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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125024032 | 12502403 | 2 | F | 20160513 | 20160720 | 20160627 | 20160729 | EXP | DE-ACTELION-A-NJ2016-136795 | ACTELION | 56.00 | YR | A | F | Y | 0.00000 | 20160729 | OT | DE | CL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125024032 | 12502403 | 1 | PS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 0.5 ML, 8/D | 21779 | .5 | ML | INHALATION VAPOUR, SOLUTION | |||||||
| 125024032 | 12502403 | 2 | C | TRACLEER | BOSENTAN | 1 | U | 21290 | TABLET | ||||||||||
| 125024032 | 12502403 | 3 | C | NEBIVOLOL. | NEBIVOLOL | 1 | U | 0 | |||||||||||
| 125024032 | 12502403 | 4 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | U | 0 | |||||||||||
| 125024032 | 12502403 | 5 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 125024032 | 12502403 | 6 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 | |||||||||||
| 125024032 | 12502403 | 7 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | U | 0 | |||||||||||
| 125024032 | 12502403 | 8 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 125024032 | 12502403 | 9 | C | NEO-SINTROM | ACENOCOUMAROL | 1 | U | 0 | |||||||||||
| 125024032 | 12502403 | 10 | C | DIGENIL | 2 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125024032 | 12502403 | 1 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125024032 | 12502403 | OT |
| 125024032 | 12502403 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125024032 | 12502403 | Abdominal pain upper | |
| 125024032 | 12502403 | Bile duct stone | |
| 125024032 | 12502403 | Bradycardia | |
| 125024032 | 12502403 | Cardiac pacemaker insertion | |
| 125024032 | 12502403 | Drug-induced liver injury | |
| 125024032 | 12502403 | Hepatic cyst | |
| 125024032 | 12502403 | Influenza | |
| 125024032 | 12502403 | Oedema peripheral | |
| 125024032 | 12502403 | Pain in extremity | |
| 125024032 | 12502403 | Peripheral swelling | |
| 125024032 | 12502403 | Pulmonary hypertension | |
| 125024032 | 12502403 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 125024032 | 12502403 | 1 | 20151211 | 0 |