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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117430706 | 11743070 | 6 | F | 20160817 | 20151116 | 20160829 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-US2015-113393 | ACTELION | 75.00 | YR | E | F | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117430706 | 11743070 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP052P0101, IP053P0101,OP021P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 117430706 | 11743070 | 2 | C | REMODULIN | TREPROSTINIL | 1 | 93 NG/KG, PER MIN | 0 | /min | ||||||||||
| 117430706 | 11743070 | 3 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 117430706 | 11743070 | 4 | C | PROCARDIA | NIFEDIPINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117430706 | 11743070 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117430706 | 11743070 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117430706 | 11743070 | Abdominal discomfort | |
| 117430706 | 11743070 | Blood creatinine increased | |
| 117430706 | 11743070 | Decreased appetite | |
| 117430706 | 11743070 | Diarrhoea | |
| 117430706 | 11743070 | Dizziness | |
| 117430706 | 11743070 | Dyspnoea | |
| 117430706 | 11743070 | Fall | |
| 117430706 | 11743070 | Flushing | |
| 117430706 | 11743070 | Lethargy | |
| 117430706 | 11743070 | Nausea | |
| 117430706 | 11743070 | Pneumonia | |
| 117430706 | 11743070 | Pyrexia | |
| 117430706 | 11743070 | Urinary 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 |
|---|---|---|---|---|---|---|
| 117430706 | 11743070 | 1 | 20060207 | 0 |