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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123727974 | 12372797 | 4 | F | 201511 | 20160720 | 20160516 | 20160728 | EXP | US-UNITED THERAPEUTICS-UNT-2016-003321 | UNITED THERAPEUTICS | 70.32 | YR | M | Y | 65.76000 | KG | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123727974 | 12372797 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.043 ?G/KG, CONTINUING | U | U | 926618 | 21272 | .043 | UG/KG | INJECTION | ||||
| 123727974 | 12372797 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | U | U | 2100909 | 21272 | INJECTION | |||||||
| 123727974 | 12372797 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.049 ?G/KG, CONTINUING | U | U | 929005 | 21272 | .049 | UG/KG | INJECTION | ||||
| 123727974 | 12372797 | 4 | SS | OPSUMIT | MACITENTAN | 1 | UNK | Y | 0 | ||||||||||
| 123727974 | 12372797 | 5 | C | DIGOXIN. | DIGOXIN | 1 | 0.25 MG, QD | 0 | .25 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123727974 | 12372797 | 1 | Pulmonary arterial hypertension |
| 123727974 | 12372797 | 4 | Product used for unknown indication |
| 123727974 | 12372797 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123727974 | 12372797 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123727974 | 12372797 | Anaemia | |
| 123727974 | 12372797 | Chills | |
| 123727974 | 12372797 | Diarrhoea | |
| 123727974 | 12372797 | Epistaxis | |
| 123727974 | 12372797 | Fungal infection | |
| 123727974 | 12372797 | Headache | |
| 123727974 | 12372797 | Loss of consciousness | |
| 123727974 | 12372797 | Malaise | |
| 123727974 | 12372797 | Nausea | |
| 123727974 | 12372797 | Oxygen consumption increased | |
| 123727974 | 12372797 | Oxygen saturation decreased | |
| 123727974 | 12372797 | Pain in extremity | |
| 123727974 | 12372797 | Pain in jaw | |
| 123727974 | 12372797 | Syncope | |
| 123727974 | 12372797 | Vomiting | |
| 123727974 | 12372797 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 123727974 | 12372797 | 1 | 20140220 | 0 | ||
| 123727974 | 12372797 | 4 | 20160127 | 0 |