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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116990232 | 11699023 | 2 | F | 201412 | 20160727 | 20151104 | 20160809 | EXP | US-ACTELION-A-US2015-126815 | ACTELION | 73.00 | YR | E | M | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116990232 | 11699023 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | ^FULL DOSE^, BID | 21290 | TABLET | BID | ||||||||
| 116990232 | 11699023 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | ^HALF A FULL DOSE^, BID | 21290 | TABLET | BID | ||||||||
| 116990232 | 11699023 | 3 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 40 MG, BID | 0 | 40 | MG | BID | |||||||
| 116990232 | 11699023 | 4 | C | SILDENAFIL. | SILDENAFIL | 1 | UNK, TID | U | 0 | TID | |||||||||
| 116990232 | 11699023 | 5 | C | COZAAR | LOSARTAN POTASSIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116990232 | 11699023 | 1 | Pulmonary arterial hypertension |
| 116990232 | 11699023 | 3 | Fluid retention |
| 116990232 | 11699023 | 5 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116990232 | 11699023 | DS |
| 116990232 | 11699023 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116990232 | 11699023 | Blindness unilateral | |
| 116990232 | 11699023 | Cataract | |
| 116990232 | 11699023 | Cataract operation | |
| 116990232 | 11699023 | Drug dose omission | |
| 116990232 | 11699023 | Fluid retention | |
| 116990232 | 11699023 | Memory impairment | |
| 116990232 | 11699023 | Oedema peripheral | |
| 116990232 | 11699023 | Procedural complication | |
| 116990232 | 11699023 | Retinal detachment | |
| 116990232 | 11699023 | Retinopexy |
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 |
|---|---|---|---|---|---|---|
| 116990232 | 11699023 | 1 | 2006 | 0 | ||
| 116990232 | 11699023 | 2 | 2006 | 2006 | 0 | |
| 116990232 | 11699023 | 4 | 2006 | 0 |