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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122459408 | 12245940 | 8 | F | 20160919 | 20160407 | 20160928 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-US2016-133619 | ACTELION | 62.00 | YR | A | F | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122459408 | 12245940 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP021P0101,OP023P0101,OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 122459408 | 12245940 | 2 | C | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | 2 MG, TID | 0 | 2 | MG | TID | ||||||||
| 122459408 | 12245940 | 3 | C | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | 2.5 MG, TID | 0 | 2.5 | MG | TID | ||||||||
| 122459408 | 12245940 | 4 | C | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | 3.75 MG, UNK | 0 | 3.75 | MG | |||||||||
| 122459408 | 12245940 | 5 | C | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | 2.875 MG, UNK | 0 | 2.875 | MG | |||||||||
| 122459408 | 12245940 | 6 | C | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | UNK | 0 | |||||||||||
| 122459408 | 12245940 | 7 | C | TYVASO | TREPROSTINIL | 1 | Respiratory (inhalation) | DECREASING TO 3 BREATHS, QID | U | 0 | QID | ||||||||
| 122459408 | 12245940 | 8 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 122459408 | 12245940 | 9 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 122459408 | 12245940 | 10 | C | CARDIZEM | DILTIAZEM HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122459408 | 12245940 | 1 | Pulmonary arterial hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122459408 | 12245940 | Asthenia | |
| 122459408 | 12245940 | Chills | |
| 122459408 | 12245940 | Dyspnoea exertional | |
| 122459408 | 12245940 | Flushing | |
| 122459408 | 12245940 | Headache | |
| 122459408 | 12245940 | Nausea | |
| 122459408 | 12245940 | Pain | |
| 122459408 | 12245940 | Pain in extremity | |
| 122459408 | 12245940 | Pain in jaw | |
| 122459408 | 12245940 | 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 |
|---|---|---|---|---|---|---|
| 122459408 | 12245940 | 1 | 20160315 | 0 | ||
| 122459408 | 12245940 | 2 | 20160326 | 0 | ||
| 122459408 | 12245940 | 3 | 20160331 | 0 | ||
| 122459408 | 12245940 | 7 | 20160326 | 0 |