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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127092851 | 12709285 | 1 | I | 20140612 | 20160817 | 20160901 | 20160901 | EXP | US-OTSUKA-2016_021150 | OTSUKA | 78.00 | YR | M | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127092851 | 12709285 | 1 | PS | DACOGEN | DECITABINE | 1 | Unknown | UNK | Y | 21790 | INJECTION | ||||||||
| 127092851 | 12709285 | 2 | SS | CLADRIBINE. | CLADRIBINE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 127092851 | 12709285 | 3 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | 20 MG/M2, 2 IN 1 DAY | Y | 0 | 20 | MG/M**2 | BID | ||||||
| 127092851 | 12709285 | 4 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 100 MG, 1 IN 1 DAY | 0 | 100 | MG | TABLET | QD | ||||||
| 127092851 | 12709285 | 5 | C | AMIODARONE HYDROCHLORIDE. | AMIODARONE HYDROCHLORIDE | 1 | Oral | 200 MG, 1 IN 1 DAY | 0 | 200 | MG | TABLET | QD | ||||||
| 127092851 | 12709285 | 6 | C | AMIODARONE HYDROCHLORIDE. | AMIODARONE HYDROCHLORIDE | 1 | Oral | 400 MG, 2 IN 1 DAY | 0 | 400 | MG | TABLET | BID | ||||||
| 127092851 | 12709285 | 7 | C | AVODART | DUTASTERIDE | 1 | Oral | 0.5 MG, 1 IN 1 DAY | 0 | .5 | MG | CAPSULE | QD | ||||||
| 127092851 | 12709285 | 8 | C | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | Oral | 10 MG, 3 IN 1 DAY | 0 | 10 | MG | TABLET | TID | ||||||
| 127092851 | 12709285 | 9 | C | CYCLOBENZAPRINE HYDROCHLORIDE. | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | Oral | 5 MG, 1 IN 1 HOUR OF SLEEP | 0 | 5 | MG | TABLET | |||||||
| 127092851 | 12709285 | 10 | C | LUNESTA | ESZOPICLONE | 1 | Oral | 3 MG, 1 IN 1 HOUR OF SLEEP | 0 | 3 | MG | TABLET | |||||||
| 127092851 | 12709285 | 11 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Oral | 145 MG, 1 IN 1 DAY | 0 | 145 | MG | TABLET | QD | ||||||
| 127092851 | 12709285 | 12 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Unknown | 50 UG | 0 | ||||||||||
| 127092851 | 12709285 | 13 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG, 2 IN 1 DAY | 0 | 20 | MG | TABLET | BID | ||||||
| 127092851 | 12709285 | 14 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Topical | 2.5 %, 2 IN 1 DAY | 0 | CREAM | BID | ||||||||
| 127092851 | 12709285 | 15 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 500 MG, UNK | 0 | 500 | MG | TABLET | |||||||
| 127092851 | 12709285 | 16 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 127092851 | 12709285 | 17 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | Oral | 25 MG, 2 IN 1 DAY | 0 | 25 | MG | TABLET | BID | ||||||
| 127092851 | 12709285 | 18 | C | MENTHOL W/METHYL SALICYLATE | MENTHOLMETHYL SALICYLATE | 1 | Topical | 7-15% | 0 | ||||||||||
| 127092851 | 12709285 | 19 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | Oral | 50 MG, 2 IN 1 DAY | 0 | 50 | MG | TABLET | BID | ||||||
| 127092851 | 12709285 | 20 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, 1 IN 1 DAY | 0 | 20 | MG | CAPSULE | QD | ||||||
| 127092851 | 12709285 | 21 | C | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 4 MG, 1 IN 8 HOUR | 0 | 4 | MG | TABLET | |||||||
| 127092851 | 12709285 | 22 | C | PREDNISOLONE ACETATE. | PREDNISOLONE ACETATE | 1 | Ophthalmic | 1 %, IN 1 AS NECESSARY | 0 | ||||||||||
| 127092851 | 12709285 | 23 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, 1 IN 1 DAY | 0 | 5 | MG | TABLET | QD | ||||||
