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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110954557 | 11095455 | 7 | F | 201504 | 20160808 | 20150506 | 20160818 | EXP | US-ACTELION-A-NJ2015-116041 | ACTELION | 73.00 | YR | E | M | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110954557 | 11095455 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP053P0101,IP054P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 110954557 | 11095455 | 2 | C | SILDENAFIL. | SILDENAFIL | 1 | 20 MG, QPM | U | 0 | 20 | MG | QD | |||||||
| 110954557 | 11095455 | 3 | C | TYVASO | TREPROSTINIL | 1 | Respiratory (inhalation) | UNK, QID | U | 0 | QID | ||||||||
| 110954557 | 11095455 | 4 | C | PREDNISONE. | PREDNISONE | 1 | UNK, BID | U | 0 | ||||||||||
| 110954557 | 11095455 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 10 MG, UNK | U | 0 | 10 | MG | QD | |||||||
| 110954557 | 11095455 | 6 | C | LASIX | FUROSEMIDE | 1 | 40 MG, UNK | U | 0 | 40 | MG | QD | |||||||
| 110954557 | 11095455 | 7 | C | DILTIAZEM CD | DILTIAZEM | 1 | U | 0 | |||||||||||
| 110954557 | 11095455 | 8 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | U | 0 | |||||||||||
| 110954557 | 11095455 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | U | 0 | |||||||||||
| 110954557 | 11095455 | 10 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | U | 0 | |||||||||||
| 110954557 | 11095455 | 11 | C | GLIPIZIDE. | GLIPIZIDE | 1 | U | 0 | |||||||||||
| 110954557 | 11095455 | 12 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | U | 0 | |||||||||||
| 110954557 | 11095455 | 13 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110954557 | 11095455 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110954557 | 11095455 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110954557 | 11095455 | Diarrhoea | |
| 110954557 | 11095455 | Dyspnoea | |
| 110954557 | 11095455 | Food poisoning | |
| 110954557 | 11095455 | Influenza | |
| 110954557 | 11095455 | Lethargy | |
| 110954557 | 11095455 | Nasal congestion | |
| 110954557 | 11095455 | Nasopharyngitis | |
| 110954557 | 11095455 | Oxygen saturation decreased | |
| 110954557 | 11095455 | Pulmonary arterial hypertension | |
| 110954557 | 11095455 | Respiratory tract infection | |
| 110954557 | 11095455 | Tooth extraction | |
| 110954557 | 11095455 | Upper respiratory tract infection | |
| 110954557 | 11095455 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 110954557 | 11095455 | 1 | 20141021 | 0 | ||
| 110954557 | 11095455 | 2 | 20150427 | 0 | ||
| 110954557 | 11095455 | 4 | 20150326 | 0 | ||
| 110954557 | 11095455 | 6 | 20141219 | 0 |