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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1001058215 | 10010582 | 15 | F | 20140218 | 20150626 | 20140314 | 20150630 | EXP | DE-ROCHE-1354830 | ROCHE | 64.00 | YR | F | Y | 72.00000 | KG | 20150630 | N | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1001058215 | 10010582 | 1 | PS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | C1D1?DATE OF LAST DOSE PRIOR TO SAE: 17/FEB/2014.?PERMANENTLY DISCONTINUED. | D | 1116234 | 104405 | 1000 | MG | INFUSION | QD | ||||
| 1001058215 | 10010582 | 2 | SS | Bendamustine | BENDAMUSTINE | 1 | Intravenous (not otherwise specified) | ONLY DOSE PRIOR TO SAE. ?DOSE AND FREQUENCY AS PER PROTOCOL. | D | 1116234 | 0 | 70 | MG/M**2 | ||||||
| 1001058215 | 10010582 | 3 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Intravenous (not otherwise specified) | D | 0 | 100 | MG | ||||||||
| 1001058215 | 10010582 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Intravenous (not otherwise specified) | SINGLE DOSE | D | 0 | 100 | MG | |||||||
| 1001058215 | 10010582 | 5 | C | INTRATECT | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | D | 0 | ||||||||||
| 1001058215 | 10010582 | 6 | C | INTRATECT | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | D | 0 | 10 | G | /month | |||||||
| 1001058215 | 10010582 | 7 | C | ATACAND | CANDESARTAN CILEXETIL | 1 | Oral | D | 0 | 12.5 | MG | QD | |||||||
| 1001058215 | 10010582 | 8 | C | ATACAND | CANDESARTAN CILEXETIL | 1 | Unknown | D | 0 | 12.5 | MG | ||||||||
| 1001058215 | 10010582 | 9 | C | L-THYROXIN | LEVOTHYROXINE SODIUM | 1 | Oral | D | 0 | 150 | MG | QD | |||||||
| 1001058215 | 10010582 | 10 | C | L-THYROXIN | LEVOTHYROXINE SODIUM | 1 | Unknown | D | 0 | ||||||||||
| 1001058215 | 10010582 | 11 | C | DIHYDROTACHYSTEROL | DIHYDROTACHYSTEROL | 1 | Oral | 10 PEARLS, SINGLE DOSE | D | 0 | |||||||||
| 1001058215 | 10010582 | 12 | C | DIHYDROTACHYSTEROL | DIHYDROTACHYSTEROL | 1 | Unknown | D | 0 | ||||||||||
| 1001058215 | 10010582 | 13 | C | LOSFERRON | 2 | Oral | 2 EFFERVESCENT TABLET | D | 0 | TABLET | |||||||||
| 1001058215 | 10010582 | 14 | C | LOSFERRON | 2 | Unknown | 2 EFFERVESCENT TABLET | D | 0 | TABLET | |||||||||
| 1001058215 | 10010582 | 15 | C | RANITIDIN | RANITIDINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | D | 0 | 4 | MG | ||||||||
| 1001058215 | 10010582 | 16 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | D | 0 | 1000 | MG | ||||||||
| 1001058215 | 10010582 | 17 | C | FENISTIL (GERMANY) | 2 | Intravenous (not otherwise specified) | D | 0 | 4 | MG | |||||||||
| 1001058215 | 10010582 | 18 | C | FENISTIL (GERMANY) | 2 | Intravenous (not otherwise specified) | SINGLE DOSE | D | 0 | 4 | MG | ||||||||
| 1001058215 | 10010582 | 19 | C | ONDANSETRON | ONDANSETRON | 1 | Intravenous (not otherwise specified) | D | 0 | 8 | MG | ||||||||
| 1001058215 | 10010582 | 20 | C | Sulfamethoxazole/Trimethoprim | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | D | 0 | 960 | MG | TID | |||||||
| 1001058215 | 10010582 | 21 | C | E153 | 2 | Intravenous (not otherwise specified) | D | 0 | 1000 | ML | |||||||||
| 1001058215 | 10010582 | 22 | C | E153 | 2 | Intravenous (not otherwise specified) | SINGLE DOSE | D | 0 | 500 | ML | ||||||||
| 1001058215 | 10010582 | 23 | C | FASTURTEC | RASBURICASE | 1 | Intravenous (not otherwise specified) | D | 0 | 35.2 | MG | ||||||||
| 1001058215 | 10010582 | 24 | C | NEULASTA | PEGFILGRASTIM | 1 | Subcutaneous | D | 0 | 48 | IU | ||||||||
| 1001058215 | 10010582 | 25 | C | NEULASTA | PEGFILGRASTIM | 1 | Subcutaneous | D | 0 | 48 | IU | ||||||||
| 1001058215 | 10010582 | 26 | C | FERRITIN | FERRITIN | 1 | Oral | 2 EFFERVESCENT TABLET | D | 0 | BID | ||||||||
| 1001058215 | 10010582 | 27 | C | RANITIC | RANITIDINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | SINGLE DOSE | D | 0 | 8 | MG | |||||||
