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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123403242 | 12340324 | 2 | F | 20140703 | 20160707 | 20160506 | 20160712 | EXP | BR-ROCHE-1430745 | ROCHE | 62.75 | YR | F | Y | 75.00000 | KG | 20160712 | MD | BR | BR |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123403242 | 12340324 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO EVENT : 17/JUN/2014 MOST RECENT DOSE PRIOR TO EVENT ON 03/JUL/2014, 03/SE | 103705 | 670 | MG | SOLUTION FOR INFUSION | |||||||
123403242 | 12340324 | 2 | SS | Rituximab | RITUXIMAB | 1 | Subcutaneous | LAST DOSE PRIOR TO SAE-30/JUL/2014, 03/SEP/2014 | 1105214,1105211 | 103705 | 1400 | MG | SOLUTION FOR INJECTION | ||||||
123403242 | 12340324 | 3 | SS | Rituximab | RITUXIMAB | 1 | Subcutaneous | LAST DOSE PRIOR TO SAE-06/OCT/2014 | 1105214,1105211 | 103705 | 1400 | MG | SOLUTION FOR INJECTION | ||||||
123403242 | 12340324 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | ||||||||||
123403242 | 12340324 | 5 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Unknown | U | 0 | ||||||||||
123403242 | 12340324 | 6 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | U | 0 | ||||||||||
123403242 | 12340324 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
123403242 | 12340324 | 8 | C | DIAZEPAM. | DIAZEPAM | 1 | Oral | 0 | 10 | MG | |||||||||
123403242 | 12340324 | 9 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 0 | 75 | UG | |||||||||
123403242 | 12340324 | 10 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 0 | 88 | UG | |||||||||
123403242 | 12340324 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | |||||||||
123403242 | 12340324 | 12 | C | DOMPERIDONE | DOMPERIDONE | 1 | Oral | 0 | |||||||||||
123403242 | 12340324 | 13 | C | CEPHALEXIN. | CEPHALEXIN | 1 | Oral | 0 | 500 | MG | Q6H | ||||||||
123403242 | 12340324 | 14 | C | KETOPROFEN. | KETOPROFEN | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | Q12H | ||||||||
123403242 | 12340324 | 15 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 0 | 50 | MG | Q6H | ||||||||
123403242 | 12340324 | 16 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 0 | 50 | MG | Q8H | ||||||||
123403242 | 12340324 | 17 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 0 | 50 | MG | Q8H | ||||||||
123403242 | 12340324 | 18 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 0 | 50 | MG | Q8H | ||||||||
123403242 | 12340324 | 19 | C | DIMORF | MORPHINE SULFATE | 1 | Oral | 0 | 10 | MG | Q6H | ||||||||
123403242 | 12340324 | 20 | C | DIMORF | MORPHINE SULFATE | 1 | Unknown | 0 | 10 | MG | |||||||||
123403242 | 12340324 | 21 | C | ENOXAPARIN | ENOXAPARIN | 1 | Subcutaneous | 0 | 60 | MG | Q12H | ||||||||
123403242 | 12340324 | 22 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 5 | MG | |||||||||
123403242 | 12340324 | 23 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 7.5 | MG | |||||||||
123403242 | 12340324 | 24 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 7.5 | MG | |||||||||
123403242 | 12340324 | 25 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 10 | MG | |||||||||
123403242 | 12340324 | 26 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 12.5 | MG | |||||||||
123403242 | 12340324 | 27 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 10 | MG | |||||||||
123403242 | 12340324 | 28 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 12.5 | MG | |||||||||
