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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123559594 | 12355959 | 4 | F | 201604 | 20160726 | 20160511 | 20160809 | EXP | US-ACTELION-A-US2016-135852 | ACTELION | 70.00 | YR | E | M | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123559594 | 12355959 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP021P0101,OP023P0101, OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 123559594 | 12355959 | 2 | C | OXYGEN. | OXYGEN | 1 | 2 L, UNK | U | 0 | 2 | L |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123559594 | 12355959 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123559594 | 12355959 | OT |
| 123559594 | 12355959 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123559594 | 12355959 | Cerebrovascular accident | |
| 123559594 | 12355959 | Drooling | |
| 123559594 | 12355959 | Dyspnoea | |
| 123559594 | 12355959 | Facial paralysis | |
| 123559594 | 12355959 | Fall | |
| 123559594 | 12355959 | Multiple organ dysfunction syndrome | |
| 123559594 | 12355959 | Musculoskeletal disorder | |
| 123559594 | 12355959 | Nervous system disorder | |
| 123559594 | 12355959 | Oedema peripheral | |
| 123559594 | 12355959 | Respiratory arrest | |
| 123559594 | 12355959 | Syncope | |
| 123559594 | 12355959 | Wound drainage |
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 |
|---|---|---|---|---|---|---|
| 123559594 | 12355959 | 1 | 20090720 | 0 |