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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123418928 | 12341892 | 8 | F | 20160421 | 20160826 | 20160506 | 20160908 | PER | US-ACTELION-A-NJ2016-135355 | ACTELION | 63.00 | YR | A | F | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123418928 | 12341892 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM016A0201,UM019A0101 | 204410 | 10 | MG | TABLET | QD | |||||
| 123418928 | 12341892 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.069 UG/KG | U | U | 0 | ||||||||
| 123418928 | 12341892 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | 0.069 UG/KG | U | U | 0 | ||||||||
| 123418928 | 12341892 | 4 | SS | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 123418928 | 12341892 | 5 | C | ADCIRCA | TADALAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123418928 | 12341892 | 1 | Pulmonary hypertension |
| 123418928 | 12341892 | 2 | Pulmonary hypertension |
| 123418928 | 12341892 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123418928 | 12341892 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123418928 | 12341892 | Back disorder | |
| 123418928 | 12341892 | Catheter site pain | |
| 123418928 | 12341892 | Diarrhoea | |
| 123418928 | 12341892 | Dizziness | |
| 123418928 | 12341892 | Dyspnoea | |
| 123418928 | 12341892 | Erythema | |
| 123418928 | 12341892 | Extra dose administered | |
| 123418928 | 12341892 | Fatigue | |
| 123418928 | 12341892 | Headache | |
| 123418928 | 12341892 | Infusion site infection | |
| 123418928 | 12341892 | Nausea | |
| 123418928 | 12341892 | Skin infection |
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 |
|---|---|---|---|---|---|---|
| 123418928 | 12341892 | 1 | 20160324 | 0 | ||
| 123418928 | 12341892 | 2 | 20091208 | 0 | ||
| 123418928 | 12341892 | 3 | 2016 | 0 |