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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113293164 | 11329316 | 4 | F | 20141125 | 20160907 | 20150803 | 20160909 | EXP | CA-ROCHE-1615812 | ROCHE | 34.00 | YR | M | Y | 73.00000 | KG | 20160909 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113293164 | 11329316 | 1 | PS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | THERAPY DURATION: 78 DAYS | U | 103964 | 180 | UG | |||||||
| 113293164 | 11329316 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | THERAPY DURATION: 84 DAYS | U | 21511 | 1000 | MG | |||||||
| 113293164 | 11329316 | 3 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | THERAPY DURATON: 84 DAYS | U | 0 | 400 | MG | TABLET | ||||||
| 113293164 | 11329316 | 4 | SS | ZOPLICONE | ZOPICLONE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113293164 | 11329316 | 1 | Hepatitis C |
| 113293164 | 11329316 | 2 | Hepatitis C |
| 113293164 | 11329316 | 3 | Hepatitis C |
| 113293164 | 11329316 | 4 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113293164 | 11329316 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113293164 | 11329316 | Affect lability | |
| 113293164 | 11329316 | Anger | |
| 113293164 | 11329316 | Anxiety | |
| 113293164 | 11329316 | Arthralgia | |
| 113293164 | 11329316 | Bedridden | |
| 113293164 | 11329316 | Decreased appetite | |
| 113293164 | 11329316 | Depressed mood | |
| 113293164 | 11329316 | Depression | |
| 113293164 | 11329316 | Dry mouth | |
| 113293164 | 11329316 | Fatigue | |
| 113293164 | 11329316 | Feeling abnormal | |
| 113293164 | 11329316 | Influenza like illness | |
| 113293164 | 11329316 | Insomnia | |
| 113293164 | 11329316 | Irritability | |
| 113293164 | 11329316 | Malaise | |
| 113293164 | 11329316 | Myalgia | |
| 113293164 | 11329316 | Pain | |
| 113293164 | 11329316 | Pruritus | |
| 113293164 | 11329316 | Thinking abnormal | |
| 113293164 | 11329316 | 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 |
|---|---|---|---|---|---|---|
| 113293164 | 11329316 | 1 | 20141010 | 20141226 | 0 | |
| 113293164 | 11329316 | 2 | 20141011 | 20150102 | 0 | |
| 113293164 | 11329316 | 3 | 20141011 | 20150102 | 0 |