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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106649053 | 10664905 | 3 | F | 20141201 | 20160706 | 20141219 | 20160715 | EXP | JP-UNITED THERAPEUTICS-UNT-2014-012199 | UNITED THERAPEUTICS | 49.00 | YR | F | Y | 92.00000 | KG | 20160715 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106649053 | 10664905 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 9.5 MCL/H | Y | 21272 | INJECTION | ||||||||
| 106649053 | 10664905 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 15 MCL/H | Y | 21272 | INJECTION | ||||||||
| 106649053 | 10664905 | 3 | C | TRACLEER | BOSENTAN | 1 | Oral | 250 MG, UNK | 0 | 250 | MG | ||||||||
| 106649053 | 10664905 | 4 | C | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, UNK | 0 | 125 | MG | ||||||||
| 106649053 | 10664905 | 5 | C | PROCYLIN | BERAPROST SODIUM | 1 | Oral | 120 ?G, UNK | 0 | 120 | UG | ||||||||
| 106649053 | 10664905 | 6 | C | PROCYLIN | BERAPROST SODIUM | 1 | Oral | 40 ?G, UNK | 0 | 40 | UG | ||||||||
| 106649053 | 10664905 | 7 | C | ADCIRCA | TADALAFIL | 1 | 40 MG, UNK | 0 | 40 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106649053 | 10664905 | 1 | Pulmonary arterial hypertension |
| 106649053 | 10664905 | 2 | Pulmonary hypertension |
| 106649053 | 10664905 | 3 | Pulmonary hypertension |
| 106649053 | 10664905 | 5 | Pulmonary hypertension |
| 106649053 | 10664905 | 7 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106649053 | 10664905 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106649053 | 10664905 | Hypotension | |
| 106649053 | 10664905 | Infusion site erythema | |
| 106649053 | 10664905 | Infusion site induration | |
| 106649053 | 10664905 | Infusion site infection | |
| 106649053 | 10664905 | Infusion site oedema | |
| 106649053 | 10664905 | Infusion site pain | |
| 106649053 | 10664905 | Infusion site warmth | |
| 106649053 | 10664905 | Loss of consciousness | |
| 106649053 | 10664905 | Metrorrhagia | |
| 106649053 | 10664905 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 106649053 | 10664905 | 1 | 20141201 | 20141212 | 0 | |
| 106649053 | 10664905 | 5 | 201412 | 0 | ||
| 106649053 | 10664905 | 7 | 201412 | 0 |