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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123601373 | 12360137 | 3 | F | 20160411 | 20160912 | 20160512 | 20160926 | EXP | US-ACTELION-A-US2016-135724 | ACTELION | 54.00 | YR | A | F | Y | 0.00000 | 20160926 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123601373 | 12360137 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | 204410 | 10 | MG | TABLET | QD | ||||||
| 123601373 | 12360137 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Unknown | Y | 0 | ||||||||||
| 123601373 | 12360137 | 3 | SS | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | Unknown | 2.5 MG, TID | U | 0 | 2.5 | MG | TID | ||||||
| 123601373 | 12360137 | 4 | SS | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | Unknown | 2.625 MG, QAM | U | 0 | 2.625 | MG | QD | ||||||
| 123601373 | 12360137 | 5 | SS | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | Unknown | 2.5 MG, BID | U | 0 | 2.5 | MG | BID | ||||||
| 123601373 | 12360137 | 6 | SS | RIOCIGUAT | RIOCIGUAT | 1 | Unknown | 2 MG, TID | 0 | 2 | MG | TID | |||||||
| 123601373 | 12360137 | 7 | SS | RIOCIGUAT | RIOCIGUAT | 1 | Unknown | 2.5 UNK, UNK | 0 | 2.5 | MG | TID | |||||||
| 123601373 | 12360137 | 8 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 | |||||||||||
| 123601373 | 12360137 | 9 | C | DIGOXIN. | DIGOXIN | 1 | U | 0 | |||||||||||
| 123601373 | 12360137 | 10 | C | BUMEX | BUMETANIDE | 1 | U | 0 | |||||||||||
| 123601373 | 12360137 | 11 | C | OXYCODONE | OXYCODONE | 1 | U | 0 | |||||||||||
| 123601373 | 12360137 | 12 | C | LOSARTAN. | LOSARTAN | 1 | U | 0 | |||||||||||
| 123601373 | 12360137 | 13 | C | FUROSEMIDE. | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 123601373 | 12360137 | 14 | C | DOXEPIN | DOXEPIN | 1 | U | 0 | |||||||||||
| 123601373 | 12360137 | 15 | C | XARELTO | RIVAROXABAN | 1 | U | 0 | |||||||||||
| 123601373 | 12360137 | 16 | C | METOPROLOL. | METOPROLOL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123601373 | 12360137 | 1 | Pulmonary hypertension |
| 123601373 | 12360137 | 2 | Product used for unknown indication |
| 123601373 | 12360137 | 3 | Product used for unknown indication |
| 123601373 | 12360137 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123601373 | 12360137 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123601373 | 12360137 | Connective tissue disorder | |
| 123601373 | 12360137 | Headache | |
| 123601373 | 12360137 | Lung disorder | |
| 123601373 | 12360137 | Nausea | |
| 123601373 | 12360137 | Pain in jaw | |
| 123601373 | 12360137 | Pulmonary hypertension | |
| 123601373 | 12360137 | Pulmonary veno-occlusive disease | |
| 123601373 | 12360137 | Walking distance test abnormal |
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 |
|---|---|---|---|---|---|---|
| 123601373 | 12360137 | 1 | 20160321 | 0 | ||
| 123601373 | 12360137 | 6 | 20160220 | 0 |