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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118734113 | 11873411 | 3 | F | 20160809 | 20151228 | 20160819 | EXP | US-ACTELION-A-NJ2015-125877 | ACTELION | 5.00 | YR | C | M | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118734113 | 11873411 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | UNK | NP011A0101,HP015P0101,DP061P0112 | 21290 | TABLET | ||||||||
| 118734113 | 11873411 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 31.25 MG, UNK | NP014P0201 | 21290 | 31.25 | MG | TABLET | ||||||
| 118734113 | 11873411 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118734113 | 11873411 | 1 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118734113 | 11873411 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118734113 | 11873411 | Condition aggravated | |
| 118734113 | 11873411 | Ear infection | |
| 118734113 | 11873411 | Ear operation | |
| 118734113 | 11873411 | Lip operation | |
| 118734113 | 11873411 | Nasopharyngitis | |
| 118734113 | 11873411 | Pneumonia | |
| 118734113 | 11873411 | Viral upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 118734113 | 11873411 | 1 | 20130808 | 0 |