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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125918641 | 12591864 | 1 | I | 20160204 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-001800 | UNITED THERAPEUTICS | 0.00 | M | Y | 91.61000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125918641 | 12591864 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.039 ?G/KG, CONTINUING | U | U | 2100666 | 21272 | .039 | UG/KG | INJECTION | ||||
| 125918641 | 12591864 | 2 | SS | TYVASO | TREPROSTINIL | 1 | 18-72 MICROGRAMS, QID | U | U | 2100716 | 0 | INHALATION GAS | QID | ||||||
| 125918641 | 12591864 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 3.875 MG, Q8H WITH FOOD | U | U | 2100397 | 0 | 3.875 | MG | TABLET | TID | |||
| 125918641 | 12591864 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 3.875 MG, TID | U | U | 2100684 | 0 | 3.875 | MG | TABLET | TID | |||
| 125918641 | 12591864 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | U | U | 2100397 | 0 | TABLET | |||||||
| 125918641 | 12591864 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | U | U | 2100398 | 0 | TABLET | |||||||
| 125918641 | 12591864 | 7 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | U | U | 2100679 | 0 | TABLET | |||||||
| 125918641 | 12591864 | 8 | C | TRACLEER | BOSENTAN | 1 | 0 | ||||||||||||
| 125918641 | 12591864 | 9 | C | REVATIO | SILDENAFIL CITRATE | 1 | 0 | ||||||||||||
| 125918641 | 12591864 | 10 | C | WARFARIN | WARFARIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125918641 | 12591864 | 1 | Pulmonary arterial hypertension |
| 125918641 | 12591864 | 2 | Product used for unknown indication |
| 125918641 | 12591864 | 3 | Pulmonary arterial hypertension |
| 125918641 | 12591864 | 8 | Product used for unknown indication |
| 125918641 | 12591864 | 9 | Product used for unknown indication |
| 125918641 | 12591864 | 10 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125918641 | 12591864 | Back pain | |
| 125918641 | 12591864 | Diarrhoea | |
| 125918641 | 12591864 | Disease progression | |
| 125918641 | 12591864 | Headache | |
| 125918641 | 12591864 | Hypotension | |
| 125918641 | 12591864 | Pain in extremity | |
| 125918641 | 12591864 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125918641 | 12591864 | 1 | 20160204 | 0 | ||
| 125918641 | 12591864 | 2 | 20110221 | 0 | ||
| 125918641 | 12591864 | 3 | 20150401 | 0 |