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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117997022 | 11799702 | 2 | F | 2012 | 20160817 | 20151203 | 20160829 | PER | US-ACTELION-A-US2015-128012 | ACTELION | 50.00 | YR | A | F | Y | 98.87000 | KG | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117997022 | 11799702 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | UNK | Y | 21290 | TABLET | ||||||||
| 117997022 | 11799702 | 2 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 117997022 | 11799702 | 3 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | 20 MG, BID | 0 | 20 | MG | BID | |||||||
| 117997022 | 11799702 | 4 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 5 MG, QD | Y | U | 0 | 5 | MG | QD | |||||
| 117997022 | 11799702 | 5 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 500 MG, BID | U | 0 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117997022 | 11799702 | 1 | Pulmonary hypertension |
| 117997022 | 11799702 | 2 | Pulmonary hypertension |
| 117997022 | 11799702 | 4 | Pulmonary hypertension |
| 117997022 | 11799702 | 5 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117997022 | 11799702 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117997022 | 11799702 | Chest pain | |
| 117997022 | 11799702 | Dyspnoea | |
| 117997022 | 11799702 | General physical health deterioration | |
| 117997022 | 11799702 | Hallucination | |
| 117997022 | 11799702 | Headache | |
| 117997022 | 11799702 | Hepatic failure | |
| 117997022 | 11799702 | Malaise | |
| 117997022 | 11799702 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 117997022 | 11799702 | 1 | 2011 | 2012 | 0 | |
| 117997022 | 11799702 | 2 | 2009 | 0 | ||
| 117997022 | 11799702 | 3 | 2013 | 0 | ||
| 117997022 | 11799702 | 4 | 2012 | 0 |