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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126271092 | 12627109 | 2 | F | 2016 | 20160805 | 20160805 | 20160811 | EXP | US-ACTELION-A-NJ2012-74345 | ACTELION | 80.00 | YR | E | M | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126271092 | 12627109 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | N | U | IP028P0103/IP030P0, OP021P0101 | 21290 | 125 | MG | TABLET | BID | |||
| 126271092 | 12627109 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | N | U | IP023P0102/IP026P0101/IP056P0101 | 21290 | 62.5 | MG | TABLET | BID | |||
| 126271092 | 12627109 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | N | U | 21290 | 125 | MG | TABLET | BID | ||||
| 126271092 | 12627109 | 4 | C | SILDENAFIL. | SILDENAFIL | 1 | 20 MG, TID | U | 0 | 20 | MG | TID | |||||||
| 126271092 | 12627109 | 5 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | U | 0 | |||||||||||
| 126271092 | 12627109 | 6 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 10 MG, QPM | U | 0 | 10 | MG | QD | |||||||
| 126271092 | 12627109 | 7 | C | SUVOREXANT. | SUVOREXANT | 1 | 10 MG, QPM | U | 0 | 10 | MG | QD | |||||||
| 126271092 | 12627109 | 8 | C | MIDODRINE | MIDODRINE | 1 | 2.5 MG, TID | U | 0 | 2.5 | MG | TID | |||||||
| 126271092 | 12627109 | 9 | C | COQ10 | UBIDECARENONE | 1 | 10 ML, QD | U | 0 | 10 | ML | QD | |||||||
| 126271092 | 12627109 | 10 | C | QUININE | QUININE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126271092 | 12627109 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126271092 | 12627109 | OT |
| 126271092 | 12627109 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126271092 | 12627109 | Abdominal discomfort | |
| 126271092 | 12627109 | Abdominal pain | |
| 126271092 | 12627109 | Alanine aminotransferase increased | |
| 126271092 | 12627109 | Aspartate aminotransferase increased | |
| 126271092 | 12627109 | Asthenia | |
| 126271092 | 12627109 | Blood alkaline phosphatase increased | |
| 126271092 | 12627109 | Blood bilirubin increased | |
| 126271092 | 12627109 | Brain cancer metastatic | |
| 126271092 | 12627109 | Confusional state | |
| 126271092 | 12627109 | Depressed mood | |
| 126271092 | 12627109 | Dizziness | |
| 126271092 | 12627109 | Dyspnoea | |
| 126271092 | 12627109 | Fall | |
| 126271092 | 12627109 | Fatigue | |
| 126271092 | 12627109 | Feeling abnormal | |
| 126271092 | 12627109 | Gait disturbance | |
| 126271092 | 12627109 | Liver disorder | |
| 126271092 | 12627109 | Liver function test increased | |
| 126271092 | 12627109 | Lung neoplasm malignant | |
| 126271092 | 12627109 | Malaise | |
| 126271092 | 12627109 | Metastases to liver | |
| 126271092 | 12627109 | Muscle spasms | |
| 126271092 | 12627109 | Normal pressure hydrocephalus | |
| 126271092 | 12627109 | Oesophagitis | |
| 126271092 | 12627109 | Presyncope | |
| 126271092 | 12627109 | Somnolence | |
| 126271092 | 12627109 | 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 |
|---|---|---|---|---|---|---|
| 126271092 | 12627109 | 1 | 20160611 | 0 | ||
| 126271092 | 12627109 | 2 | 20020515 | 0 | ||
| 126271092 | 12627109 | 3 | 20160613 | 0 |