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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 860285610 | 8602856 | 10 | F | 20120315 | 20160914 | 20120607 | 20160920 | EXP | JP-ROCHE-1073639 | ROCHE | 66.43 | YR | M | Y | 60.80000 | KG | 20160920 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 860285610 | 8602856 | 1 | PS | Tocilizumab | TOCILIZUMAB | 1 | Subcutaneous | Y | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||
| 860285610 | 8602856 | 2 | SS | Tocilizumab | TOCILIZUMAB | 1 | Subcutaneous | Y | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||
| 860285610 | 8602856 | 3 | SS | MOHRUS TAPE | KETOPROFEN | 1 | Topical | SINGLE USE | 0 | ||||||||||
| 860285610 | 8602856 | 4 | SS | TANATRIL | IMIDAPRIL | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 860285610 | 8602856 | 5 | SS | LANDEL | UNSPECIFIED INGREDIENT | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 860285610 | 8602856 | 6 | SS | OLMETEC | OLMESARTAN MEDOXOMIL | 1 | Oral | 0 | 30 | MG | TABLET | QD | |||||||
| 860285610 | 8602856 | 7 | SS | ADALAT CC | NIFEDIPINE | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 860285610 | 8602856 | 8 | SS | CYTOTEC | MISOPROSTOL | 1 | Oral | Y | 0 | 100 | UG | TABLET | QD | ||||||
| 860285610 | 8602856 | 9 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Subcutaneous | D | 0 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||||
| 860285610 | 8602856 | 10 | SS | Tocilizumab | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | D | 125276 | 8 | MG/KG | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 860285610 | 8602856 | 1 | Rheumatoid arthritis |
| 860285610 | 8602856 | 3 | Rheumatoid arthritis |
| 860285610 | 8602856 | 4 | Hypertension |
| 860285610 | 8602856 | 5 | Hypertension |
| 860285610 | 8602856 | 6 | Hypertension |
| 860285610 | 8602856 | 7 | Hypertension |
| 860285610 | 8602856 | 8 | Gastritis prophylaxis |
| 860285610 | 8602856 | 9 | Rheumatoid arthritis |
| 860285610 | 8602856 | 10 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 860285610 | 8602856 | LT |
| 860285610 | 8602856 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 860285610 | 8602856 | Agranulocytosis | |
| 860285610 | 8602856 | Pneumonia | |
| 860285610 | 8602856 | Septic shock |
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 |
|---|---|---|---|---|---|---|
| 860285610 | 8602856 | 1 | 20110304 | 0 | ||
| 860285610 | 8602856 | 2 | 20120223 | 20120223 | 0 | |
| 860285610 | 8602856 | 3 | 20030704 | 0 | ||
| 860285610 | 8602856 | 4 | 2004 | 0 | ||
| 860285610 | 8602856 | 5 | 2004 | 0 | ||
| 860285610 | 8602856 | 6 | 20090306 | 0 | ||
| 860285610 | 8602856 | 7 | 20101001 | 0 | ||
| 860285610 | 8602856 | 8 | 20120322 | 20120525 | 0 | |
| 860285610 | 8602856 | 9 | 20100917 | 0 | ||
| 860285610 | 8602856 | 10 | 20100917 | 0 |