123403242 | 12340324 | 29 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 12.5 | MG | |||||||||
123403242 | 12340324 | 30 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 10 | MG | |||||||||
123403242 | 12340324 | 31 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 12.5 | MG | |||||||||
123403242 | 12340324 | 32 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | 10 | MG | |||||||||
123403242 | 12340324 | 33 | C | LACTULONA | 2 | Oral | 0 | 10 | ML | Q12H | |||||||||
123403242 | 12340324 | 34 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 750 | MG | CAPSULE | ||||||||
123403242 | 12340324 | 35 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 1 CAPSULE | 0 | CAPSULE | Q6H | ||||||||
123403242 | 12340324 | 36 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
123403242 | 12340324 | 37 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 750 | MG | |||||||||
123403242 | 12340324 | 38 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 750 | MG | |||||||||
123403242 | 12340324 | 39 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 750 | MG | |||||||||
123403242 | 12340324 | 40 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 750 | MG | |||||||||
123403242 | 12340324 | 41 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 750 | MG | |||||||||
123403242 | 12340324 | 42 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 750 | MG | |||||||||
123403242 | 12340324 | 43 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 0 | 8 | MG | Q8H | ||||||||
123403242 | 12340324 | 44 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 0 | 8 | MG | Q8H | ||||||||
123403242 | 12340324 | 45 | C | BROMOPRIDE | BROMOPRIDE | 1 | Intravenous (not otherwise specified) | 0 | 10 | MG | Q6H | ||||||||
123403242 | 12340324 | 46 | C | BROMOPRIDE | BROMOPRIDE | 1 | Intravenous (not otherwise specified) | 0 | 10 | MG | Q8H | ||||||||
123403242 | 12340324 | 47 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 2 | G | Q12H | ||||||||
123403242 | 12340324 | 48 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | 0 | ||||||||||||
123403242 | 12340324 | 49 | C | VANCOMYCINE | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 0 | 1 | G | Q12H | ||||||||
123403242 | 12340324 | 50 | C | VANCOMYCINE | VANCOMYCIN | 1 | 0 | ||||||||||||
123403242 | 12340324 | 51 | C | MINERAL OIL. | MINERAL OIL | 1 | Oral | 0 | 10 | ML | Q8H | ||||||||
123403242 | 12340324 | 52 | C | CODEINE | CODEINE | 1 | Oral | 1 CAPSULE | 0 | CAPSULE | Q6H | ||||||||
123403242 | 12340324 | 53 | C | CODEINE | CODEINE | 1 | Oral | 0 | 30 | MG | |||||||||
123403242 | 12340324 | 54 | C | SCOPOLAMINE BUTYLBROMIDE | SCOPOLAMINE | 1 | Oral | 40 DROPS | 0 | Q6H | |||||||||
123403242 | 12340324 | 55 | C | NAUSEDRON | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | QD | ||||||||
123403242 | 12340324 | 56 | C | NAUSEDRON | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | QD | ||||||||
123403242 | 12340324 | 57 | C | NAUSEDRON | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | QD | ||||||||
123403242 | 12340324 | 58 | C | NAUSEDRON | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | QD | ||||||||
123403242 | 12340324 | 59 | C | NAUSEDRON | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | QD | ||||||||
123403242 | 12340324 | 60 | C | NAUSEDRON | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | QD | ||||||||
