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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126048033 | 12604803 | 3 | F | 20160720 | 20160728 | 20160728 | 20160810 | PER | US-ACTELION-A-US2016-139803 | ACTELION | 62.00 | YR | A | M | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126048033 | 12604803 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 10 NG/KG, PER MIN | MM088M0101 | 22260 | INJECTION | /min | |||||||
| 126048033 | 12604803 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | U | U | 21290 | TABLET | ||||||||
| 126048033 | 12604803 | 3 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 126048033 | 12604803 | 4 | C | MIDODRINE | MIDODRINE | 1 | U | 0 | |||||||||||
| 126048033 | 12604803 | 5 | C | WARFARIN | WARFARIN | 1 | U | 0 | |||||||||||
| 126048033 | 12604803 | 6 | C | TACROLIMUS. | TACROLIMUS | 1 | U | 0 | |||||||||||
| 126048033 | 12604803 | 7 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126048033 | 12604803 | 8 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126048033 | 12604803 | 1 | Portopulmonary hypertension |
| 126048033 | 12604803 | 2 | Portopulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126048033 | 12604803 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126048033 | 12604803 | Blood culture positive | |
| 126048033 | 12604803 | Chills | |
| 126048033 | 12604803 | Cold sweat | |
| 126048033 | 12604803 | Device related infection | |
| 126048033 | 12604803 | Dialysis related complication | |
| 126048033 | 12604803 | Hypotension | |
| 126048033 | 12604803 | Oxygen saturation decreased | |
| 126048033 | 12604803 | Pyrexia | |
| 126048033 | 12604803 | Rash generalised | |
| 126048033 | 12604803 | Sepsis | |
| 126048033 | 12604803 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 126048033 | 12604803 | 1 | 20110317 | 0 |