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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119433762 | 11943376 | 2 | F | 201509 | 20160328 | 20160125 | 20160729 | EXP | US-UNITED THERAPEUTICS-UNT-2015-011127 | UNITED THERAPEUTICS | 47.02 | YR | F | Y | 68.27000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119433762 | 11943376 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.092 ?G/KG/MIN, CONTINUING | Y | 924715 | 21272 | .092 | UG/KG | INJECTION | |||||
| 119433762 | 11943376 | 2 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | SBFX | 0 | 10 | MG | TABLET | QD | |||||
| 119433762 | 11943376 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | 0 | TABLET | |||||||||||
| 119433762 | 11943376 | 4 | C | REVATIO | SILDENAFIL CITRATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119433762 | 11943376 | 1 | Pulmonary hypertension |
| 119433762 | 11943376 | 2 | Pulmonary hypertension |
| 119433762 | 11943376 | 3 | Drug abuse |
| 119433762 | 11943376 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119433762 | 11943376 | HO |
| 119433762 | 11943376 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119433762 | 11943376 | Accidental overdose | |
| 119433762 | 11943376 | Complication associated with device | |
| 119433762 | 11943376 | Dermatitis contact | |
| 119433762 | 11943376 | Device dislocation | |
| 119433762 | 11943376 | Device occlusion | |
| 119433762 | 11943376 | Drug dose omission | |
| 119433762 | 11943376 | Flushing | |
| 119433762 | 11943376 | Herpes zoster | |
| 119433762 | 11943376 | Injection site cellulitis | |
| 119433762 | 11943376 | Injection site discharge | |
| 119433762 | 11943376 | Injection site exfoliation | |
| 119433762 | 11943376 | Injection site infection | |
| 119433762 | 11943376 | Injection site pain | |
| 119433762 | 11943376 | Injection site pruritus | |
| 119433762 | 11943376 | Malaise | |
| 119433762 | 11943376 | Nausea | |
| 119433762 | 11943376 | Pruritus generalised | |
| 119433762 | 11943376 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 119433762 | 11943376 | 1 | 20140806 | 20151213 | 0 | |
| 119433762 | 11943376 | 2 | 20130404 | 0 |