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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122940183 | 12294018 | 3 | F | 20151101 | 20160905 | 20160422 | 20160915 | EXP | BE-ACTELION-A-CH2016-134603 | ACTELION | 31.00 | YR | A | F | Y | 62.00000 | KG | 20160915 | OT | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122940183 | 12294018 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 6 NG/KG, PER MIN | MM062M0601, MM046M0101 | 22260 | INJECTION | /min | |||||||
| 122940183 | 12294018 | 2 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 2 NG/KG, PER MIN | 22260 | INJECTION | /min | ||||||||
| 122940183 | 12294018 | 3 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 15 NG/KG, PER MIN | 22260 | INJECTION | /min | ||||||||
| 122940183 | 12294018 | 4 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 6.5 NG/KG, PER MIN | 22260 | INJECTION | /min | ||||||||
| 122940183 | 12294018 | 5 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | 21290 | 62.5 | MG | TABLET | BID | ||||||
| 122940183 | 12294018 | 6 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 21290 | 125 | MG | TABLET | BID | ||||||
| 122940183 | 12294018 | 7 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 122940183 | 12294018 | 8 | C | LANOXIN | DIGOXIN | 1 | Oral | 0.125 MG, QD | U | 0 | .125 | MG | QD | ||||||
| 122940183 | 12294018 | 9 | C | LOSFERRON | 2 | Oral | UNK, QD | U | 0 | QD | |||||||||
| 122940183 | 12294018 | 10 | C | NEXIAM | ESOMEPRAZOLE | 1 | Oral | 20 UNK, BID | U | 0 | BID | ||||||||
| 122940183 | 12294018 | 11 | C | SINTROM | ACENOCOUMAROL | 1 | Oral | 3.0 MG, QD | U | 0 | 3 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122940183 | 12294018 | 1 | Pulmonary arterial hypertension |
| 122940183 | 12294018 | 5 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122940183 | 12294018 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122940183 | 12294018 | Abdominal distension | |
| 122940183 | 12294018 | Chest discomfort | |
| 122940183 | 12294018 | Decreased appetite | |
| 122940183 | 12294018 | Depressed mood | |
| 122940183 | 12294018 | Flushing | |
| 122940183 | 12294018 | Malaise | |
| 122940183 | 12294018 | Pallor | |
| 122940183 | 12294018 | Palpitations | |
| 122940183 | 12294018 | Product reconstitution issue | |
| 122940183 | 12294018 | Sensation of foreign body |
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 |
|---|---|---|---|---|---|---|
| 122940183 | 12294018 | 2 | 20150622 | 0 | ||
| 122940183 | 12294018 | 5 | 201103 | 201103 | 0 | |
| 122940183 | 12294018 | 6 | 201104 | 0 |