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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126696582 | 12669658 | 2 | F | 20160204 | 20160825 | 20160819 | 20160906 | EXP | DE-BAYER-2016-026753 | BAYER | 19.00 | YR | A | F | Y | 53.00000 | KG | 20160906 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126696582 | 12669658 | 1 | PS | ADEMPAS | RIOCIGUAT | 1 | Oral | UNK UNK, | Y | 204819 | TABLET | ||||||||
| 126696582 | 12669658 | 2 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | Y | 204819 | 2.5 | MG | TABLET | TID | |||||
| 126696582 | 12669658 | 3 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 1 MG, TID | Y | 204819 | 1 | MG | TABLET | TID | |||||
| 126696582 | 12669658 | 4 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | Y | 204819 | 2.5 | MG | TABLET | TID | |||||
| 126696582 | 12669658 | 5 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 75 MG, ONCE | Y | 204819 | 75 | MG | TABLET | 1X | |||||
| 126696582 | 12669658 | 6 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | Y | 204819 | 2.5 | MG | TABLET | TID | |||||
| 126696582 | 12669658 | 7 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | Y | 204819 | 2.5 | MG | TABLET | TID | |||||
| 126696582 | 12669658 | 8 | SS | OPSUMIT | MACITENTAN | 1 | DAILY DOSE 10 MG | 0 | 10 | MG | QD | ||||||||
| 126696582 | 12669658 | 9 | SS | OPSUMIT | MACITENTAN | 1 | Oral | 100 MG, ONCE | 0 | 100 | MG | 1X | |||||||
| 126696582 | 12669658 | 10 | SS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | DAILY DOSE 10 MG | 0 | 10 | MG | |||||||||
| 126696582 | 12669658 | 11 | SS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | DAILY DOSE 5 MG | 0 | 5 | MG | |||||||||
| 126696582 | 12669658 | 12 | SS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 100 MG, ONCE | 0 | 100 | MG | 1X | ||||||||
| 126696582 | 12669658 | 13 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 126696582 | 12669658 | 14 | C | TADALAFIL | TADALAFIL | 1 | DAILY DOSE 20 MG | 0 | 20 | MG | |||||||||
| 126696582 | 12669658 | 15 | C | AMBRISENTAN | AMBRISENTAN | 1 | DAILY DOSE 5 MG | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126696582 | 12669658 | 1 | Pulmonary arterial hypertension |
| 126696582 | 12669658 | 2 | Pulmonary arterial hypertension |
| 126696582 | 12669658 | 3 | Pulmonary arterial hypertension |
| 126696582 | 12669658 | 4 | Pulmonary arterial hypertension |
| 126696582 | 12669658 | 5 | Pulmonary arterial hypertension |
| 126696582 | 12669658 | 6 | Pulmonary arterial hypertension |
| 126696582 | 12669658 | 7 | Pulmonary arterial hypertension |
| 126696582 | 12669658 | 13 | Anticoagulant therapy |
| 126696582 | 12669658 | 14 | Pulmonary arterial hypertension |
| 126696582 | 12669658 | 15 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126696582 | 12669658 | HO |
| 126696582 | 12669658 | LT |
| 126696582 | 12669658 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126696582 | 12669658 | Dizziness | |
| 126696582 | 12669658 | Fatigue | |
| 126696582 | 12669658 | Feeling hot | |
| 126696582 | 12669658 | Intentional overdose | |
| 126696582 | 12669658 | Loss of consciousness | |
| 126696582 | 12669658 | Suicide attempt | |
| 126696582 | 12669658 | Syncope | |
| 126696582 | 12669658 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 126696582 | 12669658 | 1 | 20140830 | 0 | ||
| 126696582 | 12669658 | 3 | 20150824 | 0 | ||
| 126696582 | 12669658 | 4 | 20160203 | 0 | ||
| 126696582 | 12669658 | 5 | 20160204 | 20160204 | 0 | |
| 126696582 | 12669658 | 6 | 20160209 | 201607 | 0 | |
| 126696582 | 12669658 | 7 | 20160209 | 201607 | 0 | |
| 126696582 | 12669658 | 9 | 20160204 | 20160204 | 0 | |
| 126696582 | 12669658 | 10 | 20140828 | 0 | ||
| 126696582 | 12669658 | 11 | 20150822 | 0 | ||
| 126696582 | 12669658 | 12 | 20160204 | 20160204 | 0 | |
| 126696582 | 12669658 | 13 | 20150722 | 0 | ||
| 126696582 | 12669658 | 14 | 20160809 | 0 | ||
| 126696582 | 12669658 | 15 | 20160808 | 0 |