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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119433822 | 11943382 | 2 | F | 2015 | 20160209 | 20160125 | 20160726 | EXP | US-UNITED THERAPEUTICS-UNT-2015-013646 | UNITED THERAPEUTICS | 58.59 | YR | F | Y | 92.47000 | KG | 20160726 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119433822 | 11943382 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.064 ?G/KG, CONTINUING | U | 2100665 | 21272 | .064 | UG/KG | INJECTION | |||||
| 119433822 | 11943382 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.054 ?G/KG, CONTINUING | U | 2100665 | 21272 | .054 | UG/KG | INJECTION | |||||
| 119433822 | 11943382 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | U | 2100666 | 21272 | INJECTION | ||||||||
| 119433822 | 11943382 | 4 | C | WARFARIN | WARFARIN | 1 | 0 | ||||||||||||
| 119433822 | 11943382 | 5 | C | LETAIRIS | AMBRISENTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119433822 | 11943382 | 1 | Pulmonary arterial hypertension |
| 119433822 | 11943382 | 4 | Product used for unknown indication |
| 119433822 | 11943382 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119433822 | 11943382 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119433822 | 11943382 | Dermatitis contact | |
| 119433822 | 11943382 | Dyspnoea | |
| 119433822 | 11943382 | Flushing | |
| 119433822 | 11943382 | Infusion site infection | |
| 119433822 | 11943382 | Infusion site injury | |
| 119433822 | 11943382 | Malabsorption from injection site | |
| 119433822 | 11943382 | Oedema |
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 |
|---|---|---|---|---|---|---|
| 119433822 | 11943382 | 1 | 20141120 | 201511 | 0 | |
| 119433822 | 11943382 | 2 | 20151111 | 0 |