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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
121426389 | 12142638 | 9 | F | 20150807 | 20160804 | 20160303 | 20160815 | EXP | BG-TAKEDA-2016MPI001498 | TAKEDA | 69.00 | YR | F | Y | 61.00000 | KG | 20160815 | MD | BG | BG |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
121426389 | 12142638 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, 2/WEEK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | BIW | |||||
121426389 | 12142638 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | BIW | |||||
121426389 | 12142638 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 4 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 5 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 6 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 7 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 8 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 9 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 10 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 11 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 12 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 13 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 14 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.08 MG, UNK | V14036-08;V14036-10 +MORE | 21602 | 2.8 | MG | INJECTION | ||||||
121426389 | 12142638 | 15 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 100 MG, UNK | 4370387 | 0 | 100 | MG | |||||||
121426389 | 12142638 | 16 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 100 MG, UNK | 4370387 | 0 | 100 | MG | |||||||
121426389 | 12142638 | 17 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 100 MG, UNK | 4370387 | 0 | 100 | MG | |||||||
121426389 | 12142638 | 18 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 976 MG, 1/WEEK | 058998-01;058998-02 | 0 | 976 | MG | /wk | ||||||
121426389 | 12142638 | 19 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 976 MG, UNK | 058998-01;058998-02 | 0 | 976 | MG | |||||||
121426389 | 12142638 | 20 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 14 MG, UNK | 4370421 | 0 | 14 | MG | |||||||
121426389 | 12142638 | 21 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 14 MG, UNK | 4370421 | 0 | 14 | MG | |||||||
121426389 | 12142638 | 22 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 14 MG, UNK | 4370421 | 0 | 14 | MG | |||||||
121426389 | 12142638 | 23 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 16 MG, UNK | 0 | 16 | MG | ||||||||
121426389 | 12142638 | 24 | C | MAXIPIM | 2 | Intravenous (not otherwise specified) | 1000 MG, BID | 14000 | MG | 0 | 1000 | MG | INJECTION | BID | |||||
121426389 | 12142638 | 25 | C | MERONEM | MEROPENEM | 1 | Intravenous (not otherwise specified) | 2000 MG, TID | 0 | 2000 | MG | INJECTION | TID | ||||||
121426389 | 12142638 | 26 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Intravenous (not otherwise specified) | 200 MG, BID | 2800 | MG | 0 | 200 | MG | INJECTION | BID | ||||
121426389 | 12142638 | 27 | C | TEVAGRASTIM | FILGRASTIM | 1 | Subcutaneous | 300 ?G, UNK | 0 | 300 | UG | INJECTION | |||||||
121426389 | 12142638 | 28 | C | HUMAN ALBUMIN | ALBUMIN HUMAN | 1 | Intravenous (not otherwise specified) | 100 MG, UNK | 0 | 100 | MG | INJECTION | |||||||
121426389 | 12142638 | 29 | C | ACYCLOVIR /00587301/ | ACYCLOVIR | 1 | Oral | 400 MG, BID | 21600 | MG | 0 | 400 | MG | TABLET | BID | ||||
121426389 | 12142638 | 30 | C | BISEPTOL | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 960 MG, 2/WEEK | 0 | 960 | MG | TABLET | BIW |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
121426389 | 12142638 | 1 | Plasma cell myeloma |
121426389 | 12142638 | 15 | Plasma cell myeloma |
121426389 | 12142638 | 18 | Plasma cell myeloma |
121426389 | 12142638 | 20 | Plasma cell myeloma |
121426389 | 12142638 | 24 | Neutropenia |
121426389 | 12142638 | 25 | Neutropenia |
121426389 | 12142638 | 26 | Neutropenia |
121426389 | 12142638 | 27 | Neutropenia |
121426389 | 12142638 | 28 | Hypoalbuminaemia |
121426389 | 12142638 | 29 | Prophylaxis |
121426389 | 12142638 | 30 | Prophylaxis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
121426389 | 12142638 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
121426389 | 12142638 | Anaemia | |
121426389 | 12142638 | Hypoalbuminaemia | |
121426389 | 12142638 | Neutropenia | |
121426389 | 12142638 | Pleural effusion | |
121426389 | 12142638 | 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 |
---|---|---|---|---|---|---|
121426389 | 12142638 | 1 | 20150724 | 0 | ||
121426389 | 12142638 | 2 | 20150727 | 0 | ||
121426389 | 12142638 | 3 | 20150731 | 0 | ||
121426389 | 12142638 | 4 | 20150803 | 0 | ||
121426389 | 12142638 | 5 | 20150814 | 0 | ||
121426389 | 12142638 | 6 | 20150817 | 0 | ||
121426389 | 12142638 | 7 | 20150821 | 0 | ||
121426389 | 12142638 | 8 | 20150824 | 0 | ||
121426389 | 12142638 | 9 | 20150904 | 0 | ||
121426389 | 12142638 | 10 | 20150911 | 0 | ||
121426389 | 12142638 | 11 | 20150925 | 0 | ||
121426389 | 12142638 | 12 | 20151002 | 0 | ||
121426389 | 12142638 | 13 | 20151016 | 0 | ||
121426389 | 12142638 | 14 | 20151023 | 0 | ||
121426389 | 12142638 | 15 | 20150724 | 20150727 | 0 | |
121426389 | 12142638 | 16 | 20150905 | 20150907 | 0 | |
121426389 | 12142638 | 17 | 20151017 | 20151019 | 0 | |
121426389 | 12142638 | 18 | 20150724 | 0 | ||
121426389 | 12142638 | 19 | 20150814 | 0 | ||
121426389 | 12142638 | 20 | 20150724 | 20150727 | 0 | |
121426389 | 12142638 | 21 | 20150904 | 20150907 | 0 | |
121426389 | 12142638 | 22 | 20151016 | 20151019 | 0 | |
121426389 | 12142638 | 23 | 20150726 | 20150727 | 0 | |
121426389 | 12142638 | 24 | 20150818 | 20150824 | 0 | |
121426389 | 12142638 | 25 | 20150825 | 20150828 | 0 | |
121426389 | 12142638 | 26 | 20150818 | 20150824 | 0 | |
121426389 | 12142638 | 27 | 20150818 | 20150826 | 0 | |
121426389 | 12142638 | 28 | 20150818 | 20150820 | 0 | |
121426389 | 12142638 | 29 | 20150729 | 20150826 | 0 | |
121426389 | 12142638 | 30 | 20150729 | 20150826 | 0 |