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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117881212 | 11788121 | 2 | F | 20160825 | 20151201 | 20160829 | EXP | CA-ROCHE-1667828 | ROCHE | 0.00 | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117881212 | 11788121 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | U | 50722 | ||||||||||
| 117881212 | 11788121 | 2 | SS | BELIMUMAB | BELIMUMAB | 1 | Unknown | U | 0 | 810 | MG | ||||||||
| 117881212 | 11788121 | 3 | SS | BELIMUMAB | BELIMUMAB | 1 | Unknown | U | 0 | 810 | MG | ||||||||
| 117881212 | 11788121 | 4 | SS | BELIMUMAB | BELIMUMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 820 | MG | ||||||||
| 117881212 | 11788121 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | ||||||||||
| 117881212 | 11788121 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 50 | MG | ||||||||
| 117881212 | 11788121 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 50 | MG | ||||||||
| 117881212 | 11788121 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 50 | MG | ||||||||
| 117881212 | 11788121 | 9 | C | GRAVOL | DIMENHYDRINATE | 1 | Unknown | 0 | |||||||||||
| 117881212 | 11788121 | 10 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 0 | 400 | MG | QD | ||||||||
| 117881212 | 11788121 | 11 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117881212 | 11788121 | 1 | Product used for unknown indication |
| 117881212 | 11788121 | 2 | Systemic lupus erythematosus |
| 117881212 | 11788121 | 5 | Product used for unknown indication |
| 117881212 | 11788121 | 6 | Product used for unknown indication |
| 117881212 | 11788121 | 9 | Product used for unknown indication |
| 117881212 | 11788121 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117881212 | 11788121 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117881212 | 11788121 | Activities of daily living impaired | |
| 117881212 | 11788121 | Arthralgia | |
| 117881212 | 11788121 | Arthritis | |
| 117881212 | 11788121 | Astigmatism | |
| 117881212 | 11788121 | Balance disorder | |
| 117881212 | 11788121 | Dizziness | |
| 117881212 | 11788121 | Fall | |
| 117881212 | 11788121 | Fatigue | |
| 117881212 | 11788121 | Feeling hot | |
| 117881212 | 11788121 | Head discomfort | |
| 117881212 | 11788121 | Headache | |
| 117881212 | 11788121 | Hot flush | |
| 117881212 | 11788121 | Hypersomnia | |
| 117881212 | 11788121 | Hypnotherapy | |
| 117881212 | 11788121 | Incorrect dose administered | |
| 117881212 | 11788121 | Insomnia | |
| 117881212 | 11788121 | Kidney infection | |
| 117881212 | 11788121 | Malaise | |
| 117881212 | 11788121 | Musculoskeletal pain | |
| 117881212 | 11788121 | Nasal congestion | |
| 117881212 | 11788121 | Nausea | |
| 117881212 | 11788121 | Neck pain | |
| 117881212 | 11788121 | Nephrolithiasis | |
| 117881212 | 11788121 | Oropharyngeal discomfort | |
| 117881212 | 11788121 | Pain | |
| 117881212 | 11788121 | Pruritus | |
| 117881212 | 11788121 | Raynaud's phenomenon | |
| 117881212 | 11788121 | Sepsis | |
| 117881212 | 11788121 | Sinusitis | |
| 117881212 | 11788121 | Sleep apnoea syndrome | |
| 117881212 | 11788121 | Stress | |
| 117881212 | 11788121 | Upper respiratory tract congestion | |
| 117881212 | 11788121 | Urinary tract infection | |
| 117881212 | 11788121 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |