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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92494828 | 9249482 | 8 | F | 20160713 | 20130423 | 20160725 | EXP | US-ACTELION-A-US2013-82151 | ACTELION | 59.00 | YR | A | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92494828 | 9249482 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | UNK UNK, | IP030P0101/IP033P0102/IP051P0101 | 21290 | TABLET | ||||||||
| 92494828 | 9249482 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 92494828 | 9249482 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 92494828 | 9249482 | 4 | C | NORVASC | AMLODIPINE BESYLATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 92494828 | 9249482 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 92494828 | 9249482 | OT |
| 92494828 | 9249482 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 92494828 | 9249482 | Anaemia | |
| 92494828 | 9249482 | Bladder disorder | |
| 92494828 | 9249482 | Blood urine present | |
| 92494828 | 9249482 | Breast cancer | |
| 92494828 | 9249482 | Breast operation | |
| 92494828 | 9249482 | Breast reconstruction | |
| 92494828 | 9249482 | Chest pain | |
| 92494828 | 9249482 | Cystitis interstitial | |
| 92494828 | 9249482 | Drug hypersensitivity | |
| 92494828 | 9249482 | Dyspnoea | |
| 92494828 | 9249482 | Dyspnoea exertional | |
| 92494828 | 9249482 | Fall | |
| 92494828 | 9249482 | Foot fracture | |
| 92494828 | 9249482 | Hypersensitivity | |
| 92494828 | 9249482 | Mastectomy | |
| 92494828 | 9249482 | Oedema | |
| 92494828 | 9249482 | Renal disorder | |
| 92494828 | 9249482 | Swelling face | |
| 92494828 | 9249482 | Syncope | |
| 92494828 | 9249482 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 92494828 | 9249482 | 1 | 20120116 | 0 |