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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118496893 | 11849689 | 3 | F | 20150414 | 20160906 | 20151218 | 20160909 | EXP | US-BAYER-2015-022170 | BAYER | 53.00 | YR | A | F | Y | 67.57000 | KG | 20160909 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118496893 | 11849689 | 1 | PS | ADEMPAS | RIOCIGUAT | 1 | Oral | UNK UNK, TID | BXGU872 | 204819 | |||||||||
| 118496893 | 11849689 | 2 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXGZ9P2 | 204819 | 2.5 | MG | TID | ||||||
| 118496893 | 11849689 | 3 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 5 MG, TID | BXGZ9P2 | 204819 | 5 | MG | TID | ||||||
| 118496893 | 11849689 | 4 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH3JN1 | 204819 | 2.5 | MG | TID | ||||||
| 118496893 | 11849689 | 5 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH43C2 | 204819 | 2.5 | MG | TID | ||||||
| 118496893 | 11849689 | 6 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH7CK4 | 204819 | 2.5 | MG | TID | ||||||
| 118496893 | 11849689 | 7 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH8FC2 | 204819 | 2.5 | MG | TID | ||||||
| 118496893 | 11849689 | 8 | SS | REMODULIN | TREPROSTINIL | 1 | 0 | ||||||||||||
| 118496893 | 11849689 | 9 | C | LETAIRIS | AMBRISENTAN | 1 | 5 MG, UNK | 0 | 5 | MG | |||||||||
| 118496893 | 11849689 | 10 | C | ARIXTRA | FONDAPARINUX SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118496893 | 11849689 | 1 | Pulmonary arterial hypertension |
| 118496893 | 11849689 | 2 | Pulmonary arterial hypertension |
| 118496893 | 11849689 | 3 | Pulmonary arterial hypertension |
| 118496893 | 11849689 | 4 | Pulmonary arterial hypertension |
| 118496893 | 11849689 | 5 | Pulmonary arterial hypertension |
| 118496893 | 11849689 | 6 | Pulmonary arterial hypertension |
| 118496893 | 11849689 | 7 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118496893 | 11849689 | HO |
| 118496893 | 11849689 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118496893 | 11849689 | Accidental overdose | |
| 118496893 | 11849689 | Aphasia | |
| 118496893 | 11849689 | Application site erythema | |
| 118496893 | 11849689 | Application site warmth | |
| 118496893 | 11849689 | Catheter site pain | |
| 118496893 | 11849689 | Deep vein thrombosis | |
| 118496893 | 11849689 | Dehydration | |
| 118496893 | 11849689 | Depressed mood | |
| 118496893 | 11849689 | Diarrhoea | |
| 118496893 | 11849689 | Dizziness | |
| 118496893 | 11849689 | Drug dose omission | |
| 118496893 | 11849689 | Dyspnoea | |
| 118496893 | 11849689 | Ecchymosis | |
| 118496893 | 11849689 | Feeling abnormal | |
| 118496893 | 11849689 | Haematoma | |
| 118496893 | 11849689 | Heart rate increased | |
| 118496893 | 11849689 | Hospitalisation | |
| 118496893 | 11849689 | Hypertension | |
| 118496893 | 11849689 | Injection site haemorrhage | |
| 118496893 | 11849689 | Nausea | |
| 118496893 | 11849689 | Oedema peripheral | |
| 118496893 | 11849689 | Pain | |
| 118496893 | 11849689 | Pain in extremity | |
| 118496893 | 11849689 | Palpitations | |
| 118496893 | 11849689 | Peripheral swelling | |
| 118496893 | 11849689 | Swelling | |
| 118496893 | 11849689 | Tachycardia | |
| 118496893 | 11849689 | 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 |
|---|---|---|---|---|---|---|
| 118496893 | 11849689 | 1 | 20140115 | 0 | ||
| 118496893 | 11849689 | 3 | 20150608 | 0 |