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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113189076 | 11318907 | 6 | F | 20150423 | 20160824 | 20150729 | 20160906 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2015-117001 | ACTELION | 46.00 | YR | A | F | Y | 0.00000 | 20160907 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113189076 | 11318907 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM012N0501,UM017N0201,UM016A0201 | 204410 | 10 | MG | TABLET | QD | |||||
| 113189076 | 11318907 | 2 | SS | UPTRAVI | SELEXIPAG | 1 | Oral | U | U | 207947 | TABLET | ||||||||
| 113189076 | 11318907 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 113189076 | 11318907 | 4 | C | RIOCIGUAT | RIOCIGUAT | 1 | U | 0 | |||||||||||
| 113189076 | 11318907 | 5 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 113189076 | 11318907 | 6 | C | XARELTO | RIVAROXABAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113189076 | 11318907 | 1 | Pulmonary arterial hypertension |
| 113189076 | 11318907 | 2 | Pulmonary arterial hypertension |
| 113189076 | 11318907 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113189076 | 11318907 | Abdominal discomfort | |
| 113189076 | 11318907 | Abdominal pain | |
| 113189076 | 11318907 | Abdominal pain upper | |
| 113189076 | 11318907 | Asthenia | |
| 113189076 | 11318907 | Bacterial infection | |
| 113189076 | 11318907 | Catheter site pruritus | |
| 113189076 | 11318907 | Diarrhoea | |
| 113189076 | 11318907 | Dizziness | |
| 113189076 | 11318907 | Drug dose omission | |
| 113189076 | 11318907 | Dyspnoea | |
| 113189076 | 11318907 | Fatigue | |
| 113189076 | 11318907 | Headache | |
| 113189076 | 11318907 | Incorrect dose administered | |
| 113189076 | 11318907 | Limb discomfort | |
| 113189076 | 11318907 | Malaise | |
| 113189076 | 11318907 | Myalgia | |
| 113189076 | 11318907 | Nausea | |
| 113189076 | 11318907 | Peripheral swelling | |
| 113189076 | 11318907 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 113189076 | 11318907 | 1 | 20140407 | 0 |