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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124694492 | 12469449 | 2 | F | 20160523 | 20160803 | 20160615 | 20160816 | EXP | US-ACTELION-A-NJ2016-137336 | ACTELION | 62.00 | YR | A | F | Y | 0.00000 | 20160816 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124694492 | 12469449 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP023P0101;OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 124694492 | 12469449 | 2 | C | REVATIO | SILDENAFIL CITRATE | 1 | 100 MG, TID | U | 0 | 100 | MG | TID | |||||||
| 124694492 | 12469449 | 3 | C | REMODULIN | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | 16 NG/KG, PER MIN | U | 0 | /min | ||||||||
| 124694492 | 12469449 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | UNK | Y | U | 0 | |||||||||
| 124694492 | 12469449 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 50 MCG, QD | U | 0 | 50 | UG | QD | |||||||
| 124694492 | 12469449 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | 1200 MG, TID | U | 0 | 1200 | MG | TID | |||||||
| 124694492 | 12469449 | 7 | C | NORTRIPTYLINE | NORTRIPTYLINE | 1 | 25 MG, QD | U | 0 | 25 | MG | QD | |||||||
| 124694492 | 12469449 | 8 | C | OXYCODONE | OXYCODONE | 1 | 5 MG, PRN | U | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124694492 | 12469449 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124694492 | 12469449 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124694492 | 12469449 | Cough | |
| 124694492 | 12469449 | Gastrointestinal haemorrhage | |
| 124694492 | 12469449 | International normalised ratio increased | |
| 124694492 | 12469449 | Pneumonia | |
| 124694492 | 12469449 | Pyrexia | |
| 124694492 | 12469449 | Respiratory failure | |
| 124694492 | 12469449 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 124694492 | 12469449 | 1 | 20141212 | 0 | ||
| 124694492 | 12469449 | 2 | 20090724 | 0 | ||
| 124694492 | 12469449 | 3 | 20160715 | 0 | ||
| 124694492 | 12469449 | 4 | 20060511 | 20160606 | 0 | |
| 124694492 | 12469449 | 6 | 20111123 | 0 | ||
| 124694492 | 12469449 | 7 | 20150225 | 0 | ||
| 124694492 | 12469449 | 8 | 20110909 | 0 |