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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127646122 | 12764612 | 2 | F | 20160913 | 20160915 | 20160920 | 20160928 | EXP | FR-TAKEDA-2016MPI008190 | TAKEDA | 55.00 | YR | M | Y | 86.00000 | KG | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127646122 | 12764612 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.3 MG/M2, UNK | 21602 | 1.3 | MG/M**2 | INJECTION | |||||||
| 127646122 | 12764612 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 127646122 | 12764612 | 3 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 16 MG/KG, UNK | 0 | 16 | MG/KG | ||||||||
| 127646122 | 12764612 | 4 | SS | THALIDOMIDE | THALIDOMIDE | 1 | Oral | 100 MG, QD | 11000 | MG | 0 | 100 | MG | QD | |||||
| 127646122 | 12764612 | 5 | C | FERRO-SEQUELS | 2 | Unknown | UNK | D | 0 | ||||||||||
| 127646122 | 12764612 | 6 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Unknown | UNK | D | 0 | |||||||||
| 127646122 | 12764612 | 7 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 6 MG, QD | D | 0 | 6 | MG | CAPSULE | QD | |||||
| 127646122 | 12764612 | 8 | C | OXYNORM | OXYCODONE HYDROCHLORIDE | 1 | Unknown | UNK | D | 0 | |||||||||
| 127646122 | 12764612 | 9 | C | MICROLAX /00285401/ | 2 | Unknown | UNK | D | 0 | ||||||||||
| 127646122 | 12764612 | 10 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | UNK | D | 0 | |||||||||
| 127646122 | 12764612 | 11 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 10 MG, BID | D | 0 | 10 | MG | TABLET | BID | |||||
| 127646122 | 12764612 | 12 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Unknown | 75 MG, QD | D | 0 | 75 | MG | QD | ||||||
| 127646122 | 12764612 | 13 | C | WELLVONE | ATOVAQUONE | 1 | Unknown | 760 MG, BID | D | 0 | 760 | MG | BID | ||||||
| 127646122 | 12764612 | 14 | SS | ROXITHROMYCIN | ROXITHROMYCIN | 1 | Unknown | 150 MG, QD | D | 0 | 150 | MG | TABLET | QD | |||||
| 127646122 | 12764612 | 15 | SS | RANITIDINE. | RANITIDINE | 1 | Unknown | 150 MG, BID | D | 0 | 150 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127646122 | 12764612 | 1 | Plasma cell myeloma |
| 127646122 | 12764612 | 2 | Plasma cell myeloma |
| 127646122 | 12764612 | 3 | Plasma cell myeloma |
| 127646122 | 12764612 | 4 | Plasma cell myeloma |
| 127646122 | 12764612 | 5 | Haematotoxicity |
| 127646122 | 12764612 | 6 | Constipation |
| 127646122 | 12764612 | 7 | Hypertension |
| 127646122 | 12764612 | 8 | Bone pain |
| 127646122 | 12764612 | 9 | Constipation |
| 127646122 | 12764612 | 10 | Nausea |
| 127646122 | 12764612 | 11 | Bone pain |
| 127646122 | 12764612 | 12 | Thrombosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127646122 | 12764612 | HO |
| 127646122 | 12764612 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127646122 | 12764612 | Constipation | |
| 127646122 | 12764612 | Nausea | |
| 127646122 | 12764612 | Pyrexia | |
| 127646122 | 12764612 | Varicella |
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 |
|---|---|---|---|---|---|---|
| 127646122 | 12764612 | 1 | 20160527 | 0 | ||
| 127646122 | 12764612 | 2 | 20160527 | 0 | ||
| 127646122 | 12764612 | 3 | 20160527 | 0 | ||
| 127646122 | 12764612 | 4 | 20160527 | 20160916 | 0 | |
| 127646122 | 12764612 | 9 | 20160603 | 0 | ||
| 127646122 | 12764612 | 10 | 20160603 | 0 | ||
| 127646122 | 12764612 | 11 | 20160701 | 0 | ||
| 127646122 | 12764612 | 12 | 20160527 | 0 |