| 1001058215 | 10010582 | 28 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | D | 0 | ||||||||||
| 1001058215 | 10010582 | 29 | C | ACICLOVIR | ACYCLOVIR | 1 | Oral | D | 0 | ||||||||||
| 1001058215 | 10010582 | 30 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | D | 0 | ||||||||||
| 1001058215 | 10010582 | 31 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | D | 0 | ||||||||||
| 1001058215 | 10010582 | 32 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | Oral | D | 0 | 40 | MG | QD | |||||||
| 1001058215 | 10010582 | 33 | C | AMLODIPIN | AMLODIPINE BESYLATE | 1 | Oral | D | 0 | 10 | MG | BID | |||||||
| 1001058215 | 10010582 | 34 | C | ASPIRIN. | ASPIRIN | 1 | Oral | D | 0 | 100 | MG | BID | |||||||
| 1001058215 | 10010582 | 35 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | D | 0 | 20 | MG | QD | |||||||
| 1001058215 | 10010582 | 36 | C | PENTACARINAT | PENTAMIDINE ISETHIONATE | 1 | Nasal | SINGLE DOSE | D | 0 | 300 | MG | |||||||
| 1001058215 | 10010582 | 37 | C | VALSARTAN. | VALSARTAN | 1 | Oral | D | 0 | 320 | MG | QD | |||||||
| 1001058215 | 10010582 | 38 | C | COTRIM D.S. | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | D | 0 | 960 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1001058215 | 10010582 | 1 | Chronic lymphocytic leukaemia |
| 1001058215 | 10010582 | 2 | Chronic lymphocytic leukaemia |
| 1001058215 | 10010582 | 15 | Prophylaxis |
| 1001058215 | 10010582 | 16 | Prophylaxis |
| 1001058215 | 10010582 | 17 | Prophylaxis |
| 1001058215 | 10010582 | 23 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1001058215 | 10010582 | HO |
| 1001058215 | 10010582 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1001058215 | 10010582 | Leukopenia | |
| 1001058215 | 10010582 | Pancytopenia | |
| 1001058215 | 10010582 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 1001058215 | 10010582 | 1 | 20140120 | 20140218 | 0 | |
| 1001058215 | 10010582 | 2 | 20140120 | 0 | ||
| 1001058215 | 10010582 | 3 | 20140120 | 20140217 | 0 | |
| 1001058215 | 10010582 | 4 | 20140217 | 20140217 | 0 | |
| 1001058215 | 10010582 | 5 | 20110926 | 0 | ||
| 1001058215 | 10010582 | 6 | 20140108 | 20140313 | 0 | |
| 1001058215 | 10010582 | 7 | 20140108 | 20140313 | 0 | |
| 1001058215 | 10010582 | 8 | 20140218 | 0 | ||
| 1001058215 | 10010582 | 9 | 20140108 | 20140313 | 0 | |
| 1001058215 | 10010582 | 10 | 20140218 | 0 | ||
| 1001058215 | 10010582 | 11 | 20140108 | 20140313 | 0 | |
| 1001058215 | 10010582 | 12 | 20140218 | 0 | ||
| 1001058215 | 10010582 | 13 | 20140108 | 0 | ||
| 1001058215 | 10010582 | 14 | 20140218 | 0 | ||
| 1001058215 | 10010582 | 15 | 20140120 | 20140217 | 0 | |
| 1001058215 | 10010582 | 16 | 20140120 | 20140217 | 0 | |
| 1001058215 | 10010582 | 17 | 20140120 | 20140217 | 0 | |
| 1001058215 | 10010582 | 18 | 20140217 | 20140217 | 0 | |
| 1001058215 | 10010582 | 19 | 20140121 | 20140217 | 0 | |
| 1001058215 | 10010582 | 20 | 20140120 | 0 | ||
| 1001058215 | 10010582 | 21 | 20140120 | 20140217 | 0 | |
| 1001058215 | 10010582 | 22 | 20140217 | 20140217 | 0 | |
| 1001058215 | 10010582 | 23 | 20140120 | 20140217 | 0 | |
| 1001058215 | 10010582 | 24 | 20140123 | 20140123 | 0 | |
| 1001058215 | 10010582 | 25 | 20140131 | 20140131 | 0 | |
| 1001058215 | 10010582 | 26 | 20140108 | 20140313 | 0 | |
| 1001058215 | 10010582 | 27 | 20140217 | 20140217 | 0 | |
| 1001058215 | 10010582 | 28 | 20140122 | 20140213 | 0 | |
| 1001058215 | 10010582 | 29 | 20140122 | 0 | ||
| 1001058215 | 10010582 | 30 | 20140222 | 0 | ||
| 1001058215 | 10010582 | 31 | 20140122 | 20140203 | 0 | |
| 1001058215 | 10010582 | 32 | 20140203 | 20140313 | 0 | |
| 1001058215 | 10010582 | 33 | 20140203 | 20140227 | 0 | |
| 1001058215 | 10010582 | 34 | 20140203 | 0 | ||
| 1001058215 | 10010582 | 35 | 20140203 | 20140313 | 0 | |
| 1001058215 | 10010582 | 36 | 20140213 | 20140213 | 0 | |
| 1001058215 | 10010582 | 37 | 20140108 | 20140227 | 0 | |
| 1001058215 | 10010582 | 38 | 20140120 | 20140217 | 0 |