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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125775392 | 12577539 | 2 | F | 20160630 | 20160730 | 20160720 | 20160804 | EXP | US-TAKEDA-2016MPI006172 | TAKEDA | 52.49 | YR | M | Y | 82.90000 | KG | 20160804 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125775392 | 12577539 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.6 MG, UNK | U | 21602 | 2.6 | MG | INJECTION | ||||||
| 125775392 | 12577539 | 2 | SS | Doxorubicin | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 80 MG, UNK | U | 0 | 80 | MG | INJECTION | ||||||
| 125775392 | 12577539 | 3 | SS | DECITABINE. | DECITABINE | 1 | Intravenous (not otherwise specified) | 40.1 MG, UNK | U | 0 | 40.1 | MG | INJECTION | ||||||
| 125775392 | 12577539 | 4 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 125775392 | 12577539 | 5 | C | ZOVIRAX | ACYCLOVIR | 1 | Oral | 200 MG, BID | U | 0 | 200 | MG | CAPSULE | BID | |||||
| 125775392 | 12577539 | 6 | C | ZOVIRAX | ACYCLOVIR | 1 | Oral | 400 MG, BID | U | 0 | 400 | MG | CAPSULE | BID | |||||
| 125775392 | 12577539 | 7 | C | COLACE | DOCUSATE SODIUM | 1 | Oral | 100 MG, BID | U | 0 | 100 | MG | CAPSULE | BID | |||||
| 125775392 | 12577539 | 8 | C | LEVAQUIN | LEVOFLOXACIN | 1 | Oral | 500 MG, QD | U | 0 | 500 | MG | TABLET | QD | |||||
| 125775392 | 12577539 | 9 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | 500 MG, TID | U | 0 | 500 | MG | TABLET | TID | |||||
| 125775392 | 12577539 | 10 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 4 MG, UNK | U | 0 | 4 | MG | TABLET | ||||||
| 125775392 | 12577539 | 11 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | U | 0 | 8 | MG | TABLET | ||||||
| 125775392 | 12577539 | 12 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 10 MG, UNK | U | 0 | 10 | MG | TABLET | ||||||
| 125775392 | 12577539 | 13 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 17 G, QD | U | 0 | 17 | G | QD | ||||||
| 125775392 | 12577539 | 14 | C | NOXAFIL | POSACONAZOLE | 1 | Oral | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 125775392 | 12577539 | 15 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 300 MG, TID | U | 0 | 300 | MG | CAPSULE | TID | |||||
| 125775392 | 12577539 | 16 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 1200 MG, TID | U | 0 | 1200 | MG | CAPSULE | TID | |||||
| 125775392 | 12577539 | 17 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 600 MG, TID | U | 0 | 600 | MG | CAPSULE | TID | |||||
| 125775392 | 12577539 | 18 | C | ZYLOPRIM | ALLOPURINOL | 1 | Oral | 300 MG, QD | U | 0 | 300 | MG | QD | ||||||
| 125775392 | 12577539 | 19 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | U | 0 | QD | |||||||||
| 125775392 | 12577539 | 20 | C | DACOGEN | DECITABINE | 1 | Intravenous (not otherwise specified) | 38 MG, UNK | U | 0 | 38 | MG | |||||||
| 125775392 | 12577539 | 21 | C | MEGACE | MEGESTROL ACETATE | 1 | Oral | 20 MG, BID | U | 0 | 20 | MG | BID | ||||||
| 125775392 | 12577539 | 22 | C | BEN-GAY ARTHRITIS | 2 | Topical | UNK, TID | U | 0 | TID | |||||||||
| 125775392 | 12577539 | 23 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 10 MG, BID | U | 0 | 10 | MG | BID | ||||||
| 125775392 | 12577539 | 24 | C | MYCAMINE | MICAFUNGIN SODIUM | 1 | Intravenous (not otherwise specified) | 50 MG, QD | U | 0 | 50 | MG | QD | ||||||
| 125775392 | 12577539 | 25 | C | REMERON | MIRTAZAPINE | 1 | Oral | 7.5 MG, UNK | U | 0 | 7.5 | MG | |||||||
| 125775392 | 12577539 | 26 | C | MS CONTIN | MORPHINE SULFATE | 1 | Oral | 30 MG, UNK | U | 0 | 30 | MG | |||||||
| 125775392 | 12577539 | 27 | C | MS CONTIN | MORPHINE SULFATE | 1 | 15 MG, UNK | U | 0 | 15 | MG | ||||||||
| 125775392 | 12577539 | 28 | C | VENETOCLAX | VENETOCLAX | 1 | Oral | 200 MG, UNK | U | 0 | 200 | MG | |||||||
