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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950191 | 12595019 | 1 | I | 201511 | 20151110 | 20160726 | 20160726 | EXP | US-UNITED THERAPEUTICS-UNT-2015-014366 | UNITED THERAPEUTICS | 47.09 | YR | F | Y | 124.72000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950191 | 12595019 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.02875 ?G/KG, CONTINUING | U | U | 2100703 | 21272 | INJECTION | ||||||
| 125950191 | 12595019 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.030625 ?G/KG,CONTINUING | U | U | 926117 | 21272 | INJECTION | ||||||
| 125950191 | 12595019 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.029375 ?G/KG,CONTINUING | U | U | 926117 | 21272 | INJECTION | ||||||
| 125950191 | 12595019 | 4 | SS | ADEMPAS | RIOCIGUAT | 1 | 1 MG, TID | 0 | 1 | MG | TID | ||||||||
| 125950191 | 12595019 | 5 | SS | DIGOXIN. | DIGOXIN | 1 | U | 0 | |||||||||||
| 125950191 | 12595019 | 6 | C | SILDENAFIL. | SILDENAFIL | 1 | U | U | 0 | ||||||||||
| 125950191 | 12595019 | 7 | C | OPSUMIT | MACITENTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125950191 | 12595019 | 1 | Pulmonary arterial hypertension |
| 125950191 | 12595019 | 4 | Product used for unknown indication |
| 125950191 | 12595019 | 5 | Product used for unknown indication |
| 125950191 | 12595019 | 6 | Product used for unknown indication |
| 125950191 | 12595019 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125950191 | 12595019 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125950191 | 12595019 | Abdominal discomfort | |
| 125950191 | 12595019 | Abdominal pain | |
| 125950191 | 12595019 | Bacterial infection | |
| 125950191 | 12595019 | Chest pain | |
| 125950191 | 12595019 | Condition aggravated | |
| 125950191 | 12595019 | Diarrhoea | |
| 125950191 | 12595019 | Dizziness | |
| 125950191 | 12595019 | Dyspnoea | |
| 125950191 | 12595019 | Fatigue | |
| 125950191 | 12595019 | Headache | |
| 125950191 | 12595019 | Hypoaesthesia | |
| 125950191 | 12595019 | Injection site pruritus | |
| 125950191 | 12595019 | Nausea | |
| 125950191 | 12595019 | Oedema peripheral | |
| 125950191 | 12595019 | Paraesthesia | |
| 125950191 | 12595019 | 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 |
|---|---|---|---|---|---|---|
| 125950191 | 12595019 | 1 | 20150413 | 0 |