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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945421 | 12594542 | 1 | I | 20160504 | 20160504 | 20160726 | 20160726 | EXP | US-UNITED THERAPEUTICS-UNT-2016-007356 | UNITED THERAPEUTICS | 15.02 | YR | F | Y | 64.00000 | KG | 20160726 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945421 | 12594542 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.097 ?G/KG, CONTINUING | Y | U | 2100701 | 21272 | .097 | UG/KG | INJECTION | ||||
| 125945421 | 12594542 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.102 ?G/KG, CONTINUING | Y | U | 21272 | .102 | UG/KG | INJECTION | |||||
| 125945421 | 12594542 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 5 MG, QD | 1412805A | 0 | 5 | MG | TABLET | QD | |||||
| 125945421 | 12594542 | 4 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | 1504767A | 0 | 10 | MG | TABLET | QD | |||||
| 125945421 | 12594542 | 5 | C | ADCIRCA | TADALAFIL | 1 | UNK | 0 | |||||||||||
| 125945421 | 12594542 | 6 | C | WARFARIN | WARFARIN | 1 | 0 | ||||||||||||
| 125945421 | 12594542 | 7 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | 0 | ||||||||||||
| 125945421 | 12594542 | 8 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | 0 | ||||||||||||
| 125945421 | 12594542 | 9 | C | LORATADINE. | LORATADINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125945421 | 12594542 | 1 | Pulmonary arterial hypertension |
| 125945421 | 12594542 | 2 | Pulmonary hypertension |
| 125945421 | 12594542 | 3 | Pulmonary arterial hypertension |
| 125945421 | 12594542 | 5 | Product used for unknown indication |
| 125945421 | 12594542 | 6 | Product used for unknown indication |
| 125945421 | 12594542 | 7 | Product used for unknown indication |
| 125945421 | 12594542 | 8 | Product used for unknown indication |
| 125945421 | 12594542 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125945421 | 12594542 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125945421 | 12594542 | Device dislocation | |
| 125945421 | 12594542 | Drug dose omission | |
| 125945421 | 12594542 | Infusion site abscess | |
| 125945421 | 12594542 | Infusion site cellulitis | |
| 125945421 | 12594542 | Infusion site pain |
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 |
|---|---|---|---|---|---|---|
| 125945421 | 12594542 | 1 | 20140201 | 0 | ||
| 125945421 | 12594542 | 2 | 20160111 | 0 | ||
| 125945421 | 12594542 | 3 | 20160426 | 0 | ||
| 125945421 | 12594542 | 5 | 201603 | 0 |