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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123788354 | 12378835 | 4 | F | 20160627 | 20160517 | 20160708 | EXP | US-ACTELION-A-NJ2016-131719 | ACTELION | 59.00 | YR | A | F | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123788354 | 12378835 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP019P0101,OP021P0101,OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 123788354 | 12378835 | 2 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 123788354 | 12378835 | 3 | C | TYVASO | TREPROSTINIL | 1 | U | 0 | |||||||||||
| 123788354 | 12378835 | 4 | C | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | U | 0 | |||||||||||
| 123788354 | 12378835 | 5 | C | DILTIAZEM. | DILTIAZEM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123788354 | 12378835 | 1 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123788354 | 12378835 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123788354 | 12378835 | Diarrhoea | |
| 123788354 | 12378835 | Dyspnoea | |
| 123788354 | 12378835 | Influenza like illness | |
| 123788354 | 12378835 | Lower respiratory tract congestion | |
| 123788354 | 12378835 | Lung infection | |
| 123788354 | 12378835 | Pneumothorax spontaneous | |
| 123788354 | 12378835 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 123788354 | 12378835 | 1 | 20081105 | 0 |