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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127005382 | 12700538 | 2 | F | 20160818 | 20160828 | 20160830 | 20160909 | EXP | US-ACTELION-A-US2016-134859 | ACTELION | 71.00 | YR | E | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127005382 | 12700538 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 32 NG/KG, PER MIN | MM081M0101, MM088M0101 | 22260 | INJECTION | /min | |||||||
| 127005382 | 12700538 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 21290 | 125 | MG | TABLET | BID | ||||||
| 127005382 | 12700538 | 3 | C | PREDNISONE. | PREDNISONE | 1 | 16 MG, UNK | Y | 0 | 16 | MG | ||||||||
| 127005382 | 12700538 | 4 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 5 | C | ELIQUIS | APIXABAN | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 7 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 8 | C | CIPRODEX | CIPROFLOXACIN HYDROCHLORIDEDEXAMETHASONE | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 9 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 10 | C | ONDASETRON | ONDANSETRON | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 11 | C | FENTANYL. | FENTANYL | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 12 | C | ACTONEL | RISEDRONATE SODIUM | 1 | U | 0 | |||||||||||
| 127005382 | 12700538 | 13 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127005382 | 12700538 | 1 | Pulmonary hypertension |
| 127005382 | 12700538 | 2 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127005382 | 12700538 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127005382 | 12700538 | Diarrhoea | |
| 127005382 | 12700538 | Dyspnoea | |
| 127005382 | 12700538 | Fluid overload | |
| 127005382 | 12700538 | Fluid retention | |
| 127005382 | 12700538 | Infection | |
| 127005382 | 12700538 | Oedema | |
| 127005382 | 12700538 | Oxygen consumption increased |
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 |
|---|---|---|---|---|---|---|
| 127005382 | 12700538 | 1 | 20140226 | 0 | ||
| 127005382 | 12700538 | 2 | 20120724 | 0 |