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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126776232 | 12677623 | 2 | F | 20160912 | 20160823 | 20160923 | EXP | US-ACTELION-A-NJ2016-138501 | ACTELION | 73.00 | YR | E | F | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126776232 | 12677623 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 126776232 | 12677623 | 2 | C | TYVASO | TREPROSTINIL | 1 | UNK | U | 0 | ||||||||||
| 126776232 | 12677623 | 3 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 126776232 | 12677623 | 4 | C | OXYGEN. | OXYGEN | 1 | U | 0 | |||||||||||
| 126776232 | 12677623 | 5 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 126776232 | 12677623 | 6 | C | IMURAN | AZATHIOPRINE | 1 | U | 0 | |||||||||||
| 126776232 | 12677623 | 7 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | U | 0 | |||||||||||
| 126776232 | 12677623 | 8 | C | METOPROLOL. | METOPROLOL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126776232 | 12677623 | 1 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126776232 | 12677623 | DE |
| 126776232 | 12677623 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126776232 | 12677623 | Condition aggravated | |
| 126776232 | 12677623 | Cyanosis | |
| 126776232 | 12677623 | Decreased appetite | |
| 126776232 | 12677623 | Diarrhoea | |
| 126776232 | 12677623 | Dizziness | |
| 126776232 | 12677623 | Gait disturbance | |
| 126776232 | 12677623 | Hypotension | |
| 126776232 | 12677623 | Interstitial lung disease | |
| 126776232 | 12677623 | Intestinal stenosis | |
| 126776232 | 12677623 | Leg amputation | |
| 126776232 | 12677623 | Peripheral arterial occlusive disease | |
| 126776232 | 12677623 | Peripheral swelling | |
| 126776232 | 12677623 | Peripheral vascular disorder | |
| 126776232 | 12677623 | Presyncope | |
| 126776232 | 12677623 | Respiratory failure | |
| 126776232 | 12677623 | Syncope | |
| 126776232 | 12677623 | Systemic scleroderma |
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 |
|---|---|---|---|---|---|---|
| 126776232 | 12677623 | 1 | 20031120 | 20160909 | 0 |