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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125548042 | 12554804 | 2 | F | 20160707 | 20160713 | 20160714 | EXP | DE-ACTELION-A-US2016-139285 | ACTELION | 34.00 | DY | I | Y | 0.00000 | 20160714 | OT | DE | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125548042 | 12554804 | 1 | PS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 80 MCG, QD | 21779 | 80 | UG | INHALATION VAPOUR, SOLUTION | QD | ||||||
| 125548042 | 12554804 | 2 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 120 MCG, QD | 21779 | 120 | UG | INHALATION VAPOUR, SOLUTION | QD | ||||||
| 125548042 | 12554804 | 3 | C | TRACLEER | BOSENTAN | 1 | Oral | U | 21290 | TABLET | |||||||||
| 125548042 | 12554804 | 4 | C | EPOPROSTENOL. | EPOPROSTENOL | 1 | U | 0 | |||||||||||
| 125548042 | 12554804 | 5 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 125548042 | 12554804 | 6 | C | BOSMIN | EPINEPHRINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125548042 | 12554804 | 1 | Persistent foetal circulation |
| 125548042 | 12554804 | 3 | Persistent foetal circulation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125548042 | 12554804 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125548042 | 12554804 | Drug administered to patient of inappropriate age | |
| 125548042 | 12554804 | Pulmonary hypertension |
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 |
|---|---|---|---|---|---|---|
| 125548042 | 12554804 | 1 | 20160609 | 20160612 | 0 | |
| 125548042 | 12554804 | 2 | 20160613 | 20160616 | 0 |