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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125911592 | 12591159 | 2 | F | 20160219 | 20160613 | 20160726 | 20160727 | PER | US-UNITED THERAPEUTICS-UNT-2016-004486 | UNITED THERAPEUTICS | 48.21 | YR | F | Y | 60.32000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125911592 | 12591159 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.031 ?G/KG, CONTINUING | 2100666 | 21272 | .031 | UG/KG | INJECTION | ||||||
| 125911592 | 12591159 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | UNK | 2100701 | 21272 | INJECTION | ||||||||
| 125911592 | 12591159 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | U | 0 | ||||||||||
| 125911592 | 12591159 | 4 | C | LETAIRIS | AMBRISENTAN | 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125911592 | 12591159 | 1 | Pulmonary hypertension |
| 125911592 | 12591159 | 3 | Product used for unknown indication |
| 125911592 | 12591159 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125911592 | 12591159 | Back pain | |
| 125911592 | 12591159 | Blood pressure increased | |
| 125911592 | 12591159 | Dry mouth | |
| 125911592 | 12591159 | Dyspnoea | |
| 125911592 | 12591159 | Fatigue | |
| 125911592 | 12591159 | Frustration tolerance decreased | |
| 125911592 | 12591159 | Infusion site erythema | |
| 125911592 | 12591159 | Infusion site nodule | |
| 125911592 | 12591159 | Infusion site oedema | |
| 125911592 | 12591159 | Infusion site pain | |
| 125911592 | 12591159 | Infusion site reaction | |
| 125911592 | 12591159 | Malaise | |
| 125911592 | 12591159 | Muscle spasms | |
| 125911592 | 12591159 | Nausea | |
| 125911592 | 12591159 | Pain | |
| 125911592 | 12591159 | Pain in extremity | |
| 125911592 | 12591159 | Retching | |
| 125911592 | 12591159 | 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 |
|---|---|---|---|---|---|---|
| 125911592 | 12591159 | 1 | 20160219 | 0 |