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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125948491 | 12594849 | 1 | I | 201512 | 20151228 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-016511 | UNITED THERAPEUTICS | 56.14 | YR | M | Y | 126.98000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125948491 | 12594849 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.375 MG, TID | Y | 2100397 | 203496 | .375 | MG | TABLET | TID | ||||
| 125948491 | 12594849 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.75 MG, TID | Y | 2100684 | 203496 | .75 | MG | TABLET | TID | ||||
| 125948491 | 12594849 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1.625 MG, TID | Y | 2100368 | 203496 | 1.625 | MG | TABLET | TID | ||||
| 125948491 | 12594849 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | Y | 2100397 | 203496 | TABLET | |||||||
| 125948491 | 12594849 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | Y | 2100398 | 203496 | TABLET | |||||||
| 125948491 | 12594849 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1.75 MG, TID | Y | 2100368 | 203496 | 1.75 | MG | TABLET | TID | ||||
| 125948491 | 12594849 | 7 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | Y | 2100397 | 203496 | TABLET | |||||||
| 125948491 | 12594849 | 8 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | Y | 2100368 | 203496 | TABLET | ||||||||
| 125948491 | 12594849 | 9 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2 MG, TID | Y | 2100370 | 203496 | 2 | MG | TABLET | TID | ||||
| 125948491 | 12594849 | 10 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1.875 MG, TID | Y | 2100684 | 203496 | 1.875 | MG | TABLET | TID | ||||
| 125948491 | 12594849 | 11 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | Y | 2100369 | 203496 | TABLET | |||||||
| 125948491 | 12594849 | 12 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | Y | 2100370 | 203496 | TABLET | |||||||
| 125948491 | 12594849 | 13 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | Y | 203496 | TABLET | |||||||||
| 125948491 | 12594849 | 14 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | Y | 203496 | TABLET | |||||||||
| 125948491 | 12594849 | 15 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | Y | 203496 | TABLET | |||||||||
| 125948491 | 12594849 | 16 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2.625 MG, TID | Y | 203496 | 2.625 | MG | TABLET | TID | |||||
| 125948491 | 12594849 | 17 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | Y | 203496 | TABLET | |||||||||
| 125948491 | 12594849 | 18 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 5 MG, QD | NZYD | 0 | 5 | MG | TABLET | QD | |||||
| 125948491 | 12594849 | 19 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | UNK | SBFS | 0 | TABLET | ||||||||
| 125948491 | 12594849 | 20 | SS | LETAIRIS | AMBRISENTAN | 1 | UNK | 0 | TABLET | ||||||||||
| 125948491 | 12594849 | 21 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125948491 | 12594849 | 1 | Pulmonary arterial hypertension |
| 125948491 | 12594849 | 18 | Product used for unknown indication |
| 125948491 | 12594849 | 21 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125948491 | 12594849 | Abdominal pain upper | |
| 125948491 | 12594849 | Arthralgia | |
| 125948491 | 12594849 | Diarrhoea | |
| 125948491 | 12594849 | Flatulence | |
| 125948491 | 12594849 | Insomnia | |
| 125948491 | 12594849 | Nausea | |
| 125948491 | 12594849 | Pain in extremity | |
| 125948491 | 12594849 | Vision blurred | |
| 125948491 | 12594849 | Vomiting | |
| 125948491 | 12594849 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125948491 | 12594849 | 1 | 20151216 | 0 | ||
| 125948491 | 12594849 | 2 | 20151216 | 0 | ||
| 125948491 | 12594849 | 18 | 20130813 | 0 |