| 125775392 | 12577539 | 29 | C | VENETOCLAX | VENETOCLAX | 1 | Oral | 400 MG, UNK | U | 0 | 400 | MG | |||||||
| 125775392 | 12577539 | 30 | C | VENETOCLAX | VENETOCLAX | 1 | Oral | 800 MG, QD | U | 0 | 800 | MG | QD | ||||||
| 125775392 | 12577539 | 31 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 150 MG, QD | U | 0 | 150 | MG | QD | ||||||
| 125775392 | 12577539 | 32 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | U | 0 | |||||||||||
| 125775392 | 12577539 | 33 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | 650 MG, Q4HR | U | 0 | 650 | MG | Q4H | |||||||
| 125775392 | 12577539 | 34 | C | ALBUTEROL /00139501/ | ALBUTEROL | 1 | 2.5 MG, UNK | U | 0 | 2.5 | MG | ||||||||
| 125775392 | 12577539 | 35 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | 1000 MG, Q6HR | U | 0 | 1000 | MG | Q6H | |||||||
| 125775392 | 12577539 | 36 | C | ALTEPLASE | ALTEPLASE | 1 | 2 MG, UNK | U | 0 | 2 | MG | ||||||||
| 125775392 | 12577539 | 37 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | U | 0 | |||||||||||
| 125775392 | 12577539 | 38 | C | EPINEPHRINE. | EPINEPHRINE | 1 | 0.3 MG, UNK | U | 0 | .3 | MG | ||||||||
| 125775392 | 12577539 | 39 | C | FAMOTIDINE. | FAMOTIDINE | 1 | 20 MG, UNK | U | 0 | 20 | MG | ||||||||
| 125775392 | 12577539 | 40 | C | HEPARIN | HEPARIN SODIUM | 1 | 3 ML, UNK | U | 0 | 3 | ML | ||||||||
| 125775392 | 12577539 | 41 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK, Q4HR | U | 0 | Q4H | |||||||||
| 125775392 | 12577539 | 42 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 125 MG, UNK | U | 0 | 125 | MG | ||||||||
| 125775392 | 12577539 | 43 | C | ONDANSETRON | ONDANSETRON | 1 | 4 MG, UNK | U | 0 | 4 | MG | ||||||||
| 125775392 | 12577539 | 44 | C | OXYCODONE /00045603/ | OXYCODONE | 1 | UNK, Q3HR | U | 0 | Q3H | |||||||||
| 125775392 | 12577539 | 45 | C | OXYCODONE /00045603/ | OXYCODONE | 1 | 10 MG, UNK | U | 0 | 10 | MG | ||||||||
| 125775392 | 12577539 | 46 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | 10 MG, Q6HR | U | 0 | 10 | MG | Q6H | |||||||
| 125775392 | 12577539 | 47 | C | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | 15 MG, UNK | U | 0 | 15 | MG | ||||||||
| 125775392 | 12577539 | 48 | C | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | U | 0 | |||||||||||
| 125775392 | 12577539 | 49 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0.5 MG, UNK | U | 0 | .5 | MG | ||||||||
| 125775392 | 12577539 | 50 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 650 MG, Q4HR | U | 0 | 650 | MG | Q4H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125775392 | 12577539 | 1 | Acute myeloid leukaemia |
| 125775392 | 12577539 | 2 | Acute myeloid leukaemia |
| 125775392 | 12577539 | 3 | Acute myeloid leukaemia |
| 125775392 | 12577539 | 4 | Headache |
| 125775392 | 12577539 | 12 | Pain |
| 125775392 | 12577539 | 13 | Constipation |
| 125775392 | 12577539 | 15 | Neuropathy peripheral |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125775392 | 12577539 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125775392 | 12577539 | Decreased appetite | |
| 125775392 | 12577539 | Fatigue | |
| 125775392 | 12577539 | Muscular weakness | |
| 125775392 | 12577539 | Neuralgia | |
| 125775392 | 12577539 | Peripheral sensory neuropathy | |
| 125775392 | 12577539 | Presyncope |
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 |
|---|---|---|---|---|---|---|
| 125775392 | 12577539 | 1 | 20160603 | 20160613 | 0 | |
| 125775392 | 12577539 | 2 | 20160606 | 0 | ||
| 125775392 | 12577539 | 3 | 20160603 | 20160612 | 0 | |
| 125775392 | 12577539 | 28 | 20160729 | 0 | ||
| 125775392 | 12577539 | 29 | 20160730 | 0 | ||
| 125775392 | 12577539 | 30 | 20160731 | 0 |