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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96040688 | 9604068 | 8 | F | 2012 | 20160926 | 20131008 | 20160928 | EXP | CA-ROCHE-1285264 | ROCHE | 51.77 | YR | F | Y | 57.60000 | KG | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96040688 | 9604068 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE: 04/DEC/2014 | N3756 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||
| 96040688 | 9604068 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 96040688 | 9604068 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Oral | U | 0 | ||||||||||
| 96040688 | 9604068 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 96040688 | 9604068 | 5 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 96040688 | 9604068 | 6 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | |||||||||
| 96040688 | 9604068 | 7 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 96040688 | 9604068 | 8 | C | ADALAT | NIFEDIPINE | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 9 | C | WARFARIN | WARFARIN | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 10 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 11 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 96040688 | 9604068 | 12 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 13 | C | SULFATRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 14 | C | FOSAMAX | ALENDRONATE SODIUM | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 15 | C | BUTRANS | BUPRENORPHINE | 1 | Transdermal | PATCH, 10 MG/HR | 0 | ||||||||||
| 96040688 | 9604068 | 16 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 17 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 40 | MG | |||||||||
| 96040688 | 9604068 | 18 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 30 | MG | |||||||||
| 96040688 | 9604068 | 19 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 96040688 | 9604068 | 20 | C | RABEPRAZOLE | RABEPRAZOLE | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 21 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 96040688 | 9604068 | 22 | C | ESTROGEL | ESTRADIOL | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 96040688 | 9604068 | 1 | Mixed connective tissue disease |
| 96040688 | 9604068 | 2 | Product used for unknown indication |
| 96040688 | 9604068 | 4 | Product used for unknown indication |
| 96040688 | 9604068 | 5 | Premedication |
| 96040688 | 9604068 | 6 | Premedication |
| 96040688 | 9604068 | 17 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 96040688 | 9604068 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 96040688 | 9604068 | Arthralgia | |
| 96040688 | 9604068 | Balance disorder | |
| 96040688 | 9604068 | Basal cell carcinoma | |
| 96040688 | 9604068 | Bladder cancer | |
| 96040688 | 9604068 | Central nervous system lesion | |
| 96040688 | 9604068 | Cystitis | |
| 96040688 | 9604068 | Dizziness | |
| 96040688 | 9604068 | Dyspnoea | |
| 96040688 | 9604068 | Fatigue | |
| 96040688 | 9604068 | Gastrooesophageal reflux disease | |
| 96040688 | 9604068 | Hot flush | |
| 96040688 | 9604068 | Hypotension | |
| 96040688 | 9604068 | Infection | |
| 96040688 | 9604068 | Multiple sclerosis | |
| 96040688 | 9604068 | Muscle spasms | |
| 96040688 | 9604068 | Muscular weakness | |
| 96040688 | 9604068 | Neuralgia | |
| 96040688 | 9604068 | Pain | |
| 96040688 | 9604068 | Progressive multifocal leukoencephalopathy | |
| 96040688 | 9604068 | Respiratory symptom | |
| 96040688 | 9604068 | Skin tightness | |
| 96040688 | 9604068 | 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 |
|---|---|---|---|---|---|---|
| 96040688 | 9604068 | 1 | 20111221 | 0 | ||
| 96040688 | 9604068 | 2 | 201107 | 0 | ||
| 96040688 | 9604068 | 3 | 2009 | 0 | ||
| 96040688 | 9604068 | 5 | 20111221 | 0 | ||
| 96040688 | 9604068 | 6 | 20111221 | 0 | ||
| 96040688 | 9604068 | 7 | 20111221 | 0 | ||
| 96040688 | 9604068 | 11 | 201602 | 0 | ||
| 96040688 | 9604068 | 17 | 20111221 | 20111221 | 0 | |
| 96040688 | 9604068 | 18 | 20120917 | 20120917 | 0 | |
| 96040688 | 9604068 | 19 | 20121001 | 0 | ||
| 96040688 | 9604068 | 22 | 201606 | 0 |