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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 936345616 | 9363456 | 16 | F | 20121220 | 20160725 | 20130624 | 20160729 | EXP | CA-ROCHE-1173428 | ROCHE | 53.47 | YR | F | Y | 93.90000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 936345616 | 9363456 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 19/JUN/2014 | B6223B012,B6242B012 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||
| 936345616 | 9363456 | 2 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 100 | MG | ||||||||
| 936345616 | 9363456 | 3 | SS | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | U | 0 | ||||||||||
| 936345616 | 9363456 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 936345616 | 9363456 | 5 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | 100 | MG | ||||||||
| 936345616 | 9363456 | 6 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG | ||||||||
| 936345616 | 9363456 | 7 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 8 | C | RALIVIA | TRAMADOL HYDROCHLORIDE | 1 | Unknown | TABLET - EXTENDED RELEASE | 0 | ||||||||||
| 936345616 | 9363456 | 9 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 10 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 11 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 12 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 13 | C | LEVEMIR | INSULIN DETEMIR | 1 | Subcutaneous | 0 | |||||||||||
| 936345616 | 9363456 | 14 | C | TRIATEC (RAMIPRIL) | RAMIPRIL | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 15 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Unknown | 50 MCG/MD | 0 | ||||||||||
| 936345616 | 9363456 | 16 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 936345616 | 9363456 | 17 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 18 | C | BISACODYL. | BISACODYL | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 19 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 20 | C | ATIVAN | LORAZEPAM | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 21 | C | HYDROMORPH CONTIN | HYDROMORPHONE | 1 | Unknown | 0 | |||||||||||
| 936345616 | 9363456 | 22 | C | ASPIRIN. | ASPIRIN | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 23 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 24 | C | LYRICA | PREGABALIN | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 25 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 26 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 936345616 | 9363456 | 27 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 0 | 650 | MG | |||||||||
| 936345616 | 9363456 | 28 | C | INSULIN | INSULIN NOS | 1 | Unknown | 4 U | 0 | ||||||||||
| 936345616 | 9363456 | 29 | C | NOVORAPID | INSULIN ASPART | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 30 | C | LOSEC | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 936345616 | 9363456 | 31 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 936345616 | 9363456 | 1 | Rheumatoid arthritis |
| 936345616 | 9363456 | 2 | Premedication |
| 936345616 | 9363456 | 3 | Product used for unknown indication |
| 936345616 | 9363456 | 4 | Product used for unknown indication |
| 936345616 | 9363456 | 5 | Premedication |
| 936345616 | 9363456 | 25 | Blood pressure measurement |
| 936345616 | 9363456 | 26 | Premedication |
| 936345616 | 9363456 | 27 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 936345616 | 9363456 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 936345616 | 9363456 | Arthralgia | |
| 936345616 | 9363456 | Arthropathy | |
| 936345616 | 9363456 | Blood glucose increased | |
| 936345616 | 9363456 | Blood pressure fluctuation | |
| 936345616 | 9363456 | Blood pressure increased | |
| 936345616 | 9363456 | Cataract | |
| 936345616 | 9363456 | Drug effect decreased | |
| 936345616 | 9363456 | Lung infection | |
| 936345616 | 9363456 | Pain | |
| 936345616 | 9363456 | Vein disorder |
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 |
|---|---|---|---|---|---|---|
| 936345616 | 9363456 | 1 | 20110615 | 0 | ||
| 936345616 | 9363456 | 2 | 20110615 | 0 | ||
| 936345616 | 9363456 | 5 | 20110615 | 20130605 | 0 | |
| 936345616 | 9363456 | 6 | 20131118 | 0 | ||
| 936345616 | 9363456 | 26 | 20110615 | 20120731 | 0 | |
| 936345616 | 9363456 | 27 | 20110615 | 20121220 | 0 |