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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125911621 | 12591162 | 1 | I | 201512 | 20151221 | 20160726 | 20160726 | EXP | US-UNITED THERAPEUTICS-UNT-2015-016265 | UNITED THERAPEUTICS | 19.70 | YR | M | Y | 56.24000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125911621 | 12591162 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 4.5 MG, TID | Y | U | 2100398 | 203496 | 4.5 | MG | TABLET | TID | |||
| 125911621 | 12591162 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | Y | U | 2100399 | 203496 | TABLET | ||||||
| 125911621 | 12591162 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5.625 MG, TID | Y | U | 2100684 | 203496 | 5.625 | MG | TABLET | TID | |||
| 125911621 | 12591162 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5.375 MG, TID | Y | U | 2100397 | 203496 | 5.375 | MG | TABLET | TID | |||
| 125911621 | 12591162 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5.875 MG, TID | Y | U | 2100397 | 203496 | 5.875 | MG | TABLET | TID | |||
| 125911621 | 12591162 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | Y | U | 2100679 | 203496 | TABLET | |||||||
| 125911621 | 12591162 | 7 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5.75 MG , TID | Y | U | 2100684 | 203496 | 5.75 | MG | TABLET | TID | |||
| 125911621 | 12591162 | 8 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5.5 MG, TID | Y | U | 2100684 | 203496 | 5.5 | MG | TABLET | TID | |||
| 125911621 | 12591162 | 9 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.125 MG, TID | Y | U | 203496 | .125 | MG | TABLET | TID | ||||
| 125911621 | 12591162 | 10 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5 MG, TID | Y | U | 203496 | 5 | MG | TABLET | TID | ||||
| 125911621 | 12591162 | 11 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.25 MG, TID | Y | U | 203496 | .25 | MG | TABLET | TID | ||||
| 125911621 | 12591162 | 12 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | SBFW | 0 | 10 | MG | TABLET | QD | |||||
| 125911621 | 12591162 | 13 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | UNK | 1500226A | 0 | TABLET | ||||||||
| 125911621 | 12591162 | 14 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | U | U | 0 | |||||||||
| 125911621 | 12591162 | 15 | SS | WARFARIN | WARFARIN | 1 | Oral | 1 MG, QD | U | U | 0 | 1 | MG | TABLET | QD | ||||
| 125911621 | 12591162 | 16 | SS | WARFARIN | WARFARIN | 1 | Oral | 5 MG, QD | U | U | 0 | 5 | MG | TABLET | QD | ||||
| 125911621 | 12591162 | 17 | SS | WARFARIN | WARFARIN | 1 | Oral | 4 MG, QOD | U | U | 0 | 4 | MG | TABLET | QD | ||||
| 125911621 | 12591162 | 18 | SS | WARFARIN | WARFARIN | 1 | Oral | 1 MG, QOD | U | U | 0 | 1 | MG | TABLET | QD | ||||
| 125911621 | 12591162 | 19 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 20 | C | DELTASONE /00016001/ | 2 | 0 | |||||||||||||
| 125911621 | 12591162 | 21 | C | OCEAN NASAL | 2 | 0 | |||||||||||||
| 125911621 | 12591162 | 22 | C | ALDACTONE | SPIRONOLACTONE | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 23 | C | CIALIS | TADALAFIL | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 24 | C | OXYGEN. | OXYGEN | 1 | UNK | 0 | |||||||||||
| 125911621 | 12591162 | 25 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 26 | C | QVAR | BECLOMETHASONE DIPROPIONATE | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 27 | C | LANOXIN | DIGOXIN | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 28 | C | LOPRESSOR | METOPROLOL TARTRATE | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 29 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 30 | C | METOPROLOL. | METOPROLOL | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 31 | C | MARINOL /00003301/ | 2 | 0 | |||||||||||||
| 125911621 | 12591162 | 32 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 125911621 | 12591162 | 33 | C | SENNA /00571901/ | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125911621 | 12591162 | 1 | Pulmonary hypertension |
| 125911621 | 12591162 | 12 | Product used for unknown indication |
| 125911621 | 12591162 | 14 | Product used for unknown indication |
| 125911621 | 12591162 | 15 | Product used for unknown indication |
| 125911621 | 12591162 | 19 | Product used for unknown indication |
| 125911621 | 12591162 | 20 | Product used for unknown indication |
| 125911621 | 12591162 | 21 | Product used for unknown indication |
| 125911621 | 12591162 | 22 | Product used for unknown indication |
| 125911621 | 12591162 | 23 | Product used for unknown indication |
| 125911621 | 12591162 | 24 | Product used for unknown indication |
| 125911621 | 12591162 | 25 | Product used for unknown indication |
| 125911621 | 12591162 | 26 | Product used for unknown indication |
| 125911621 | 12591162 | 27 | Product used for unknown indication |
| 125911621 | 12591162 | 28 | Product used for unknown indication |
| 125911621 | 12591162 | 29 | Product used for unknown indication |
| 125911621 | 12591162 | 30 | Product used for unknown indication |
| 125911621 | 12591162 | 31 | Product used for unknown indication |
| 125911621 | 12591162 | 32 | Product used for unknown indication |
| 125911621 | 12591162 | 33 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125911621 | 12591162 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125911621 | 12591162 | Abdominal discomfort | |
| 125911621 | 12591162 | Dehydration | |
| 125911621 | 12591162 | Diarrhoea | |
| 125911621 | 12591162 | Headache | |
| 125911621 | 12591162 | Heart rate abnormal | |
| 125911621 | 12591162 | Hypotension | |
| 125911621 | 12591162 | Migraine | |
| 125911621 | 12591162 | Palpitations | |
| 125911621 | 12591162 | Supraventricular tachycardia |
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 |
|---|---|---|---|---|---|---|
| 125911621 | 12591162 | 1 | 20151211 | 0 | ||
| 125911621 | 12591162 | 12 | 20141217 | 0 |