| 127092851 | 12709285 | 24 | C | TRIAMCINOLONE ACETONIDE. | TRIAMCINOLONE ACETONIDE | 1 | Topical | 0.1 %, 2 IN 1 DAY | 0 | ||||||||||
| 127092851 | 12709285 | 25 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 500 MG, UNK | 0 | 500 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127092851 | 12709285 | 1 | Acute myeloid leukaemia |
| 127092851 | 12709285 | 2 | Acute myeloid leukaemia |
| 127092851 | 12709285 | 3 | Acute myeloid leukaemia |
| 127092851 | 12709285 | 4 | Product used for unknown indication |
| 127092851 | 12709285 | 5 | Product used for unknown indication |
| 127092851 | 12709285 | 7 | Product used for unknown indication |
| 127092851 | 12709285 | 8 | Product used for unknown indication |
| 127092851 | 12709285 | 9 | Product used for unknown indication |
| 127092851 | 12709285 | 10 | Product used for unknown indication |
| 127092851 | 12709285 | 11 | Product used for unknown indication |
| 127092851 | 12709285 | 12 | Product used for unknown indication |
| 127092851 | 12709285 | 13 | Product used for unknown indication |
| 127092851 | 12709285 | 14 | Product used for unknown indication |
| 127092851 | 12709285 | 15 | Product used for unknown indication |
| 127092851 | 12709285 | 16 | Product used for unknown indication |
| 127092851 | 12709285 | 17 | Product used for unknown indication |
| 127092851 | 12709285 | 18 | Product used for unknown indication |
| 127092851 | 12709285 | 19 | Product used for unknown indication |
| 127092851 | 12709285 | 20 | Product used for unknown indication |
| 127092851 | 12709285 | 21 | Nausea |
| 127092851 | 12709285 | 22 | Product used for unknown indication |
| 127092851 | 12709285 | 23 | Product used for unknown indication |
| 127092851 | 12709285 | 24 | Rash pruritic |
| 127092851 | 12709285 | 25 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127092851 | 12709285 | HO |
| 127092851 | 12709285 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127092851 | 12709285 | Abdominal pain upper | |
| 127092851 | 12709285 | Arthralgia | |
| 127092851 | 12709285 | Arthritis | |
| 127092851 | 12709285 | Back pain | |
| 127092851 | 12709285 | Conjunctival haemorrhage | |
| 127092851 | 12709285 | Constipation | |
| 127092851 | 12709285 | Diarrhoea | |
| 127092851 | 12709285 | Dizziness | |
| 127092851 | 12709285 | Ear pain | |
| 127092851 | 12709285 | Ecchymosis | |
| 127092851 | 12709285 | Epistaxis | |
| 127092851 | 12709285 | Excessive cerumen production | |
| 127092851 | 12709285 | Fatigue | |
| 127092851 | 12709285 | Genitourinary operation | |
| 127092851 | 12709285 | Haemorrhoidal haemorrhage | |
| 127092851 | 12709285 | Heart rate irregular | |
| 127092851 | 12709285 | Musculoskeletal pain | |
| 127092851 | 12709285 | Nausea | |
| 127092851 | 12709285 | Neck pain | |
| 127092851 | 12709285 | Off label use | |
| 127092851 | 12709285 | Oropharyngeal pain | |
| 127092851 | 12709285 | Pancytopenia | |
| 127092851 | 12709285 | Product use issue | |
| 127092851 | 12709285 | Rash pruritic | |
| 127092851 | 12709285 | Rectal haemorrhage | |
| 127092851 | 12709285 | Skin plaque | |
| 127092851 | 12709285 | Urinary tract infection enterococcal | |
| 127092851 | 12709285 | Urine output 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 |
|---|---|---|---|---|---|---|
| 127092851 | 12709285 | 1 | 20140609 | 0 | ||
| 127092851 | 12709285 | 2 | 20150921 | 0 | ||
| 127092851 | 12709285 | 3 | 20150921 | 0 |