123403242 | 12340324 | 61 | C | NAUSEDRON | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | QD | ||||||||
123403242 | 12340324 | 62 | C | NAUSEDRON | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | QD | ||||||||
123403242 | 12340324 | 63 | C | DICLOFENAC | DICLOFENAC | 1 | Intramuscular | 0 | 75 | MG | |||||||||
123403242 | 12340324 | 64 | C | DICLOFENAC | DICLOFENAC | 1 | Intramuscular | 0 | 50 | MG | Q8H | ||||||||
123403242 | 12340324 | 65 | C | DEXALGEN | DEXAMETHASONE SODIUM PHOSPHATEHYDROXOCOBALAMINMETAMIZOLE SODIUM | 1 | Intramuscular | 1 AMPOULE | 0 | ||||||||||
123403242 | 12340324 | 66 | C | PROFENID | KETOPROFEN | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | Q12H | ||||||||
123403242 | 12340324 | 67 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | |||||||||
123403242 | 12340324 | 68 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | |||||||||
123403242 | 12340324 | 69 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | |||||||||
123403242 | 12340324 | 70 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | |||||||||
123403242 | 12340324 | 71 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | |||||||||
123403242 | 12340324 | 72 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | |||||||||
123403242 | 12340324 | 73 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | |||||||||
123403242 | 12340324 | 74 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
123403242 | 12340324 | 1 | Diffuse large B-cell lymphoma |
123403242 | 12340324 | 2 | Diffuse large B-cell lymphoma |
123403242 | 12340324 | 4 | Diffuse large B-cell lymphoma |
123403242 | 12340324 | 5 | Diffuse large B-cell lymphoma |
123403242 | 12340324 | 6 | Diffuse large B-cell lymphoma |
123403242 | 12340324 | 7 | Diffuse large B-cell lymphoma |
123403242 | 12340324 | 8 | Insomnia |
123403242 | 12340324 | 9 | Hypothyroidism |
123403242 | 12340324 | 11 | Gastritis |
123403242 | 12340324 | 12 | Gastritis |
123403242 | 12340324 | 13 | Infection |
123403242 | 12340324 | 14 | Cancer pain |
123403242 | 12340324 | 15 | Cancer pain |
123403242 | 12340324 | 16 | Cancer pain |
123403242 | 12340324 | 19 | Cancer pain |
123403242 | 12340324 | 21 | Deep vein thrombosis |
123403242 | 12340324 | 22 | Deep vein thrombosis |
123403242 | 12340324 | 33 | Constipation |
123403242 | 12340324 | 34 | Premedication |
123403242 | 12340324 | 43 | Prophylaxis of nausea and vomiting |
123403242 | 12340324 | 45 | Prophylaxis of nausea and vomiting |
123403242 | 12340324 | 47 | Febrile neutropenia |
123403242 | 12340324 | 48 | Sepsis |
123403242 | 12340324 | 49 | Febrile neutropenia |
123403242 | 12340324 | 50 | Sepsis |
123403242 | 12340324 | 51 | Constipation |
123403242 | 12340324 | 52 | Cancer pain |
123403242 | 12340324 | 54 | Abdominal pain |
123403242 | 12340324 | 67 | Premedication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
123403242 | 12340324 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
123403242 | 12340324 | Anaemia | |
123403242 | 12340324 | Lymphocyte count decreased | |
123403242 | 12340324 | Neutrophil count decreased |
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 |
---|---|---|---|---|---|---|
123403242 | 12340324 | 1 | 20140407 | 0 | ||
123403242 | 12340324 | 2 | 20140703 | 20141006 | 0 | |
123403242 | 12340324 | 3 | 20140707 | 0 | ||
123403242 | 12340324 | 8 | 1984 | 0 | ||
123403242 | 12340324 | 9 | 201312 | 20140924 | 0 | |
