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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125909552 | 12590955 | 2 | F | 20151124 | 20160201 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-015151 | UNITED THERAPEUTICS | 59.11 | YR | F | Y | 55.33000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125909552 | 12590955 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.014 ?G/KG, CONTINUING | U | U | 926117 | 21272 | .014 | UG/KG | INJECTION | ||||
| 125909552 | 12590955 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.017 ?G/KG CONTINUING | U | U | 926117 | 21272 | .017 | UG/KG | INJECTION | ||||
| 125909552 | 12590955 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.019 ?G/KG, CONTINUING | U | U | 926117 | 21272 | .019 | UG/KG | INJECTION | ||||
| 125909552 | 12590955 | 4 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | SBFT | 0 | 10 | MG | TABLET | QD | |||||
| 125909552 | 12590955 | 5 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 1500226A | 0 | 10 | MG | TABLET | QD | |||||
| 125909552 | 12590955 | 6 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125909552 | 12590955 | 1 | Pulmonary hypertension |
| 125909552 | 12590955 | 4 | Product used for unknown indication |
| 125909552 | 12590955 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125909552 | 12590955 | Confusional state | |
| 125909552 | 12590955 | Fatigue | |
| 125909552 | 12590955 | Headache | |
| 125909552 | 12590955 | Heart rate increased | |
| 125909552 | 12590955 | Musculoskeletal discomfort | |
| 125909552 | 12590955 | Musculoskeletal pain | |
| 125909552 | 12590955 | Nausea | |
| 125909552 | 12590955 | Oedema peripheral | |
| 125909552 | 12590955 | Pain in extremity | |
| 125909552 | 12590955 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125909552 | 12590955 | 1 | 20151124 | 0 | ||
| 125909552 | 12590955 | 3 | 20151124 | 0 | ||
| 125909552 | 12590955 | 4 | 20151125 | 0 |