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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126274251 | 12627425 | 1 | I | 20160801 | 20160805 | 20160805 | EXP | NO-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-50569BI | BOEHRINGER INGELHEIM | WYLLER V,JACOBSEN K,DAHL M,NILSEN H,PROSKE S,HORTER T,E. INTERFERON GAMMA MAY IMPROVE CARDIAC FUNCTION IN FRIEDREICH^S ATAXIA CARDIOMYOPATHY. INTERNATIONAL JOURNAL OF CARDIOLOGY 2016;221:376-378. | 18.00 | YR | F | Y | 0.00000 | 20160805 | OT | COUNTRY NOT SPECIFIED | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126274251 | 12627425 | 1 | SS | IMUKIN | INTERFERON GAMMA | 1 | Subcutaneous | FORMULATION: INJECTION, DOSAGES WERE GRADUALLY INCREASED FROM 10 MCG UP TO 100 MCG OVER TWO MONTHS; | U | 0 | TIW | ||||||||
| 126274251 | 12627425 | 2 | PS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Unknown | U | 20520 | ||||||||||
| 126274251 | 12627425 | 3 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 0 | |||||||||||
| 126274251 | 12627425 | 4 | C | DISOPYRAMIDE | DISOPYRAMIDE | 1 | Unknown | 0 | |||||||||||
| 126274251 | 12627425 | 5 | C | IVABRADINE | IVABRADINE | 1 | Unknown | 0 | |||||||||||
| 126274251 | 12627425 | 6 | C | IBEDENONE | 2 | Unknown | 0 | ||||||||||||
| 126274251 | 12627425 | 7 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 126274251 | 12627425 | 8 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126274251 | 12627425 | 1 | Cardiomyopathy |
| 126274251 | 12627425 | 2 | Product used for unknown indication |
| 126274251 | 12627425 | 3 | Product used for unknown indication |
| 126274251 | 12627425 | 4 | Product used for unknown indication |
| 126274251 | 12627425 | 5 | Product used for unknown indication |
| 126274251 | 12627425 | 6 | Product used for unknown indication |
| 126274251 | 12627425 | 7 | Product used for unknown indication |
| 126274251 | 12627425 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126274251 | 12627425 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126274251 | 12627425 | Chest pain | |
| 126274251 | 12627425 | Dehydration | |
| 126274251 | 12627425 | Malaise | |
| 126274251 | 12627425 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 126274251 | 12627425 | 1 | 201410 | 0 |