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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125908891 | 12590889 | 1 | I | 201604 | 20160408 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-005921 | UNITED THERAPEUTICS | 65.24 | YR | M | Y | 50.79000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125908891 | 12590889 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1 MG, BID | 2100476 | 203496 | 1 | MG | TABLET | BID | |||||
| 125908891 | 12590889 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 4.25 MG, BID | 2100679 | 203496 | 4.25 | MG | TABLET | BID | |||||
| 125908891 | 12590889 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2 MG, BID | 2100477 | 203496 | 2 | MG | TABLET | BID | |||||
| 125908891 | 12590889 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5.5 MG, BID | 2100476 | 203496 | 5.5 | MG | TABLET | BID | |||||
| 125908891 | 12590889 | 5 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.027 ?G/KG, CONTINUING | 926618 | 0 | .027 | UG/KG | INJECTION | ||||||
| 125908891 | 12590889 | 6 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.001 ?G/KG, UNK | 0 | .001 | UG/KG | INJECTION | |||||||
| 125908891 | 12590889 | 7 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 125908891 | 12590889 | 8 | C | REVATIO | SILDENAFIL CITRATE | 1 | 0 | ||||||||||||
| 125908891 | 12590889 | 9 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125908891 | 12590889 | 1 | Pulmonary arterial hypertension |
| 125908891 | 12590889 | 2 | Pulmonary hypertension |
| 125908891 | 12590889 | 5 | Pulmonary hypertension |
| 125908891 | 12590889 | 6 | Pulmonary arterial hypertension |
| 125908891 | 12590889 | 7 | Product used for unknown indication |
| 125908891 | 12590889 | 8 | Product used for unknown indication |
| 125908891 | 12590889 | 9 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125908891 | 12590889 | Anxiety | |
| 125908891 | 12590889 | Asthenia | |
| 125908891 | 12590889 | Cough | |
| 125908891 | 12590889 | Dyspnoea | |
| 125908891 | 12590889 | Fatigue | |
| 125908891 | 12590889 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 125908891 | 12590889 | 1 | 20160328 | 0 | ||
| 125908891 | 12590889 | 5 | 20110217 | 0 |