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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118956697 | 11895669 | 7 | F | 20151225 | 20160714 | 20160107 | 20160720 | EXP | MX-TAKEDA-2016MPI000046 | TAKEDA | 68.64 | YR | F | Y | 79.00000 | KG | 20160720 | OT | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118956697 | 11895669 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.3 MG/M2, 2/WEEK | Y | 4369727 | 21602 | 1.3 | MG/M**2 | INJECTION | BIW | ||||
| 118956697 | 11895669 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 20 MG, UNK | U | 0 | 20 | MG | TABLET | ||||||
| 118956697 | 11895669 | 3 | SS | Daratumumab | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 16 MG/KG, Q3WEEKS | Y | 4370578 | 0 | 16 | MG/KG | INTRAVENOUS INFUSION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118956697 | 11895669 | 1 | Plasma cell myeloma |
| 118956697 | 11895669 | 2 | Plasma cell myeloma |
| 118956697 | 11895669 | 3 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118956697 | 11895669 | DE |
| 118956697 | 11895669 | HO |
| 118956697 | 11895669 | OT |
| 118956697 | 11895669 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118956697 | 11895669 | Atrial fibrillation | |
| 118956697 | 11895669 | Cardiac failure congestive | |
| 118956697 | 11895669 | Pneumonia | |
| 118956697 | 11895669 | Respiratory failure |
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 |
|---|---|---|---|---|---|---|
| 118956697 | 11895669 | 1 | 20151224 | 20151224 | 0 | |
| 118956697 | 11895669 | 2 | 20151214 | 0 | ||
| 118956697 | 11895669 | 3 | 20151221 | 20151221 | 0 |