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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125829432 | 12582943 | 2 | F | 2015 | 20160817 | 20160722 | 20160826 | EXP | US-BAYER-2015-416450 | BAYER | 62.00 | YR | A | F | Y | 77.98000 | KG | 20160826 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125829432 | 12582943 | 1 | PS | ADEMPAS | RIOCIGUAT | 1 | UNK | 204819 | |||||||||||
| 125829432 | 12582943 | 2 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 1 MG, TID | BXH0L11 | 204819 | 1 | MG | TID | ||||||
| 125829432 | 12582943 | 3 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 1.5 MG, TID | BXH4K41 | 204819 | 1.5 | MG | TID | ||||||
| 125829432 | 12582943 | 4 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2 MG, TID | BXGU9V1 | 204819 | 2 | MG | TID | ||||||
| 125829432 | 12582943 | 5 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH6H51 | 204819 | 2.5 | MG | TID | ||||||
| 125829432 | 12582943 | 6 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH7CK2 | 204819 | 2.5 | MG | TID | ||||||
| 125829432 | 12582943 | 7 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH7CK2 | 204819 | 2.5 | MG | TID | ||||||
| 125829432 | 12582943 | 8 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH3JN1 | 204819 | 2.5 | MG | TID | ||||||
| 125829432 | 12582943 | 9 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH7CK3 | 204819 | 2.5 | MG | TID | ||||||
| 125829432 | 12582943 | 10 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH7CK4 | 204819 | 2.5 | MG | TID | ||||||
| 125829432 | 12582943 | 11 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | BXH8FC1 | 204819 | 2.5 | MG | TID | ||||||
| 125829432 | 12582943 | 12 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 95 NG/KG/MIN | 2100582 | 0 | |||||||||
| 125829432 | 12582943 | 13 | C | TRACLEER | BOSENTAN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125829432 | 12582943 | 1 | Pulmonary hypertension |
| 125829432 | 12582943 | 2 | Pulmonary hypertension |
| 125829432 | 12582943 | 3 | Pulmonary hypertension |
| 125829432 | 12582943 | 4 | Pulmonary hypertension |
| 125829432 | 12582943 | 5 | Pulmonary hypertension |
| 125829432 | 12582943 | 6 | Pulmonary hypertension |
| 125829432 | 12582943 | 7 | Pulmonary hypertension |
| 125829432 | 12582943 | 8 | Pulmonary hypertension |
| 125829432 | 12582943 | 9 | Pulmonary hypertension |
| 125829432 | 12582943 | 10 | Pulmonary hypertension |
| 125829432 | 12582943 | 11 | Pulmonary hypertension |
| 125829432 | 12582943 | 12 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125829432 | 12582943 | HO |
| 125829432 | 12582943 | OT |
| 125829432 | 12582943 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125829432 | 12582943 | Abdominal discomfort | |
| 125829432 | 12582943 | Abnormal loss of weight | |
| 125829432 | 12582943 | Adverse drug reaction | |
| 125829432 | 12582943 | Blood pressure increased | |
| 125829432 | 12582943 | Cardiac discomfort | |
| 125829432 | 12582943 | Chest discomfort | |
| 125829432 | 12582943 | Cholecystitis acute | |
| 125829432 | 12582943 | Cholecystostomy | |
| 125829432 | 12582943 | Clostridium difficile colitis | |
| 125829432 | 12582943 | Depressed mood | |
| 125829432 | 12582943 | Diarrhoea | |
| 125829432 | 12582943 | Dyspnoea | |
| 125829432 | 12582943 | Ear discomfort | |
| 125829432 | 12582943 | Flushing | |
| 125829432 | 12582943 | Gallbladder disorder | |
| 125829432 | 12582943 | Gallbladder pain | |
| 125829432 | 12582943 | Gastrointestinal disorder | |
| 125829432 | 12582943 | General physical health deterioration | |
| 125829432 | 12582943 | Headache | |
| 125829432 | 12582943 | Hospitalisation | |
| 125829432 | 12582943 | Hypotension | |
| 125829432 | 12582943 | Infusion site infection | |
| 125829432 | 12582943 | Infusion site pain | |
| 125829432 | 12582943 | Infusion site reaction | |
| 125829432 | 12582943 | Infusion site urticaria | |
| 125829432 | 12582943 | Malaise | |
| 125829432 | 12582943 | Nausea | |
| 125829432 | 12582943 | Pain | |
| 125829432 | 12582943 | Pneumonia | |
| 125829432 | 12582943 | Pulmonary arterial hypertension | |
| 125829432 | 12582943 | Septic shock | |
| 125829432 | 12582943 | Syncope | |
| 125829432 | 12582943 | Urticaria | |
| 125829432 | 12582943 | Vision blurred | |
| 125829432 | 12582943 | Vomiting | |
| 125829432 | 12582943 | 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 |
|---|---|---|---|---|---|---|
| 125829432 | 12582943 | 1 | 20150723 | 0 | ||
| 125829432 | 12582943 | 12 | 20071018 | 0 |