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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125916891 | 12591689 | 1 | I | 20160327 | 0 | 20160725 | 20160725 | DIR | 54.00 | YR | M | N | 57.20000 | KG | 20160720 | N | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125916891 | 12591689 | 2 | PS | DACLATASVIR 60 MG BRISTOL-MYERS SQUIBB | DACLATASVIR | 1 | Oral | D | D | 0 | QD | ||||||||
| 125916891 | 12591689 | 3 | SS | SOFOSBUVIR 400 MG GILEAD SCIENCES, INC. | SOFOSBUVIR | 1 | Oral | D | D | 0 | QD | ||||||||
| 125916891 | 12591689 | 4 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | RIBAVIRIN 200MG ALTERNATING 400MG QD PO | D | D | 0 | 200 | MG | QD | |||||
| 125916891 | 12591689 | 5 | C | LANTUS | INSULIN GLARGINE | 1 | 0 | ||||||||||||
| 125916891 | 12591689 | 6 | C | INSULIN ASPART (NOVOLOG) | 2 | 0 | |||||||||||||
| 125916891 | 12591689 | 7 | C | NEURONTIN | GABAPENTIN | 1 | 0 | ||||||||||||
| 125916891 | 12591689 | 8 | C | METOPROLOL (LOPRESSOR) | 2 | 0 | |||||||||||||
| 125916891 | 12591689 | 9 | C | REMERON | MIRTAZAPINE | 1 | 0 | ||||||||||||
| 125916891 | 12591689 | 10 | C | PANTOPRAZOLE (PROTONIX) | 2 | 0 | |||||||||||||
| 125916891 | 12591689 | 11 | C | DELTASONE | PREDNISONE | 1 | 0 | ||||||||||||
| 125916891 | 12591689 | 12 | C | SILDENAFIL (VIAGRA) | 2 | 0 | |||||||||||||
| 125916891 | 12591689 | 13 | C | TACROLIMUS (PROGRAF) | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125916891 | 12591689 | 2 | Hepatitis C |
| 125916891 | 12591689 | 3 | Hepatitis C |
| 125916891 | 12591689 | 4 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125916891 | 12591689 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125916891 | 12591689 | Arthralgia | |
| 125916891 | 12591689 | Chest discomfort | |
| 125916891 | 12591689 | Depression | |
| 125916891 | 12591689 | Diabetic ketoacidosis | |
| 125916891 | 12591689 | Diarrhoea | |
| 125916891 | 12591689 | Dizziness | |
| 125916891 | 12591689 | Nausea | |
| 125916891 | 12591689 | Suicidal ideation | |
| 125916891 | 12591689 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 125916891 | 12591689 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125916891 | 12591689 | 2 | 20160301 | 0 | ||
| 125916891 | 12591689 | 3 | 20160301 | 0 | ||
| 125916891 | 12591689 | 4 | 20160301 | 0 |