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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125745693 | 12574569 | 3 | F | 2016 | 20160817 | 20160720 | 20160824 | EXP | US-UNITED THERAPEUTICS-UNT-2016-011078 | UNITED THERAPEUTICS | 57.07 | YR | F | Y | 65.31000 | KG | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125745693 | 12574569 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.12 ?G/KG, CONTINUING | U | U | 2100701 | 21272 | .12 | UG/KG | INJECTION | ||||
| 125745693 | 12574569 | 2 | C | ADEMPAS | RIOCIGUAT | 1 | 0 | ||||||||||||
| 125745693 | 12574569 | 3 | C | OPSUMIT | MACITENTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125745693 | 12574569 | 1 | Pulmonary arterial hypertension |
| 125745693 | 12574569 | 2 | Product used for unknown indication |
| 125745693 | 12574569 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125745693 | 12574569 | OT |
| 125745693 | 12574569 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125745693 | 12574569 | Administration site urticaria | |
| 125745693 | 12574569 | Chills | |
| 125745693 | 12574569 | Dehydration | |
| 125745693 | 12574569 | Diarrhoea | |
| 125745693 | 12574569 | Hypokalaemia | |
| 125745693 | 12574569 | Infusion site oedema | |
| 125745693 | 12574569 | Infusion site pain | |
| 125745693 | 12574569 | Loss of consciousness | |
| 125745693 | 12574569 | Lymphadenopathy | |
| 125745693 | 12574569 | Muscle spasms | |
| 125745693 | 12574569 | Pneumonia | |
| 125745693 | 12574569 | Pyrexia | |
| 125745693 | 12574569 | Syncope | |
| 125745693 | 12574569 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 125745693 | 12574569 | 1 | 20140220 | 0 |