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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127912381 | 12791238 | 1 | I | 20160804 | 20160927 | 20160929 | 20160929 | EXP | FR-ROCHE-1835668 | ROCHE | 53.00 | YR | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127912381 | 12791238 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | FIRST CYCLE DAY 4 (C1D4) | U | 103705 | 375 | MG/M**2 | SOLUTION FOR INFUSION | /cycle | |||||
| 127912381 | 12791238 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | SECOND CYCLE | U | 103705 | 745 | MG | SOLUTION FOR INFUSION | ||||||
| 127912381 | 12791238 | 3 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | THIRD CYCLE | U | 103705 | 750 | MG | SOLUTION FOR INFUSION | ||||||
| 127912381 | 12791238 | 4 | SS | CISPLATINE | CISPLATIN | 1 | Intravenous (not otherwise specified) | U | 0 | 198 | MG | /cycle | |||||||
| 127912381 | 12791238 | 5 | SS | CISPLATINE | CISPLATIN | 1 | Intravenous (not otherwise specified) | SECOND CYCLE | U | 0 | 198 | MG | |||||||
| 127912381 | 12791238 | 6 | SS | CISPLATINE | CISPLATIN | 1 | Intravenous (not otherwise specified) | U | 0 | 200 | MG | ||||||||
| 127912381 | 12791238 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | C1D1 | 0 | ||||||||||
| 127912381 | 12791238 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | ON DAY 2, 3 AND 4 IN CYCLE 1 | 0 | 40 | MG | ||||||||
| 127912381 | 12791238 | 9 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | CYCLE 2 | 0 | 40 | MG | ||||||||
| 127912381 | 12791238 | 10 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | SUBSEQUENTLY RECEIVED ON 15/SEP/2016 AND 16/SEP/2016 | 0 | 40 | MG | ||||||||
| 127912381 | 12791238 | 11 | C | FASTURTEC | RASBURICASE | 1 | Unknown | 0 | 7.5 | MG | |||||||||
| 127912381 | 12791238 | 12 | C | FASTURTEC | RASBURICASE | 1 | Unknown | 0 | 7.5 | MG | |||||||||
| 127912381 | 12791238 | 13 | C | FASTURTEC | RASBURICASE | 1 | Unknown | 0 | 7.5 | MG | SOLUTION FOR INJECTION | ||||||||
| 127912381 | 12791238 | 14 | C | CYTARABINE. | CYTARABINE | 1 | Unknown | 0 | |||||||||||
| 127912381 | 12791238 | 15 | C | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 3950X2 MG | 0 | ||||||||||
| 127912381 | 12791238 | 16 | C | CYTARABINE. | CYTARABINE | 1 | Unknown | 2X4000 MG | 0 | ||||||||||
| 127912381 | 12791238 | 17 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 0 | 500 | MG | TID | ||||||||
| 127912381 | 12791238 | 18 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | 20 | MG | |||||||||
| 127912381 | 12791238 | 19 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | ON MORNING | 0 | 400 | MG | ||||||||
| 127912381 | 12791238 | 20 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 0 | 100 | MG | |||||||||
| 127912381 | 12791238 | 21 | C | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | Unknown | 0 | 5 | MG | |||||||||
| 127912381 | 12791238 | 22 | C | LORATADINE. | LORATADINE | 1 | Unknown | 0 | 1 | DF | TABLET | ||||||||
| 127912381 | 12791238 | 23 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 1 INJECTION | 0 | 60 | MG | ||||||||
| 127912381 | 12791238 | 24 | C | TOPALGIC (FRANCE) | TRAMADOL | 1 | Unknown | 0 | |||||||||||
| 127912381 | 12791238 | 25 | C | ZOPHREN | ONDANSETRON | 1 | Unknown | 0 | 8 | MG | BID | ||||||||
| 127912381 | 12791238 | 26 | C | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Unknown | 10 MG 2 AMPULES 3 TIMES/DAY | 0 | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127912381 | 12791238 | 1 | Mantle cell lymphoma |
| 127912381 | 12791238 | 4 | Mantle cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127912381 | 12791238 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127912381 | 12791238 | Off label use | |
| 127912381 | 12791238 | Product use issue | |
| 127912381 | 12791238 | Sense of oppression | |
| 127912381 | 12791238 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 127912381 | 12791238 | 1 | 20160804 | 0 | ||
| 127912381 | 12791238 | 2 | 20160823 | 0 | ||
| 127912381 | 12791238 | 3 | 20160913 | 0 | ||
| 127912381 | 12791238 | 4 | 20160801 | 0 | ||
| 127912381 | 12791238 | 5 | 20160823 | 0 | ||
| 127912381 | 12791238 | 6 | 20160913 | 0 | ||
| 127912381 | 12791238 | 7 | 20160801 | 20160801 | 0 | |
| 127912381 | 12791238 | 8 | 20160802 | 20160804 | 0 | |
| 127912381 | 12791238 | 9 | 20160823 | 20160825 | 0 | |
| 127912381 | 12791238 | 10 | 20160913 | 0 | ||
| 127912381 | 12791238 | 11 | 20160803 | 20160804 | 0 | |
| 127912381 | 12791238 | 12 | 20160823 | 0 | ||
| 127912381 | 12791238 | 13 | 20160913 | 0 | ||
| 127912381 | 12791238 | 14 | 20160802 | 0 | ||
| 127912381 | 12791238 | 15 | 20160825 | 0 | ||
| 127912381 | 12791238 | 16 | 20160915 | 0 | ||
| 127912381 | 12791238 | 17 | 201608 | 0 | ||
| 127912381 | 12791238 | 20 | 20160805 | 0 |