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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125529972 | 12552997 | 2 | F | 20160315 | 20160815 | 20160713 | 20160825 | EXP | US-ACTELION-A-US2016-132112 | ACTELION | 65.00 | YR | E | F | Y | 0.00000 | 20160825 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125529972 | 12552997 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 21290 | 125 | MG | TABLET | BID | ||||||
| 125529972 | 12552997 | 2 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 3 | C | REMODULIN | TREPROSTINIL | 1 | 68 NG/KG, UNK | U | 0 | ||||||||||
| 125529972 | 12552997 | 4 | C | METOLAZONE. | METOLAZONE | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 5 | C | TRAMADOL. | TRAMADOL | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 6 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 7 | C | ENALAPRIL | ENALAPRIL | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 8 | C | DIGOXIN. | DIGOXIN | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 9 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 10 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 11 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 12 | C | FUROSEMIDE. | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 13 | C | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125529972 | 12552997 | 14 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125529972 | 12552997 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125529972 | 12552997 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125529972 | 12552997 | Administration site infection | |
| 125529972 | 12552997 | Catheter site erythema | |
| 125529972 | 12552997 | Catheter site infection | |
| 125529972 | 12552997 | Catheter site pain | |
| 125529972 | 12552997 | Catheter site swelling | |
| 125529972 | 12552997 | Catheter site warmth | |
| 125529972 | 12552997 | Fatigue | |
| 125529972 | 12552997 | Fluid retention | |
| 125529972 | 12552997 | Oedema |
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 |
|---|---|---|---|---|---|---|
| 125529972 | 12552997 | 1 | 2013 | 0 | ||
| 125529972 | 12552997 | 3 | 20151208 | 0 |