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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122932373 | 12293237 | 3 | F | 20160914 | 20160421 | 20160926 | EXP | US-ACTELION-A-NJ2016-134793 | ACTELION | 59.00 | YR | A | F | Y | 0.00000 | 20160926 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122932373 | 12293237 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP021P0101,OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 122932373 | 12293237 | 2 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | U | 0 | |||||||||||
| 122932373 | 12293237 | 3 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122932373 | 12293237 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122932373 | 12293237 | HO |
| 122932373 | 12293237 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122932373 | 12293237 | Anaemia | |
| 122932373 | 12293237 | Anxiety | |
| 122932373 | 12293237 | Balance disorder | |
| 122932373 | 12293237 | Blood creatinine increased | |
| 122932373 | 12293237 | Blood urea increased | |
| 122932373 | 12293237 | Contusion | |
| 122932373 | 12293237 | Cyanosis | |
| 122932373 | 12293237 | Dizziness | |
| 122932373 | 12293237 | Fall | |
| 122932373 | 12293237 | Feeding disorder | |
| 122932373 | 12293237 | Haemorrhage | |
| 122932373 | 12293237 | Hypertension | |
| 122932373 | 12293237 | Hypotension | |
| 122932373 | 12293237 | Insomnia | |
| 122932373 | 12293237 | Limb injury | |
| 122932373 | 12293237 | Nausea | |
| 122932373 | 12293237 | Poor peripheral circulation | |
| 122932373 | 12293237 | Swelling | |
| 122932373 | 12293237 | Transfusion | |
| 122932373 | 12293237 | Vitamin B12 deficiency | |
| 122932373 | 12293237 | 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 |
|---|---|---|---|---|---|---|
| 122932373 | 12293237 | 1 | 20120725 | 0 |