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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116992754 | 11699275 | 4 | F | 20151024 | 20160912 | 20151104 | 20160923 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2015-126733 | ACTELION | 37.00 | YR | A | F | Y | 41.27000 | KG | 20160923 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116992754 | 11699275 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | UNK, BID | IP053P0101,OP019P0101, OP206P0101 | 21290 | TABLET | BID | |||||||
| 116992754 | 11699275 | 2 | C | COUMADIN | WARFARIN SODIUM | 1 | 8 MG, UNK | U | 0 | 8 | MG | ||||||||
| 116992754 | 11699275 | 3 | C | LASIX | FUROSEMIDE | 1 | 40 MG, BID | 0 | 40 | MG | BID | ||||||||
| 116992754 | 11699275 | 4 | C | VASOTEC | ENALAPRIL MALEATE | 1 | 5 MG, BID | U | 0 | 5 | MG | BID | |||||||
| 116992754 | 11699275 | 5 | C | DILTIAZEM HCL EXTE-REL | DILTIAZEM HYDROCHLORIDE | 1 | 120 MG, UNK | U | 0 | 120 | MG | ||||||||
| 116992754 | 11699275 | 6 | C | DIGOXIN. | DIGOXIN | 1 | 0.25 MG, UNK | U | 0 | .25 | MG | ||||||||
| 116992754 | 11699275 | 7 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | 250 MG, QD | U | 0 | 250 | MG | QD | |||||||
| 116992754 | 11699275 | 8 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | 6.25-15 MG/ML, Q6HRS | U | 0 | QID | |||||||||
| 116992754 | 11699275 | 9 | C | ALBUTEROL. | ALBUTEROL | 1 | 2.5 MG/M3, Q6HRS | U | 0 | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116992754 | 11699275 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116992754 | 11699275 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116992754 | 11699275 | Abdominal distension | |
| 116992754 | 11699275 | Dyspnoea | |
| 116992754 | 11699275 | Fatigue | |
| 116992754 | 11699275 | Fluid retention | |
| 116992754 | 11699275 | Joint swelling | |
| 116992754 | 11699275 | Ligament sprain | |
| 116992754 | 11699275 | Oedema peripheral | |
| 116992754 | 11699275 | Pain in extremity | |
| 116992754 | 11699275 | Pulmonary congestion | |
| 116992754 | 11699275 | 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 |
|---|---|---|---|---|---|---|
| 116992754 | 11699275 | 1 | 20121116 | 0 |