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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124955875 | 12495587 | 5 | F | 201605 | 20160802 | 20160624 | 20160810 | EXP | US-UNITED THERAPEUTICS-UNT-2016-008225 | UNITED THERAPEUTICS | 16.80 | YR | F | Y | 53.61000 | KG | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124955875 | 12495587 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.035 ?G/KG, CONTINUING | 21272 | .035 | UG/KG | INJECTION | |||||||
| 124955875 | 12495587 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.015 ?G/KG, CONTINUING | 2100431 | 21272 | .015 | UG/KG | INJECTION | ||||||
| 124955875 | 12495587 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | 2100954 | 21272 | INJECTION | |||||||||
| 124955875 | 12495587 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | 2100498 | 21272 | INJECTION | |||||||||
| 124955875 | 12495587 | 5 | C | OPSUMIT | MACITENTAN | 1 | 0 | ||||||||||||
| 124955875 | 12495587 | 6 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124955875 | 12495587 | 1 | Pulmonary arterial hypertension |
| 124955875 | 12495587 | 5 | Product used for unknown indication |
| 124955875 | 12495587 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124955875 | 12495587 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124955875 | 12495587 | Axillary mass | |
| 124955875 | 12495587 | Axillary pain | |
| 124955875 | 12495587 | Dermatitis contact | |
| 124955875 | 12495587 | Device dislocation | |
| 124955875 | 12495587 | Diarrhoea | |
| 124955875 | 12495587 | Injection site pruritus | |
| 124955875 | 12495587 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 124955875 | 12495587 | 1 | 20160511 | 0 | ||
| 124955875 | 12495587 | 2 | 20160523 | 0 |