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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113953209 | 11395320 | 9 | F | 20160901 | 20150819 | 20160913 | EXP | US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2015-120739 | ACTELION | 65.00 | YR | E | F | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113953209 | 11395320 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP054P0101,IP055P0101;EP105P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 113953209 | 11395320 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP021P0101,OP023P010,OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 113953209 | 11395320 | 3 | SS | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113953209 | 11395320 | 4 | SS | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | Oral | UNK | 0 | ||||||||||
| 113953209 | 11395320 | 5 | C | REMODULIN | TREPROSTINIL | 1 | U | 0 | |||||||||||
| 113953209 | 11395320 | 6 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 113953209 | 11395320 | 7 | C | OXYGEN. | OXYGEN | 1 | 4 L/MIN AT NIGHT | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113953209 | 11395320 | 1 | Pulmonary arterial hypertension |
| 113953209 | 11395320 | 3 | Product used for unknown indication |
| 113953209 | 11395320 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113953209 | 11395320 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113953209 | 11395320 | Condition aggravated | |
| 113953209 | 11395320 | Diarrhoea | |
| 113953209 | 11395320 | Dizziness | |
| 113953209 | 11395320 | Dyspnoea | |
| 113953209 | 11395320 | Erythema | |
| 113953209 | 11395320 | Flushing | |
| 113953209 | 11395320 | Headache | |
| 113953209 | 11395320 | Influenza like illness | |
| 113953209 | 11395320 | Lymphadenopathy | |
| 113953209 | 11395320 | Nasopharyngitis | |
| 113953209 | 11395320 | Nausea | |
| 113953209 | 11395320 | Oxygen saturation decreased | |
| 113953209 | 11395320 | Peripheral swelling | |
| 113953209 | 11395320 | Pulmonary arterial pressure increased | |
| 113953209 | 11395320 | Scleroderma | |
| 113953209 | 11395320 | Skin lesion | |
| 113953209 | 11395320 | Tinnitus | |
| 113953209 | 11395320 | Viral infection | |
| 113953209 | 11395320 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 113953209 | 11395320 | 1 | 20130806 | 0 | ||
| 113953209 | 11395320 | 3 | 201602 | 0 |