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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126654892 | 12665489 | 2 | F | 20150510 | 20160919 | 20160818 | 20160928 | EXP | US-ACTELION-A-US2015-116280 | ACTELION | 16.00 | YR | T | F | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126654892 | 12665489 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 31.25 MG, UNK | NP010A0101 | 21290 | 31.25 | MG | TABLET | ||||||
| 126654892 | 12665489 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | NP011A0101 | 21290 | 62.5 | MG | TABLET | BID | |||||
| 126654892 | 12665489 | 3 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 126654892 | 12665489 | 4 | C | CALCIFIT | 2 | U | 0 | ||||||||||||
| 126654892 | 12665489 | 5 | C | CALCIUM | CALCIUM | 1 | U | 0 | |||||||||||
| 126654892 | 12665489 | 6 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | U | 0 | |||||||||||
| 126654892 | 12665489 | 7 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126654892 | 12665489 | 8 | C | VASODIL | 2 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126654892 | 12665489 | 1 | Pulmonary hypertension |
| 126654892 | 12665489 | 3 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126654892 | 12665489 | OT |
| 126654892 | 12665489 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126654892 | 12665489 | Disease progression | |
| 126654892 | 12665489 | Dizziness | |
| 126654892 | 12665489 | Dyspnoea | |
| 126654892 | 12665489 | Ear infection | |
| 126654892 | 12665489 | Fatigue | |
| 126654892 | 12665489 | Intracranial mass | |
| 126654892 | 12665489 | Pain | |
| 126654892 | 12665489 | Syncope |
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 |
|---|---|---|---|---|---|---|
| 126654892 | 12665489 | 2 | 20040520 | 0 |