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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125820252 | 12582025 | 2 | F | 20160705 | 20160826 | 20160722 | 20160904 | EXP | FR-ROCHE-1791998 | ROCHE | 76.22 | YR | M | Y | 70.00000 | KG | 20160904 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125820252 | 12582025 | 1 | PS | Polatuzumab Vedotin | POLATUZUMAB VEDOTIN | 1 | Intravenous (not otherwise specified) | ON 01/JUL/2016, THE PATIENT RECEIVED THE MOST RECENT DOSE OF POLATUZUMAB VEDOTIN (126 MG) PRIOR TO O | 1149854 | 109409 | 126 | MG | INFUSION | ||||||
| 125820252 | 12582025 | 2 | SS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | DAYS 1, 8, AND 15 OF CYCLE 1 AND ON DAY 1 OF SUBSEQUENT CYCLES. ON 30/JUN/2016, THE PATIENT RECEIVED | Y | 1151639 | 125486 | 1000 | MG | SOLUTION FOR INFUSION | |||||
| 125820252 | 12582025 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | ON 02/JUL/2016, THE PATIENT RECEIVED THE MOST RECENT DOSE OF PREDNISONE (100 MG) PRIOR TO ONSET OF S | 1147133 | 0 | 100 | MG | |||||||
| 125820252 | 12582025 | 4 | SS | Doxorubicin | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | ON 30/JUN/2016, THE PATIENT RECEIVED THE MOST RECENT DOSE OF DOXORUBICIN (89 MG) PRIOR TO ONSET OF S | 1149875 | 0 | 89 | MG | INFUSION | ||||||
| 125820252 | 12582025 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | ON 30/JUN/2016, THE PATIENT RECEIVED THE MOST RECENT DOSE OF CYCLOPHOSPHAMIDE (1329 MG) PRIOR TO ONS | 1147239 | 0 | 1329 | MG | INFUSION | ||||||
| 125820252 | 12582025 | 6 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Oral | 0 | 1 | DF | |||||||||
| 125820252 | 12582025 | 7 | C | HEXTRIL | 2 | Oral | 0 | 1 | DF | ||||||||||
| 125820252 | 12582025 | 8 | C | FUNGIZONE | AMPHOTERICIN B | 1 | Oral | 0 | 1 | DF | |||||||||
| 125820252 | 12582025 | 9 | C | EUPANTOL | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 20 | MG | |||||||||
| 125820252 | 12582025 | 10 | C | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 0 | 4 | MG | |||||||||
| 125820252 | 12582025 | 11 | C | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | Intravenous (not otherwise specified) | 0 | 4 | MG | |||||||||
| 125820252 | 12582025 | 12 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 1 | G | |||||||||
| 125820252 | 12582025 | 13 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 40 | MG | |||||||||
| 125820252 | 12582025 | 14 | C | TRANXENE T-TAB | CLORAZEPATE DIPOTASSIUM | 1 | Oral | 0 | 10 | MG | |||||||||
| 125820252 | 12582025 | 15 | C | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | |||||||||
| 125820252 | 12582025 | 16 | C | FORLAX | POLYETHYLENE GLYCOL 4000 | 1 | Oral | 2 OTHER | 0 | ||||||||||
| 125820252 | 12582025 | 17 | C | LOPERAMIDE | LOPERAMIDE | 1 | Oral | ND | 0 | ||||||||||
| 125820252 | 12582025 | 18 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Intravenous (not otherwise specified) | ND | 0 | ||||||||||
| 125820252 | 12582025 | 19 | C | MOPRAL | OMEPRAZOLE SODIUM | 1 | Unknown | ND | 0 | ||||||||||
| 125820252 | 12582025 | 20 | C | ARANESP | DARBEPOETIN ALFA | 1 | Subcutaneous | 0 | 150 | UG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125820252 | 12582025 | 1 | B-cell lymphoma |
| 125820252 | 12582025 | 2 | B-cell lymphoma |
| 125820252 | 12582025 | 3 | B-cell lymphoma |
| 125820252 | 12582025 | 4 | B-cell lymphoma |
| 125820252 | 12582025 | 5 | B-cell lymphoma |
| 125820252 | 12582025 | 6 | Oral infection |
| 125820252 | 12582025 | 7 | Oral infection |
| 125820252 | 12582025 | 8 | Oral infection |
| 125820252 | 12582025 | 9 | Oesophagitis |
| 125820252 | 12582025 | 10 | Hypercalcaemia |
| 125820252 | 12582025 | 11 | Premedication |
| 125820252 | 12582025 | 12 | Premedication |
| 125820252 | 12582025 | 13 | Infusion related reaction |
| 125820252 | 12582025 | 14 | Infusion related reaction |
| 125820252 | 12582025 | 15 | Infusion related reaction |
| 125820252 | 12582025 | 16 | Constipation |
| 125820252 | 12582025 | 17 | Constipation |
| 125820252 | 12582025 | 18 | Nausea |
| 125820252 | 12582025 | 19 | Dyspepsia |
| 125820252 | 12582025 | 20 | Anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125820252 | 12582025 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125820252 | 12582025 | Asthenia | |
| 125820252 | 12582025 | Diarrhoea | |
| 125820252 | 12582025 | Febrile neutropenia | |
| 125820252 | 12582025 | Leukopenia |
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 |
|---|---|---|---|---|---|---|
| 125820252 | 12582025 | 1 | 20160701 | 0 | ||
| 125820252 | 12582025 | 2 | 20160630 | 0 | ||
| 125820252 | 12582025 | 3 | 20160629 | 0 | ||
| 125820252 | 12582025 | 4 | 20160630 | 0 | ||
| 125820252 | 12582025 | 5 | 20160630 | 0 | ||
| 125820252 | 12582025 | 6 | 20160629 | 0 | ||
| 125820252 | 12582025 | 7 | 20160629 | 0 | ||
| 125820252 | 12582025 | 8 | 20160629 | 0 | ||
| 125820252 | 12582025 | 9 | 20160629 | 0 | ||
| 125820252 | 12582025 | 10 | 20160629 | 20160629 | 0 | |
| 125820252 | 12582025 | 11 | 20160630 | 0 | ||
| 125820252 | 12582025 | 12 | 20160630 | 0 | ||
| 125820252 | 12582025 | 13 | 20160630 | 20160630 | 0 | |
| 125820252 | 12582025 | 14 | 20160630 | 20160630 | 0 | |
| 125820252 | 12582025 | 15 | 20160630 | 20160630 | 0 | |
| 125820252 | 12582025 | 16 | 20160701 | 20160706 | 0 | |
| 125820252 | 12582025 | 17 | 20160706 | 20160706 | 0 | |
| 125820252 | 12582025 | 18 | 20160707 | 20160707 | 0 | |
| 125820252 | 12582025 | 19 | 20160707 | 20160707 | 0 | |
| 125820252 | 12582025 | 20 | 20160713 | 0 |