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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121591094 | 12159109 | 4 | F | 201602 | 20160327 | 20160308 | 20160726 | EXP | US-UNITED THERAPEUTICS-UNT-2016-003299 | UNITED THERAPEUTICS | 77.34 | YR | F | Y | 61.68000 | KG | 20160726 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121591094 | 12159109 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.012 ?G/KG, CONTINUING | U | U | 926117 | 21272 | .012 | UG/KG | INJECTION | ||||
| 121591094 | 12159109 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.022 ?G/KG, CONTINUING | U | U | 926618 | 21272 | .022 | UG/KG | INJECTION | ||||
| 121591094 | 12159109 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.018 ?G/KG, CONTINUING | U | U | 926618 | 21272 | .018 | UG/KG | INJECTION | ||||
| 121591094 | 12159109 | 4 | C | REVATIO | SILDENAFIL CITRATE | 1 | 0 | ||||||||||||
| 121591094 | 12159109 | 5 | C | TRACLEER | BOSENTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121591094 | 12159109 | 1 | Pulmonary hypertension |
| 121591094 | 12159109 | 4 | Product used for unknown indication |
| 121591094 | 12159109 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121591094 | 12159109 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121591094 | 12159109 | Anxiety | |
| 121591094 | 12159109 | Asthenia | |
| 121591094 | 12159109 | Device infusion issue | |
| 121591094 | 12159109 | Device leakage | |
| 121591094 | 12159109 | Dizziness | |
| 121591094 | 12159109 | Drug dose omission | |
| 121591094 | 12159109 | Erythema | |
| 121591094 | 12159109 | Face oedema | |
| 121591094 | 12159109 | Headache | |
| 121591094 | 12159109 | Hypotension | |
| 121591094 | 12159109 | Hypoxia | |
| 121591094 | 12159109 | Infusion site erythema | |
| 121591094 | 12159109 | Infusion site reaction | |
| 121591094 | 12159109 | Nausea | |
| 121591094 | 12159109 | Oedema peripheral | |
| 121591094 | 12159109 | Overdose | |
| 121591094 | 12159109 | Therapy cessation | |
| 121591094 | 12159109 | 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 |
|---|---|---|---|---|---|---|
| 121591094 | 12159109 | 1 | 20151123 | 0 |