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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124751232 | 12475123 | 2 | F | 20151124 | 20160627 | 20160617 | 20160701 | EXP | AU-ROCHE-1668063 | ROCHE | 50.85 | YR | F | Y | 0.00000 | 20160701 | MD | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124751232 | 12475123 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE ADMINISTERED PRIOR TO SAE ON 13/NOV/2015 | 103705 | 686 | MG | SOLUTION FOR INFUSION | /wk | ||||||
| 124751232 | 12475123 | 2 | SS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 686 | MG | SOLUTION FOR INFUSION | /wk | |||||||
| 124751232 | 12475123 | 3 | SS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 686 | MG | SOLUTION FOR INFUSION | /wk | |||||||
| 124751232 | 12475123 | 4 | SS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 686 | MG | SOLUTION FOR INFUSION | /wk | |||||||
| 124751232 | 12475123 | 5 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | DATE OF LAST TREATMENT PRIOR TO SAE : 05/JUN/2016 | U | 0 | |||||||||
| 124751232 | 12475123 | 6 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 20 | MG | QD | ||||||||
| 124751232 | 12475123 | 7 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 50 | MG | |||||||||
| 124751232 | 12475123 | 8 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 10 | MG | |||||||||
| 124751232 | 12475123 | 9 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 5 | MG | |||||||||
| 124751232 | 12475123 | 10 | C | SULFAMETHOXAZOLE/TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | DOSE: 800MG/160MG | 0 | TIW | |||||||||
| 124751232 | 12475123 | 11 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 40 | MG | QD | ||||||||
| 124751232 | 12475123 | 12 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 124751232 | 12475123 | 13 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 0 | 20 | MG | QD | ||||||||
| 124751232 | 12475123 | 14 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 0 | 20 | MG | |||||||||
| 124751232 | 12475123 | 15 | C | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 0 | 60 | MG | QD | ||||||||
| 124751232 | 12475123 | 16 | C | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 0 | 60 | MG | QD | ||||||||
| 124751232 | 12475123 | 17 | C | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 0 | 30 | MG | |||||||||
| 124751232 | 12475123 | 18 | C | FAMCICLOVIR. | FAMCICLOVIR | 1 | Oral | 0 | |||||||||||
| 124751232 | 12475123 | 19 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 0 | 50 | MG | |||||||||
| 124751232 | 12475123 | 20 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 0 | 50 | MG | QD | ||||||||
| 124751232 | 12475123 | 21 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | 0 | 25 | MG | |||||||||
| 124751232 | 12475123 | 22 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | 0 | 600 | MG | QD | ||||||||
| 124751232 | 12475123 | 23 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Oral | 0 | 25 | UG | QD | ||||||||
| 124751232 | 12475123 | 24 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Unknown | 0 | 12.5 | UG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124751232 | 12475123 | 1 | Anti-neutrophil cytoplasmic antibody positive vasculitis |
| 124751232 | 12475123 | 5 | Anti-neutrophil cytoplasmic antibody positive vasculitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124751232 | 12475123 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124751232 | 12475123 | Acute kidney injury | |
| 124751232 | 12475123 | Escherichia bacteraemia | |
| 124751232 | 12475123 | Escherichia urinary tract infection | |
| 124751232 | 12475123 | Pyelonephritis |
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 |
|---|---|---|---|---|---|---|
| 124751232 | 12475123 | 1 | 20151023 | 0 | ||
| 124751232 | 12475123 | 2 | 20151030 | 0 | ||
| 124751232 | 12475123 | 3 | 20151106 | 0 | ||
| 124751232 | 12475123 | 4 | 20151113 | 0 | ||
| 124751232 | 12475123 | 5 | 20160229 | 0 | ||
| 124751232 | 12475123 | 6 | 20151120 | 20151125 | 0 | |
| 124751232 | 12475123 | 7 | 20151128 | 0 | ||
| 124751232 | 12475123 | 8 | 20160127 | 0 | ||
| 124751232 | 12475123 | 9 | 20160325 | 0 | ||
| 124751232 | 12475123 | 10 | 20151125 | 0 | ||
| 124751232 | 12475123 | 11 | 2013 | 0 | ||
| 124751232 | 12475123 | 12 | 20131016 | 0 | ||
| 124751232 | 12475123 | 13 | 20131104 | 0 | ||
| 124751232 | 12475123 | 14 | 20131029 | 0 | ||
| 124751232 | 12475123 | 15 | 20151126 | 0 | ||
| 124751232 | 12475123 | 17 | 20151207 | 0 | ||
| 124751232 | 12475123 | 18 | 20151207 | 20151213 | 0 | |
| 124751232 | 12475123 | 20 | 20150208 | 0 | ||
| 124751232 | 12475123 | 21 | 20160108 | 0 | ||
| 124751232 | 12475123 | 22 | 20151216 | 0 | ||
| 124751232 | 12475123 | 24 | 20151216 | 0 |