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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103940606 | 10394060 | 6 | F | 2014 | 20160727 | 20140819 | 20160804 | PER | US-ACTELION-A-NJ2014-102330 | ACTELION | 56.00 | YR | A | M | Y | 44.45000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103940606 | 10394060 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | HP015P0101, EP099P0101, NP010A0101 | 21290 | 62.5 | MG | TABLET | BID | |||||
| 103940606 | 10394060 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 103940606 | 10394060 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 2.00 NG/KG, CONT INFUS | 0 | ||||||||||
| 103940606 | 10394060 | 4 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 103940606 | 10394060 | 5 | C | FAMODITINE | 2 | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||||
| 103940606 | 10394060 | 6 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG, BID | U | 0 | 40 | MG | BID | ||||||
| 103940606 | 10394060 | 7 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 25 MG, QD | U | 0 | 25 | MG | QD | ||||||
| 103940606 | 10394060 | 8 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | 25 MG, QD | U | 0 | 25 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103940606 | 10394060 | 1 | Pulmonary arterial hypertension |
| 103940606 | 10394060 | 3 | Cor pulmonale chronic |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103940606 | 10394060 | Abdominal pain lower | |
| 103940606 | 10394060 | Abdominal pain upper | |
| 103940606 | 10394060 | Erythema | |
| 103940606 | 10394060 | Fall | |
| 103940606 | 10394060 | Feeling abnormal | |
| 103940606 | 10394060 | Headache | |
| 103940606 | 10394060 | Infusion site bruising | |
| 103940606 | 10394060 | Infusion site erythema | |
| 103940606 | 10394060 | Infusion site infection | |
| 103940606 | 10394060 | Infusion site nodule | |
| 103940606 | 10394060 | Infusion site pain | |
| 103940606 | 10394060 | Infusion site swelling | |
| 103940606 | 10394060 | Limb injury | |
| 103940606 | 10394060 | Malaise | |
| 103940606 | 10394060 | Oedema | |
| 103940606 | 10394060 | Pain in extremity | |
| 103940606 | 10394060 | Palpitations | |
| 103940606 | 10394060 | Peripheral swelling | |
| 103940606 | 10394060 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 103940606 | 10394060 | 1 | 20140606 | 0 | ||
| 103940606 | 10394060 | 3 | 20140621 | 0 |