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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125692551 | 12569255 | 1 | I | 20130129 | 20130129 | 20160719 | 20160719 | EXP | CA-ROCHE-1186444 | ROCHE | 16.27 | YR | M | Y | 46.00000 | KG | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125692551 | 12569255 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | THERAPY DELAYED | U | 125276 | 368 | MG | SOLUTION FOR INFUSION | ||||||
| 125692551 | 12569255 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125276 | 184 | MG | SOLUTION FOR INFUSION | |||||||
| 125692551 | 12569255 | 3 | SS | NAPROSYN | NAPROXEN | 1 | Unknown | U | 17581 | 500 | MG | ||||||||
| 125692551 | 12569255 | 4 | SS | NAPROSYN | NAPROXEN | 1 | Unknown | U | 17581 | 375 | MG | ||||||||
| 125692551 | 12569255 | 5 | C | EURO-FOLIC | 2 | Unknown | 0 | 5 | MG | ||||||||||
| 125692551 | 12569255 | 6 | C | LOSEC | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 125692551 | 12569255 | 7 | C | FRISIUM | CLOBAZAM | 1 | Unknown | 0 | 10 | MG | |||||||||
| 125692551 | 12569255 | 8 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 125692551 | 12569255 | 9 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 0 | ||||||||||||
| 125692551 | 12569255 | 10 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 125692551 | 12569255 | 11 | C | HYPERTONIC SALINE | SODIUM CHLORIDE | 1 | 0 | ||||||||||||
| 125692551 | 12569255 | 12 | C | ALVESCO | CICLESONIDE | 1 | 0 | ||||||||||||
| 125692551 | 12569255 | 13 | C | XOLAIR | OMALIZUMAB | 1 | Unknown | 1FS/MS | 0 | ||||||||||
| 125692551 | 12569255 | 14 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125692551 | 12569255 | 1 | Juvenile idiopathic arthritis |
| 125692551 | 12569255 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125692551 | 12569255 | OT |
| 125692551 | 12569255 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125692551 | 12569255 | Bacterial infection | |
| 125692551 | 12569255 | Blood cortisol decreased | |
| 125692551 | 12569255 | Body temperature increased | |
| 125692551 | 12569255 | Bronchitis | |
| 125692551 | 12569255 | Corneal disorder | |
| 125692551 | 12569255 | Cough | |
| 125692551 | 12569255 | Hepatic enzyme increased | |
| 125692551 | 12569255 | Hypotension | |
| 125692551 | 12569255 | Immunosuppression | |
| 125692551 | 12569255 | Insomnia | |
| 125692551 | 12569255 | Lung infection | |
| 125692551 | 12569255 | Lung infection pseudomonal | |
| 125692551 | 12569255 | Malaise | |
| 125692551 | 12569255 | Nasopharyngitis | |
| 125692551 | 12569255 | Pneumonia | |
| 125692551 | 12569255 | Post procedural haematoma | |
| 125692551 | 12569255 | Respiratory tract infection | |
| 125692551 | 12569255 | Septic shock | |
| 125692551 | 12569255 | Sputum discoloured | |
| 125692551 | 12569255 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 125692551 | 12569255 | 1 | 20130110 | 0 | ||
| 125692551 | 12569255 | 2 | 20150901 | 0 |