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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90529194 | 9052919 | 4 | F | 20121212 | 20160705 | 20130207 | 20160715 | EXP | JP-GILEAD-2012-0066993 | GILEAD | MAKI H, ET AL.. A REPORT ON SEROUS OTITIS MEDIA DEVELOPED DURING TREATMENT WITH CONTINUOUS INTRAVENOUS INFUSION OF EPOPROSTENOL.. JOURNAL OF CARDIOLOGY. 2013;8 (S1):693- | 48.00 | YR | A | F | Y | 0.00000 | 20160715 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90529194 | 9052919 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 10 MG, QD | 22081 | 10 | MG | TABLET | QD | ||||||
| 90529194 | 9052919 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 0 | INJECTION | ||||||||||
| 90529194 | 9052919 | 3 | C | ADCIRCA | TADALAFIL | 1 | Oral | 40 MG, QD | U | 0 | 40 | MG | TABLET | QD | |||||
| 90529194 | 9052919 | 4 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 20 MG, QD | 440 | MG | U | 0 | 20 | MG | TABLET | QD | |||
| 90529194 | 9052919 | 5 | C | ALDACTONE A | SPIRONOLACTONE | 1 | Oral | 25 MG, QD | U | 0 | 25 | MG | TABLET | QD | |||||
| 90529194 | 9052919 | 6 | C | SELBEX | TEPRENONE | 1 | Oral | 50 MG, TID | U | 0 | 50 | MG | CAPSULE | TID | |||||
| 90529194 | 9052919 | 7 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 90529194 | 9052919 | 1 | Pulmonary arterial hypertension |
| 90529194 | 9052919 | 2 | Product used for unknown indication |
| 90529194 | 9052919 | 3 | Pulmonary arterial hypertension |
| 90529194 | 9052919 | 4 | Pulmonary arterial hypertension |
| 90529194 | 9052919 | 5 | Pulmonary arterial hypertension |
| 90529194 | 9052919 | 6 | Prophylaxis against gastrointestinal ulcer |
| 90529194 | 9052919 | 7 | Prophylaxis against gastrointestinal ulcer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 90529194 | 9052919 | OT |
| 90529194 | 9052919 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 90529194 | 9052919 | Hypoacusis | |
| 90529194 | 9052919 | Nasal congestion | |
| 90529194 | 9052919 | Otitis media | |
| 90529194 | 9052919 | Pain in jaw |
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 |
|---|---|---|---|---|---|---|
| 90529194 | 9052919 | 1 | 20121126 | 0 | ||
| 90529194 | 9052919 | 2 | 20121207 | 0 | ||
| 90529194 | 9052919 | 3 | 20121213 | 0 | ||
| 90529194 | 9052919 | 4 | 20121213 | 20130121 | 0 | |
| 90529194 | 9052919 | 5 | 20121213 | 0 | ||
| 90529194 | 9052919 | 6 | 20121215 | 0 | ||
| 90529194 | 9052919 | 7 | 20121208 | 0 |