The Safety Rates Drug Report

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Drug     Injury     Quarter    

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
120470225 12047022 5 F 20140924 20160824 20160209 20160901 EXP JP-ROCHE-1492388 ROCHE IWASHIRO N, FUJIWARA AKI, AND DOMEN HIROMITSU A CASE OF BRAIN METASTASES AND LIVER METASTASES FROM POSTOPERATIVE ANAPLASTIC LYMPHOMA KINASE-POSITIVE LUNG CANCER WHERE ALECTINIB WAS EFFECTIVE AFTER THE EXPRESSION OF RESISTANCE TO CRIZOTINIB. JAPANESE JOURNAL OF LUNG CANCER/; ABSTRACTS OF THE 56TH ANNUAL MEETING OF THE JAPAN LUNG CANCER SOCIETY / THE 56TH ANNUAL MEETING OF THE JAPAN LUNG CANCER SOCIETY 2015 NOV;:658-. 74.19 YR F Y 44.00000 KG 20160901 MD JP JP

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
120470225 12047022 1 PS Alectinib ALECTINIB 1 Oral Y U 208434 600 MG CAPSULE QD
120470225 12047022 2 I Alectinib ALECTINIB 1 Oral Y U 208434 480 MG CAPSULE QD
120470225 12047022 3 I Alectinib ALECTINIB 1 Oral Y U 208434 320 MG CAPSULE QD
120470225 12047022 4 I Alectinib ALECTINIB 1 Oral Y U 208434 320 MG CAPSULE QD
120470225 12047022 5 I WARFARIN WARFARIN 1 Oral Y 0 1.5 MG QD
120470225 12047022 6 I WARFARIN WARFARIN 1 Y 0
120470225 12047022 7 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 10 MG TABLET QD
120470225 12047022 8 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 15 MG TABLET QD
120470225 12047022 9 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 20 MG TABLET QD
120470225 12047022 10 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 30 MG TABLET QD
120470225 12047022 11 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 40 MG TABLET QD
120470225 12047022 12 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 60 MG TABLET QD
120470225 12047022 13 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 90 MG TABLET QD
120470225 12047022 14 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 130 MG TABLET QD
120470225 12047022 15 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 120 MG TABLET QD
120470225 12047022 16 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 80 MG TABLET QD
120470225 12047022 17 I OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 0 40 MG TABLET QD
120470225 12047022 18 I OXINORM (JAPAN) OXYCODONE HYDROCHLORIDE 1 Oral TAKEN AS NEEDED 0 2.5 MG
120470225 12047022 19 I OXINORM (JAPAN) OXYCODONE HYDROCHLORIDE 1 Oral DOSAGE IS UNCERTAIN. 0 5 MG
120470225 12047022 20 I OXINORM (JAPAN) OXYCODONE HYDROCHLORIDE 1 Oral DOSAGE IS UNCERTAIN. 0 15 MG
120470225 12047022 21 I OXINORM (JAPAN) OXYCODONE HYDROCHLORIDE 1 Oral DOSAGE IS UNCERTAIN. 0 20 MG
120470225 12047022 22 I OXINORM (JAPAN) OXYCODONE HYDROCHLORIDE 1 Oral DOSAGE IS UNCERTAIN. 0 30 MG
120470225 12047022 23 I OXINORM (JAPAN) OXYCODONE HYDROCHLORIDE 1 Oral DOSAGE DURING A DAY: 30MG-40MG?TAKEN FOR PAIN 0
120470225 12047022 24 SS ALIMTA PEMETREXED DISODIUM 1 Intravenous drip 0 500 MG Q3W
120470225 12047022 25 SS ALIMTA PEMETREXED DISODIUM 1 Intravenous drip 0 500 MG Q3W
120470225 12047022 26 C MOHRUS TAPE L 2 Topical AT THE PAIN 0 40 MG
120470225 12047022 27 C PRIMPERAN METOCLOPRAMIDE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 0 10 MG QD
120470225 12047022 28 C PRIMPERAN METOCLOPRAMIDE HYDROCHLORIDE 1 Oral DOSAGE DURING A DAY: 5-10MG THE FRACTIONATION DOSE FREQUENCY IS UNCERTAIN. 0
120470225 12047022 29 C GLYCEOL GLYCERIN 1 Intravenous (not otherwise specified) 0 200 ML QD
120470225 12047022 30 C MARZULENE-S SODIUM GUALENATE 1 Oral 0 1 G QD
120470225 12047022 31 C PANTOSIN PANTETHINE 1 Oral 0 2 G QD
120470225 12047022 32 C CELECOX CELECOXIB 1 Oral 0 400 MG QD
120470225 12047022 33 C CELECOX CELECOXIB 1 Oral DOSAGE DURING A DAY: 200MG- 100MG THE FRACTIONATION DOSE FREQUENCY IS UNCERATIN. 0
120470225 12047022 34 C PURSENNID SENNOSIDES A AND B 1 Oral TAKEN FOR CONSTIPATION 0 24 MG QD
120470225 12047022 35 C CALONAL ACETAMINOPHEN 1 Oral 0 300 MG QD
120470225 12047022 36 C DONEPEZIL HYDROCHLORIDE. DONEPEZIL HYDROCHLORIDE 1 Oral 0 5 MG QD
120470225 12047022 37 C Flunitrazepam FLUNITRAZEPAM 1 Oral 0 2 MG QD
120470225 12047022 38 C Flunitrazepam FLUNITRAZEPAM 1 Oral TAKEN FOR INSOMNIA 0 1 MG
120470225 12047022 39 C SENNOSIDE SENNOSIDES 1 Oral DOSAGE DURING A DAY: 48 (UNIT UNCERTAINTY)?TAKEN FOR CONSTIPATION 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
120470225 12047022 1 Lung adenocarcinoma
120470225 12047022 2 Lung adenocarcinoma
120470225 12047022 3 Lung adenocarcinoma
120470225 12047022 4 Lung adenocarcinoma
120470225 12047022 5 Product used for unknown indication
120470225 12047022 6 Lung adenocarcinoma
120470225 12047022 7 Lung adenocarcinoma
120470225 12047022 8 Lung adenocarcinoma
120470225 12047022 9 Lung adenocarcinoma
120470225 12047022 10 Lung adenocarcinoma
120470225 12047022 11 Lung adenocarcinoma
120470225 12047022 12 Lung adenocarcinoma
120470225 12047022 13 Lung adenocarcinoma
120470225 12047022 14 Lung adenocarcinoma
120470225 12047022 15 Lung adenocarcinoma
120470225 12047022 16 Lung adenocarcinoma
120470225 12047022 17 Lung adenocarcinoma
120470225 12047022 18 Lung adenocarcinoma
120470225 12047022 19 Lung adenocarcinoma
120470225 12047022 20 Lung adenocarcinoma
120470225 12047022 21 Lung adenocarcinoma
120470225 12047022 22 Lung adenocarcinoma
120470225 12047022 23 Lung adenocarcinoma
120470225 12047022 24 Lung adenocarcinoma
120470225 12047022 25 Lung adenocarcinoma
120470225 12047022 26 Lung adenocarcinoma
120470225 12047022 27 Lung adenocarcinoma
120470225 12047022 29 Lung adenocarcinoma
120470225 12047022 30 Gastritis
120470225 12047022 31 Gastritis
120470225 12047022 32 Lung adenocarcinoma
120470225 12047022 33 Lung adenocarcinoma
120470225 12047022 35 Lung adenocarcinoma

