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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119435202 | 11943520 | 2 | F | 2015 | 20160404 | 20160125 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-012914 | UNITED THERAPEUTICS | 0.00 | M | Y | 21.77000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119435202 | 11943520 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.010 ?G/KG, CONTINUING | 2100431 | 21272 | .01 | UG/KG | INJECTION | ||||||
| 119435202 | 11943520 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.0086 ?G/KG, CONTINUING | 21272 | .008 | UG/KG | INJECTION | |||||||
| 119435202 | 11943520 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.022 ?G/KG, CONTINUING | 2100431 | 21272 | .022 | UG/KG | INJECTION | ||||||
| 119435202 | 11943520 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.013 ?G/KG, CONTINUING | 2100431 | 21272 | .013 | UG/KG | INJECTION | ||||||
| 119435202 | 11943520 | 5 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.014 ?G/KG, CONTINUING | 2100579 | 21272 | .014 | UG/KG | INJECTION | ||||||
| 119435202 | 11943520 | 6 | SS | TRACLEER | BOSENTAN | 1 | Unknown | 1.6 ML, BID | 0 | 1.6 | ML | BID | |||||||
| 119435202 | 11943520 | 7 | C | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119435202 | 11943520 | 1 | Pulmonary arterial hypertension |
| 119435202 | 11943520 | 2 | Pulmonary hypertension |
| 119435202 | 11943520 | 6 | Product used for unknown indication |
| 119435202 | 11943520 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119435202 | 11943520 | Alanine aminotransferase increased | |
| 119435202 | 11943520 | Aspartate aminotransferase increased | |
| 119435202 | 11943520 | Hypotension | |
| 119435202 | 11943520 | Immunodeficiency |
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 |
|---|---|---|---|---|---|---|
| 119435202 | 11943520 | 1 | 20151009 | 0 | ||
| 119435202 | 11943520 | 6 | 201510 | 0 |