123403242 | 12340324 | 10 | 20140925 | 0 | ||
123403242 | 12340324 | 11 | 2009 | 0 | ||
123403242 | 12340324 | 12 | 201401 | 0 | ||
123403242 | 12340324 | 13 | 20140327 | 20140402 | 0 | |
123403242 | 12340324 | 14 | 20130327 | 20140329 | 0 | |
123403242 | 12340324 | 15 | 20140704 | 20140712 | 0 | |
123403242 | 12340324 | 16 | 20140402 | 20140403 | 0 | |
123403242 | 12340324 | 17 | 20140404 | 20140405 | 0 | |
123403242 | 12340324 | 18 | 20140329 | 20140401 | 0 | |
123403242 | 12340324 | 19 | 20140406 | 20140527 | 0 | |
123403242 | 12340324 | 20 | 20150103 | 0 | ||
123403242 | 12340324 | 21 | 20140403 | 20140428 | 0 | |
123403242 | 12340324 | 22 | 20140404 | 20140406 | 0 | |
123403242 | 12340324 | 23 | 20140407 | 20140408 | 0 | |
123403242 | 12340324 | 24 | 20140417 | 20140418 | 0 | |
123403242 | 12340324 | 25 | 20140419 | 20140422 | 0 | |
123403242 | 12340324 | 26 | 20140515 | 0 | ||
123403242 | 12340324 | 27 | 20140516 | 0 | ||
123403242 | 12340324 | 28 | 20140423 | 20140515 | 0 | |
123403242 | 12340324 | 29 | 20141008 | 20141104 | 0 | |
123403242 | 12340324 | 30 | 20141009 | 20141104 | 0 | |
123403242 | 12340324 | 31 | 20141106 | 0 | ||
123403242 | 12340324 | 32 | 20141107 | 0 | ||
123403242 | 12340324 | 33 | 20140401 | 0 | ||
123403242 | 12340324 | 34 | 20140407 | 20140407 | 0 | |
123403242 | 12340324 | 35 | 20140527 | 20140704 | 0 | |
123403242 | 12340324 | 36 | 20140713 | 20140730 | 0 | |
123403242 | 12340324 | 37 | 20140405 | 20140405 | 0 | |
123403242 | 12340324 | 38 | 20140527 | 20140527 | 0 | |
123403242 | 12340324 | 39 | 20140617 | 20140617 | 0 | |
123403242 | 12340324 | 40 | 20140709 | 20140709 | 0 | |
123403242 | 12340324 | 41 | 20140903 | 20140903 | 0 | |
123403242 | 12340324 | 42 | 20141006 | 20141006 | 0 | |
123403242 | 12340324 | 43 | 20140407 | 20140407 | 0 | |
123403242 | 12340324 | 44 | 20140408 | 20140410 | 0 | |
123403242 | 12340324 | 45 | 20140407 | 20140407 | 0 | |
123403242 | 12340324 | 46 | 20140408 | 20140410 | 0 | |
123403242 | 12340324 | 47 | 20140424 | 20140505 | 0 | |
123403242 | 12340324 | 49 | 20140428 | 20140504 | 0 | |
123403242 | 12340324 | 51 | 20140426 | 20140523 | 0 | |
123403242 | 12340324 | 52 | 20140527 | 20140704 | 0 | |
123403242 | 12340324 | 53 | 20140713 | 20140730 | 0 | |
123403242 | 12340324 | 54 | 20140524 | 20140525 | 0 | |
123403242 | 12340324 | 55 | 20140407 | 20140407 | 0 | |
123403242 | 12340324 | 56 | 20140505 | 20140505 | 0 | |
123403242 | 12340324 | 57 | 20140527 | 20140527 | 0 | |
123403242 | 12340324 | 58 | 20140617 | 20140617 | 0 | |
123403242 | 12340324 | 59 | 20140709 | 20140709 | 0 | |
123403242 | 12340324 | 60 | 20140730 | 20140730 | 0 | |
123403242 | 12340324 | 61 | 20140903 | 20140903 | 0 | |
123403242 | 12340324 | 62 | 20141006 | 20141006 | 0 | |
123403242 | 12340324 | 63 | 20141230 | 20141230 | 0 | |
123403242 | 12340324 | 64 | 20150102 | 20150103 | 0 | |
123403242 | 12340324 | 65 | 20150103 | 0 | ||
123403242 | 12340324 | 66 | 20150104 | 0 | ||
123403242 | 12340324 | 67 | 20140407 | 20140407 | 0 | |
123403242 | 12340324 | 68 | 20140505 | 20140505 | 0 | |
123403242 | 12340324 | 69 | 20140527 | 20140527 | 0 | |
123403242 | 12340324 | 70 | 20140617 | 20140617 | 0 | |
123403242 | 12340324 | 71 | 20140709 | 20140709 | 0 | |
123403242 | 12340324 | 72 | 20140730 | 20140730 | 0 | |
123403242 | 12340324 | 73 | 20140903 | 20140903 | 0 | |
123403242 | 12340324 | 74 | 20141006 | 20141006 | 0 |