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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126216121 | 12621612 | 1 | I | 20160116 | 20160504 | 20160804 | 20160804 | EXP | HU-ACTELION-A-CH2016-135713 | ACTELION | 62.00 | YR | A | F | Y | 0.00000 | 20160804 | OT | HU | HU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126216121 | 12621612 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | Y | 21290 | 125 | MG | TABLET | BID | |||||
| 126216121 | 12621612 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | Y | 21290 | 62.5 | MG | TABLET | BID | |||||
| 126216121 | 12621612 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | Y | 21290 | 62.5 | MG | TABLET | BID | |||||
| 126216121 | 12621612 | 4 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 150 ?G, UNK | U | U | 0 | 150 | UG | ||||||
| 126216121 | 12621612 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 2.5 MG, BID | U | U | 0 | 2.5 | MG | BID | |||||
| 126216121 | 12621612 | 6 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, BID | U | U | 0 | 40 | MG | BID | |||||
| 126216121 | 12621612 | 7 | C | RIVAROXABAN | RIVAROXABAN | 1 | Oral | 15 MG, UNK | U | U | 0 | 15 | MG | ||||||
| 126216121 | 12621612 | 8 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 2.5 MG, UNK | U | U | 0 | 2.5 | MG | ||||||
| 126216121 | 12621612 | 9 | C | ADEXOR | 2 | Oral | 35 MG, BID | U | U | 0 | 35 | MG | BID | ||||||
| 126216121 | 12621612 | 10 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, BID | U | U | 0 | 25 | MG | BID | |||||
| 126216121 | 12621612 | 11 | C | XARELTO | RIVAROXABAN | 1 | Oral | 15 MG, UNK | U | U | 0 | 15 | MG | ||||||
| 126216121 | 12621612 | 12 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG, UNK | U | U | 0 | 40 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126216121 | 12621612 | 1 | Pulmonary arterial hypertension |
| 126216121 | 12621612 | 4 | Hypothyroidism |
| 126216121 | 12621612 | 5 | Hypertension |
| 126216121 | 12621612 | 6 | Gastrooesophageal reflux disease |
| 126216121 | 12621612 | 7 | Atrial fibrillation |
| 126216121 | 12621612 | 8 | Atrial fibrillation |
| 126216121 | 12621612 | 9 | Myocardial ischaemia |
| 126216121 | 12621612 | 10 | Cardiac failure |
| 126216121 | 12621612 | 11 | Atrial fibrillation |
| 126216121 | 12621612 | 12 | Cardiac failure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126216121 | 12621612 | OT |
| 126216121 | 12621612 | DE |
| 126216121 | 12621612 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126216121 | 12621612 | Aortic stenosis | |
| 126216121 | 12621612 | Ascites | |
| 126216121 | 12621612 | Asthenia | |
| 126216121 | 12621612 | Cardiac failure | |
| 126216121 | 12621612 | Cardiopulmonary failure | |
| 126216121 | 12621612 | Condition aggravated | |
| 126216121 | 12621612 | Disease progression | |
| 126216121 | 12621612 | Dyspnoea | |
| 126216121 | 12621612 | Fluid retention | |
| 126216121 | 12621612 | Hepatic failure | |
| 126216121 | 12621612 | Hepatomegaly | |
| 126216121 | 12621612 | Nausea | |
| 126216121 | 12621612 | Oedema peripheral | |
| 126216121 | 12621612 | Pulmonary arterial hypertension | |
| 126216121 | 12621612 | Right ventricular failure | |
| 126216121 | 12621612 | Splenomegaly |
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 |
|---|---|---|---|---|---|---|
| 126216121 | 12621612 | 1 | 20130426 | 20160624 | 0 | |
| 126216121 | 12621612 | 2 | 20130130 | 20130425 | 0 | |
| 126216121 | 12621612 | 3 | 20160626 | 20160705 | 0 |