAT | RIOCIGUAT | 1 | U | 0 | |||||||||||
| 123107295 | 12310729 | 4 | C | TYVASO | TREPROSTINIL | 1 | U | 0 | |||||||||||
| 123107295 | 12310729 | 5 | C | OXYGEN. | OXYGEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123107295 | 12310729 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123107295 | 12310729 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123107295 | 12310729 | Acute myocardial infarction | |
| 123107295 | 12310729 | Ascites | |
| 123107295 | 12310729 | Dyspnoea | |
| 123107295 | 12310729 | Hypotension | |
| 123107295 | 12310729 | Hypoxia | |
| 123107295 | 12310729 | Loss of consciousness | |
| 123107295 | 12310729 | Oxygen saturation decreased | |
| 123107295 | 12310729 | Pneumonia | |
| 123107295 | 12310729 | Pulmonary hypertension | |
| 123107295 | 12310729 | Right ventricular failure | |
| 123107295 | 12310729 | Syncope | |
| 123107295 | 12310729 | Troponin increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |