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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945211 | 12594521 | 1 | I | 201512 | 20151218 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-016150 | UNITED THERAPEUTICS | 46.81 | YR | F | Y | 74.83000 | KG | 20160726 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945211 | 12594521 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.375 MG,TID | 2100397 | 203496 | .375 | MG | TABLET | TID | |||||
| 125945211 | 12594521 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1.25 MG, UNK | 203496 | 1.25 | MG | TABLET | |||||||
| 125945211 | 12594521 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.5 MG, TID | 2100398 | 203496 | .5 | MG | TABLET | TID | |||||
| 125945211 | 12594521 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | 2100684 | 203496 | TABLET | ||||||||
| 125945211 | 12594521 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1.25MG,TID | 203496 | 1.25 | MG | TABLET | TID | ||||||
| 125945211 | 12594521 | 6 | SS | TYVASO | TREPROSTINIL | 1 | 54 ?G, QID | 2100699 | 0 | 54 | UG | INHALATION GAS | QID | ||||||
| 125945211 | 12594521 | 7 | SS | TYVASO | TREPROSTINIL | 1 | UNK | 2100711 | 0 | INHALATION GAS | |||||||||
| 125945211 | 12594521 | 8 | SS | TYVASO | TREPROSTINIL | 1 | UNK | 0 | INHALATION GAS | ||||||||||
| 125945211 | 12594521 | 9 | SS | TYVASO | TREPROSTINIL | 1 | 18-54MICROGRAMS, QID | 2100715 | 0 | INHALATION GAS | QID | ||||||||
| 125945211 | 12594521 | 10 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | 1500225A | 0 | 10 | MG | TABLET | QD | |||||
| 125945211 | 12594521 | 11 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | SBFW | 0 | 10 | MG | TABLET | QD | |||||
| 125945211 | 12594521 | 12 | SS | LETAIRIS | AMBRISENTAN | 1 | 0 | TABLET | |||||||||||
| 125945211 | 12594521 | 13 | SS | OPSUMIT | MACITENTAN | 1 | Unknown | UNK | 0 | ||||||||||
| 125945211 | 12594521 | 14 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Oral | 20 MG, TID | 0 | 20 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125945211 | 12594521 | 1 | Pulmonary hypertension |
| 125945211 | 12594521 | 6 | Product used for unknown indication |
| 125945211 | 12594521 | 10 | Pulmonary hypertension |
| 125945211 | 12594521 | 11 | Right-to-left cardiac shunt |
| 125945211 | 12594521 | 12 | Cardiac failure |
| 125945211 | 12594521 | 13 | Product used for unknown indication |
| 125945211 | 12594521 | 14 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125945211 | 12594521 | Arthralgia | |
| 125945211 | 12594521 | Diarrhoea | |
| 125945211 | 12594521 | Headache | |
| 125945211 | 12594521 | Nausea | |
| 125945211 | 12594521 | Pain in jaw |
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 |
|---|---|---|---|---|---|---|
| 125945211 | 12594521 | 1 | 20151208 | 0 | ||
| 125945211 | 12594521 | 2 | 201512 | 0 | ||
| 125945211 | 12594521 | 5 | 20151209 | 0 | ||
| 125945211 | 12594521 | 6 | 20130905 | 0 | ||
| 125945211 | 12594521 | 8 | 2014 | 0 | ||
| 125945211 | 12594521 | 10 | 2014 | 0 | ||
| 125945211 | 12594521 | 11 | 20151208 | 0 | ||
| 125945211 | 12594521 | 13 | 20151223 | 0 | ||
| 125945211 | 12594521 | 14 | 2008 | 0 |