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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126963162 | 12696316 | 2 | F | 201411 | 20160913 | 20160830 | 20160915 | EXP | CA-ROCHE-1492145 | ROCHE | 63.56 | YR | M | Y | 58.00000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126963162 | 12696316 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | FREQUENCY: DAY 1 AND DAY 15, PREVIOUS RITUXAN INFUSION: 08/APR/2013?DOSE WAS CHANGED FROM 1000 MG T | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 126963162 | 12696316 | 2 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | U | 50722 | ||||||||||
| 126963162 | 12696316 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | N | 0 | ||||||||||
| 126963162 | 12696316 | 4 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126963162 | 12696316 | 5 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 126963162 | 12696316 | 6 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 126963162 | 12696316 | 7 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 126963162 | 12696316 | 8 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126963162 | 12696316 | 1 | Pemphigoid |
| 126963162 | 12696316 | 2 | Product used for unknown indication |
| 126963162 | 12696316 | 3 | Product used for unknown indication |
| 126963162 | 12696316 | 6 | Premedication |
| 126963162 | 12696316 | 7 | Premedication |
| 126963162 | 12696316 | 8 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126963162 | 12696316 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126963162 | 12696316 | Blood pressure systolic abnormal | |
| 126963162 | 12696316 | Diabetes mellitus | |
| 126963162 | 12696316 | Hepatic enzyme increased | |
| 126963162 | 12696316 | Infusion related reaction | |
| 126963162 | 12696316 | Mood altered | |
| 126963162 | 12696316 | Osteoporosis | |
| 126963162 | 12696316 | Pemphigus | |
| 126963162 | 12696316 | 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 |
|---|---|---|---|---|---|---|
| 126963162 | 12696316 | 1 | 20090126 | 0 | ||
| 126963162 | 12696316 | 2 | 2001 | 0 | ||
| 126963162 | 12696316 | 3 | 2001 | 0 | ||
| 126963162 | 12696316 | 6 | 20090126 | 0 | ||
| 126963162 | 12696316 | 7 | 20090126 | 0 | ||
| 126963162 | 12696316 | 8 | 20090126 | 0 |