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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126471071 | 12647107 | 1 | I | 20150509 | 20150513 | 20160812 | 20160812 | EXP | BR-ROCHE-1580439 | ROCHE | 85.21 | YR | F | Y | 59.70000 | KG | 20160812 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126471071 | 12647107 | 1 | PS | Tocilizumab | TOCILIZUMAB | 1 | Subcutaneous | DATE OF LAST DOSE PRIOR TO SAE 06/MAY/2015 | Y | 1146374 | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 126471071 | 12647107 | 2 | SS | Tocilizumab | TOCILIZUMAB | 1 | Subcutaneous | Y | 1146374 | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 126471071 | 12647107 | 3 | SS | Tocilizumab | TOCILIZUMAB | 1 | Subcutaneous | Y | 1146374 | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 126471071 | 12647107 | 4 | SS | Tocilizumab | TOCILIZUMAB | 1 | Subcutaneous | Y | 1146374 | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 126471071 | 12647107 | 5 | SS | Tocilizumab | TOCILIZUMAB | 1 | Subcutaneous | Y | 1146374 | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 126471071 | 12647107 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 2 TABLET ONCE A DAY | 0 | TABLET | QD | ||||||||
| 126471071 | 12647107 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 40 | MG | QD | ||||||||
| 126471071 | 12647107 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 20 | MG | QD | ||||||||
| 126471071 | 12647107 | 9 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 126471071 | 12647107 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | QD | ||||||||||
| 126471071 | 12647107 | 11 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | QD | ||||||||||
| 126471071 | 12647107 | 12 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 20 | MG | |||||||||
| 126471071 | 12647107 | 13 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | |||||||||||
| 126471071 | 12647107 | 14 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 750 | MG | BID | ||||||||
| 126471071 | 12647107 | 15 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | BIW | ||||||||||
| 126471071 | 12647107 | 16 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | /wk | ||||||||||
| 126471071 | 12647107 | 17 | C | LORATADINE. | LORATADINE | 1 | Oral | 0 | 10 | MG | BID | ||||||||
| 126471071 | 12647107 | 18 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | TABLET | QD | |||||||
| 126471071 | 12647107 | 19 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 126471071 | 12647107 | 20 | C | LACTULONA | 2 | Unknown | 0 | 10 | ML | QD | |||||||||
| 126471071 | 12647107 | 21 | C | LACTULONA | 2 | Unknown | 1 OTHER | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126471071 | 12647107 | 1 | Rheumatoid arthritis |
| 126471071 | 12647107 | 6 | Rheumatoid arthritis |
| 126471071 | 12647107 | 14 | Rheumatoid arthritis |
| 126471071 | 12647107 | 15 | Rheumatoid arthritis |
| 126471071 | 12647107 | 16 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126471071 | 12647107 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126471071 | 12647107 | Deep vein thrombosis | |
| 126471071 | 12647107 | Interstitial lung disease | |
| 126471071 | 12647107 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 126471071 | 12647107 | 1 | 20150323 | 20150706 | 0 | |
| 126471071 | 12647107 | 2 | 20150413 | 0 | ||
| 126471071 | 12647107 | 3 | 20150422 | 0 | ||
| 126471071 | 12647107 | 4 | 20150429 | 0 | ||
| 126471071 | 12647107 | 5 | 20150504 | 20150511 | 0 | |
| 126471071 | 12647107 | 6 | 20150509 | 0 | ||
| 126471071 | 12647107 | 7 | 20150603 | 20150706 | 0 | |
| 126471071 | 12647107 | 8 | 20150707 | 0 | ||
| 126471071 | 12647107 | 9 | 20150526 | 0 | ||
| 126471071 | 12647107 | 11 | 201411 | 20150602 | 0 | |
| 126471071 | 12647107 | 12 | 20150603 | 0 | ||
| 126471071 | 12647107 | 13 | 20150526 | 0 | ||
| 126471071 | 12647107 | 14 | 201410 | 0 | ||
| 126471071 | 12647107 | 15 | 2010 | 20150511 | 0 | |
| 126471071 | 12647107 | 16 | 2010 | 20150511 | 0 | |
| 126471071 | 12647107 | 17 | 20150427 | 20150810 | 0 | |
| 126471071 | 12647107 | 18 | 20150603 | 0 | ||
| 126471071 | 12647107 | 19 | 20150525 | 0 | ||
| 126471071 | 12647107 | 20 | 20150603 | 20150810 | 0 | |
| 126471071 | 12647107 | 21 | 20150526 | 0 |