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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123566805 | 12356680 | 5 | F | 20160317 | 20160907 | 20160511 | 20160916 | EXP | US-UNITED THERAPEUTICS-UNT-2016-004971 | UNITED THERAPEUTICS | 75.09 | YR | F | Y | 56.00000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123566805 | 12356680 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.033 ?G/KG, CONTINUING | U | U | 2100580 | 21272 | .033 | UG/KG | INJECTION | ||||
| 123566805 | 12356680 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.048 ?G/KG, CONTINUING | U | U | 926619 | 21272 | .048 | UG/KG | INJECTION | ||||
| 123566805 | 12356680 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | UNK | U | U | 2100910 | 21272 | INJECTION | ||||||
| 123566805 | 12356680 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | U | U | 929006 | 21272 | INJECTION | |||||||
| 123566805 | 12356680 | 5 | SS | LETAIRIS | AMBRISENTAN | 1 | 5 MG, QD | Y | 1412805A | 0 | 5 | MG | QD | ||||||
| 123566805 | 12356680 | 6 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 | ||||||||||||
| 123566805 | 12356680 | 7 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123566805 | 12356680 | 1 | Pulmonary arterial hypertension |
| 123566805 | 12356680 | 5 | Product used for unknown indication |
| 123566805 | 12356680 | 6 | Product used for unknown indication |
| 123566805 | 12356680 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123566805 | 12356680 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123566805 | 12356680 | Blood pressure decreased | |
| 123566805 | 12356680 | Clostridium difficile infection | |
| 123566805 | 12356680 | Fluid overload | |
| 123566805 | 12356680 | Infusion site haemorrhage | |
| 123566805 | 12356680 | Infusion site pain | |
| 123566805 | 12356680 | Infusion site pruritus | |
| 123566805 | 12356680 | Pulmonary arterial hypertension |
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 |
|---|---|---|---|---|---|---|
| 123566805 | 12356680 | 1 | 20150904 | 0 | ||
| 123566805 | 12356680 | 5 | 201604 | 0 |