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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121537103 | 12153710 | 3 | F | 201207 | 20160901 | 20160307 | 20160905 | EXP | CA-ROCHE-1128855 | ROCHE | 30.50 | YR | F | Y | 49.00000 | KG | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121537103 | 12153710 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE ON 08/JAN/2013. | B20051,B20071,B20131,B20172,B20152, | 125276 | 344 | MG | SOLUTION FOR INFUSION | ||||||
| 121537103 | 12153710 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20051,B20071,B20131,B20172,B20152, | 125276 | 344 | MG | SOLUTION FOR INFUSION | |||||||
| 121537103 | 12153710 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20051,B20071,B20131,B20172,B20152, | 125276 | 364 | MG | SOLUTION FOR INFUSION | |||||||
| 121537103 | 12153710 | 4 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20051,B20071,B20131,B20172,B20152, | 125276 | 328 | MG | SOLUTION FOR INFUSION | |||||||
| 121537103 | 12153710 | 5 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20051,B20071,B20131,B20172,B20152, | 125276 | 344 | MG | SOLUTION FOR INFUSION | |||||||
| 121537103 | 12153710 | 6 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20051,B20071,B20131,B20172,B20152, | 125276 | 344 | MG | SOLUTION FOR INFUSION | |||||||
| 121537103 | 12153710 | 7 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20051,B20071,B20131,B20172,B20152, | 125276 | 400 | MG | SOLUTION FOR INFUSION | |||||||
| 121537103 | 12153710 | 8 | C | SULFASALAZINE. | SULFASALAZINE | 1 | 0 | ||||||||||||
| 121537103 | 12153710 | 9 | C | NASONEX | MOMETASONE FUROATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121537103 | 12153710 | 1 | Juvenile idiopathic arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121537103 | 12153710 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121537103 | 12153710 | Blood pressure diastolic increased | |
| 121537103 | 12153710 | Blood pressure increased | |
| 121537103 | 12153710 | Body temperature decreased | |
| 121537103 | 12153710 | Contusion | |
| 121537103 | 12153710 | Cough | |
| 121537103 | 12153710 | Dermatitis | |
| 121537103 | 12153710 | Eczema | |
| 121537103 | 12153710 | Erythema | |
| 121537103 | 12153710 | Fatigue | |
| 121537103 | 12153710 | Feeling hot | |
| 121537103 | 12153710 | Gingival pain | |
| 121537103 | 12153710 | Gingivitis | |
| 121537103 | 12153710 | Headache | |
| 121537103 | 12153710 | Heart rate increased | |
| 121537103 | 12153710 | Influenza like illness | |
| 121537103 | 12153710 | Infusion related reaction | |
| 121537103 | 12153710 | Insomnia | |
| 121537103 | 12153710 | Menorrhagia | |
| 121537103 | 12153710 | Menstruation irregular | |
| 121537103 | 12153710 | Nasopharyngitis | |
| 121537103 | 12153710 | Nausea | |
| 121537103 | 12153710 | Oral herpes | |
| 121537103 | 12153710 | Oxygen saturation decreased | |
| 121537103 | 12153710 | Pain | |
| 121537103 | 12153710 | Photophobia | |
| 121537103 | 12153710 | Pruritus | |
| 121537103 | 12153710 | Skin papilloma | |
| 121537103 | 12153710 | Stress | |
| 121537103 | 12153710 | Weight decreased | |
| 121537103 | 12153710 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 121537103 | 12153710 | 1 | 20120518 | 0 | ||
| 121537103 | 12153710 | 2 | 20120618 | 0 | ||
| 121537103 | 12153710 | 3 | 20130408 | 0 | ||
| 121537103 | 12153710 | 4 | 20130507 | 0 | ||
| 121537103 | 12153710 | 5 | 20140422 | 0 | ||
| 121537103 | 12153710 | 6 | 20140819 | 0 | ||
| 121537103 | 12153710 | 7 | 20150406 | 0 |