Outcome of event

Event ID CASEID OUTC COD
120470225 12047022 HO
120470225 12047022 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
120470225 12047022 Anaemia
120470225 12047022 Blood bilirubin increased
120470225 12047022 Blood creatinine increased
120470225 12047022 Blood urea increased
120470225 12047022 Cell marker increased
120470225 12047022 Constipation
120470225 12047022 Decreased appetite
120470225 12047022 Diarrhoea
120470225 12047022 Drug interaction
120470225 12047022 Dry eye
120470225 12047022 Dry skin
120470225 12047022 Hyperkalaemia
120470225 12047022 Hypocalcaemia
120470225 12047022 Hypochloraemia
120470225 12047022 Hypokalaemia
120470225 12047022 Influenza
120470225 12047022 International normalised ratio increased
120470225 12047022 Interstitial lung disease
120470225 12047022 Neutropenia
120470225 12047022 Oedema peripheral
120470225 12047022 Pyrexia
120470225 12047022 Rash
120470225 12047022 Somnolence
120470225 12047022 Stomatitis
120470225 12047022 Vomiting
120470225 12047022 White blood cell count 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
120470225 12047022 1 20140918 20141010 0
120470225 12047022 2 20141011 20141024 0
120470225 12047022 3 20141031 20141228 0
120470225 12047022 4 20150117 0
120470225 12047022 5 20141229 0
120470225 12047022 7 20140816 20140911 0
120470225 12047022 8 20140912 20140916 0
120470225 12047022 9 20140917 20141019 0
120470225 12047022 10 20141020 20141106 0
120470225 12047022 11 20141107 20141115 0
120470225 12047022 12 20141116 20141214 0
120470225 12047022 13 20141215 20141228 0
120470225 12047022 14 20141229 20150119 0
120470225 12047022 15 20150120 20150206 0
120470225 12047022 16 20150207 20150218 0
120470225 12047022 17 20150219 20150219 0
120470225 12047022 18 20141106 0
120470225 12047022 19 20141107 20141218 0
120470225 12047022 20 20141219 20150206 0
120470225 12047022 21 20150207 20150310 0
120470225 12047022 22 20150311 0
120470225 12047022 24 20160129 20160129 0
120470225 12047022 25 20160219 20160311 0
120470225 12047022 27 20140909 20141009 0
120470225 12047022 28 20150311 0
120470225 12047022 29 20140917 20140930 0
120470225 12047022 30 20150302 0
120470225 12047022 31 20150302 0
120470225 12047022 33 20150505 0
120470225 12047022 35 20140925 0
120470225 12047022 36 20150225 0
120470225 12047022 38 20150416 20150610 0