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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123950672 | 12395067 | 2 | F | 20160706 | 20160719 | 20160523 | 20160729 | EXP | US-ACTELION-A-US2016-132323 | ACTELION | 52.00 | YR | A | F | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123950672 | 12395067 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | DP061P0112, NP013P0402, NP014P0201 | 21290 | 62.5 | MG | TABLET | BID | |||||
| 123950672 | 12395067 | 2 | C | CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123950672 | 12395067 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123950672 | 12395067 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123950672 | 12395067 | Asthenia | |
| 123950672 | 12395067 | Cardiac failure congestive | |
| 123950672 | 12395067 | Dyspnoea | |
| 123950672 | 12395067 | Hypotension | |
| 123950672 | 12395067 | Lethargy | |
| 123950672 | 12395067 | Pericardial effusion | |
| 123950672 | 12395067 | Pleural effusion | |
| 123950672 | 12395067 | Pneumonia | |
| 123950672 | 12395067 | Respiratory distress | |
| 123950672 | 12395067 | Syncope | |
| 123950672 | 12395067 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 123950672 | 12395067 | 1 | 20160211 | 0 |