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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122350734 | 12235073 | 4 | F | 20160321 | 20160823 | 20160404 | 20160901 | EXP | US-ACTELION-A-US2016-132812 | ACTELION | 53.00 | YR | A | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122350734 | 12235073 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | Y | 21290 | 125 | MG | TABLET | BID | |||||
| 122350734 | 12235073 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | Y | OP019P0101 | 21290 | TABLET | |||||||
| 122350734 | 12235073 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, UNK | Y | OP019P0101, NP014P0201 | 21290 | 62.5 | MG | TABLET | |||||
| 122350734 | 12235073 | 4 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, UNK | Y | NP014P0201 | 21290 | 62.5 | MG | TABLET | |||||
| 122350734 | 12235073 | 5 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 43 NG/KG, PER MIN | MM082M0101, MM090M0101 | 22260 | INJECTION | /min | |||||||
| 122350734 | 12235073 | 6 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 92 NG/KG, PER MIN | 22260 | INJECTION | /min | ||||||||
| 122350734 | 12235073 | 7 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 44.5 NG/KG, PER MIN | MM090M0101 | 22260 | INJECTION | /min | |||||||
| 122350734 | 12235073 | 8 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122350734 | 12235073 | 1 | Pulmonary arterial hypertension |
| 122350734 | 12235073 | 5 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122350734 | 12235073 | HO |
| 122350734 | 12235073 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122350734 | 12235073 | Choking | |
| 122350734 | 12235073 | Cough | |
| 122350734 | 12235073 | Dyspnoea | |
| 122350734 | 12235073 | Headache | |
| 122350734 | 12235073 | Influenza | |
| 122350734 | 12235073 | Migraine | |
| 122350734 | 12235073 | Pain | |
| 122350734 | 12235073 | Pain in extremity | |
| 122350734 | 12235073 | Pneumonia | |
| 122350734 | 12235073 | Thyroid mass |
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 |
|---|---|---|---|---|---|---|
| 122350734 | 12235073 | 2 | 200801 | 0 | ||
| 122350734 | 12235073 | 3 | 20160222 | 0 | ||
| 122350734 | 12235073 | 4 | 20151009 | 0 | ||
| 122350734 | 12235073 | 5 | 20110221 | 0 | ||
| 122350734 | 12235073 | 7 | 20110221 | 0 |