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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125949351 | 12594935 | 1 | I | 201602 | 20160223 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-003053 | UNITED THERAPEUTICS | 61.41 | YR | F | Y | 53.97000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125949351 | 12594935 | 1 | PS | TYVASO | TREPROSTINIL | 1 | 18-72 MICROGRAMS, QID | U | U | 2100716 | 22387 | INHALATION GAS | QID | ||||||
| 125949351 | 12594935 | 2 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | 2 UNK, QD | U | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125949351 | 12594935 | 1 | Pulmonary hypertension |
| 125949351 | 12594935 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125949351 | 12594935 | Oedema | |
| 125949351 | 12594935 | Oedema peripheral | |
| 125949351 | 12594935 | 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 |
|---|---|---|---|---|---|---|
| 125949351 | 12594935 | 1 | 20151013 | 0 | ||
| 125949351 | 12594935 | 2 | 201602 | 0 |