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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1165169313 | 11651693 | 13 | F | 20150810 | 20160823 | 20151022 | 20160824 | EXP | CA-ROCHE-1648204 | ROCHE | 73.11 | YR | F | Y | 0.00000 | 20160824 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1165169313 | 11651693 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DATE OF MOST RECENT DOSE: 25/AUG/2015 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 1165169313 | 11651693 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 10 | MG | QD | |||||||
| 1165169313 | 11651693 | 3 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 1165169313 | 11651693 | 4 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 975 | MG | |||||||||
| 1165169313 | 11651693 | 5 | C | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | 0 | 1 | G | TABLET | QID | |||||||
| 1165169313 | 11651693 | 6 | C | SALOFALK | MESALAMINE | 1 | 0 | ||||||||||||
| 1165169313 | 11651693 | 7 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 1G 1 TANS TWICE PER DAY | 0 | 1 | G | BID | |||||||
| 1165169313 | 11651693 | 8 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1165169313 | 11651693 | 1 | Myositis |
| 1165169313 | 11651693 | 2 | Product used for unknown indication |
| 1165169313 | 11651693 | 3 | Premedication |
| 1165169313 | 11651693 | 4 | Premedication |
| 1165169313 | 11651693 | 8 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1165169313 | 11651693 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1165169313 | 11651693 | Abdominal pain | |
| 1165169313 | 11651693 | Anal incontinence | |
| 1165169313 | 11651693 | Asthenia | |
| 1165169313 | 11651693 | Back pain | |
| 1165169313 | 11651693 | Balance disorder | |
| 1165169313 | 11651693 | Bradycardia | |
| 1165169313 | 11651693 | Bronchitis | |
| 1165169313 | 11651693 | Diarrhoea | |
| 1165169313 | 11651693 | Genital disorder female | |
| 1165169313 | 11651693 | Headache | |
| 1165169313 | 11651693 | Ill-defined disorder | |
| 1165169313 | 11651693 | Influenza | |
| 1165169313 | 11651693 | Muscle spasms | |
| 1165169313 | 11651693 | Muscular weakness | |
| 1165169313 | 11651693 | Nausea | |
| 1165169313 | 11651693 | Off label use | |
| 1165169313 | 11651693 | Oropharyngeal pain | |
| 1165169313 | 11651693 | Productive cough | |
| 1165169313 | 11651693 | Pulmonary pain | |
| 1165169313 | 11651693 | Vaginal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 1165169313 | 11651693 | 1 | 20150810 | 0 | ||
| 1165169313 | 11651693 | 3 | 20150825 | 0 | ||
| 1165169313 | 11651693 | 4 | 20150825 | 0 | ||
| 1165169313 | 11651693 | 8 | 20150825 | 0 |