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
119838887 11983888 7 F 20151219 20160905 20160201 20160913 EXP JP-TAKEDA-2016MPI000518 TAKEDA 89.10 YR M Y 53.00000 KG 20160913 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
119838887 11983888 1 PS VELCADE BORTEZOMIB 1 Subcutaneous 1.6 MG, 2/WEEK Y 064API;066CPI 21602 1.6 MG INJECTION BIW
119838887 11983888 2 SS VELCADE BORTEZOMIB 1 Subcutaneous 1 MG, UNK Y 064API;066CPI 21602 1 MG INJECTION
119838887 11983888 3 SS VELCADE BORTEZOMIB 1 Subcutaneous UNK Y 064API;066CPI 21602 INJECTION
119838887 11983888 4 SS PREDNISOLONE. PREDNISOLONE 1 Oral 95 MG, QD 285 MG Y 0 95 MG QD
119838887 11983888 5 SS DARATUMUMAB DARATUMUMAB 1 Intravenous (not otherwise specified) 880 MG, Q3WEEKS Y 4371280 0 880 MG INJECTION Q3W
119838887 11983888 6 SS MELPHALAN MELPHALAN 1 Oral 14 MG, QD 56 MG Y 0 14 MG QD
119838887 11983888 7 C TELEMINSOFT BISACODYL 1 Rectal 10 MG, UNK 0 10 MG SUPPOSITORY
119838887 11983888 8 C TELEMINSOFT BISACODYL 1 Rectal 10 MG, UNK 0 10 MG SUPPOSITORY
119838887 11983888 9 C LIMAPROST ALFADEX LIMAPROST 1 Oral 5 MG, TID 630 MG 0 5 MG TID
119838887 11983888 10 C RIBOFLAVIN RIBOFLAVIN 1 Oral 2.5 MG, TID 0 2.5 MG TID
119838887 11983888 11 C LANDSEN CLONAZEPAM 1 Oral 0.2 MG, BID 14.3999996 MG 0 .2 MG BID
119838887 11983888 12 C LANDSEN CLONAZEPAM 1 Oral 0.2 MG, BID 14.3999996 MG 0 .2 MG BID
119838887 11983888 13 C DAIKENCHUTO HERBALS 1 Oral 2.5 G, UNK 0 2.5 G
119838887 11983888 14 C DAIKENCHUTO HERBALS 1 Oral 2.5 G, UNK 0 2.5 G
119838887 11983888 15 C TRAMADOL HYDROCHLORIDE. TRAMADOL HYDROCHLORIDE 1 Oral 3.75 MG, TID 0 3.75 MG TID
119838887 11983888 16 C ACETAMINOPHEN. ACETAMINOPHEN 1 Oral 325 MG, TID 0 325 MG TID
119838887 11983888 17 C ACETAMINOPHEN. ACETAMINOPHEN 1 0
119838887 11983888 18 C BONOTEO MINODRONIC ACID 1 Oral 50 MG, MONTHLY 0 50 MG TABLET /month
119838887 11983888 19 C URIMOX 2 Topical UNK 0 CREAM
119838887 11983888 20 C VITAMINS NOS VITAMINS 1 Oral 5 MG, TID 0 5 MG TID
119838887 11983888 21 C XYLOCAINE LIDOCAINE HYDROCHLORIDE 1 Topical UNK 0
119838887 11983888 22 C PYRIDOXINE HYDROCHLORIDE. PYRIDOXINE HYDROCHLORIDE 1 Oral 40 MG, TID 0 40 MG TID
119838887 11983888 23 C CYANOCOBALAMIN. CYANOCOBALAMIN 1 Oral 0.25 MG, TID 0 .25 MG TID
119838887 11983888 24 C BIOFERMIN /07958301/ 2 Oral UNK, TID 0 TID
119838887 11983888 25 C BIOFERMIN /07958301/ 2 0
119838887 11983888 26 C PURSENNID /00571902/ SENNOSIDES A AND B 1 Oral 24 MG, UNK 0 24 MG
119838887 11983888 27 C OCTOTIAMINE OCTOTIAMINE 1 Oral 25 MG, TID 0 25 MG TID
119838887 11983888 28 C SODIUM GUALENATE SODIUM GUALENATE 1 Unknown UNK 0 ORAL LIQUID
119838887 11983888 29 C ZOFRAN ONDANSETRON HYDROCHLORIDE 1 Oral 4 MG, UNK 0 4 MG
119838887 11983888 30 C CALONAL ACETAMINOPHEN 1 Oral 400 MG, UNK 0 400 MG TABLET
119838887 11983888 31 C CALONAL ACETAMINOPHEN 1 Oral 400 MG, UNK 0 400 MG TABLET
119838887 11983888 32 C CALONAL ACETAMINOPHEN 1 Oral 400 MG, UNK 0 400 MG TABLET
119838887 11983888 33 C CALONAL ACETAMINOPHEN 1 0 TABLET
119838887 11983888 34 C CALONAL ACETAMINOPHEN 1 0 TABLET
119838887 11983888 35 C CALONAL ACETAMINOPHEN 1 0 TABLET
119838887 11983888 36 C CALONAL ACETAMINOPHEN 1 0 TABLET
119838887 11983888 37 C CALONAL ACETAMINOPHEN 1 0 TABLET
119838887 11983888 38 C NAUZELIN DOMPERIDONE 1 Oral 0.5 G, BID 0 .5 G GRANULE BID
119838887 11983888 39 C FEBURIC FEBUXOSTAT 1 Oral 40 MG, QD 0 40 MG TABLET QD
119838887 11983888 40 C MOHRUS KETOPROFEN 1 Topical 40 MG, UNK 0 40 MG
119838887 11983888 41 C BFLUID AMINO ACIDSDEXTROSEELECTROLYTES NOSVITAMINS 1 Intravenous (not otherwise specified) 1000 ML, QD 4500 ML 0 1000 ML INJECTION QD
119838887 11983888 42 C BFLUID AMINO ACIDSDEXTROSEELECTROLYTES NOSVITAMINS 1 Intravenous (not otherwise specified) 500 ML, QD 4500 ML 0 500 ML INJECTION QD
119838887 11983888 43 C BFLUID AMINO ACIDSDEXTROSEELECTROLYTES NOSVITAMINS 1 Intravenous (not otherwise specified) 1000 ML, QD 4500 ML 0 1000 ML INJECTION QD
119838887 11983888 44 C BFLUID AMINO ACIDSDEXTROSEELECTROLYTES NOSVITAMINS 1 Intravenous (not otherwise specified) 1000 ML, QD 4500 ML 0 1000 ML INJECTION QD
119838887 11983888 45 C SULFAMETHOXAZOLE SULFAMETHOXAZOLE 1 Oral 400 MG, QD 11600 MG 0 400 MG QD
119838887 11983888 46 C VITAMEDIN INTRAVENOUS CYANOCOBALAMINPYRIDOXINE HYDROCHLORIDETHIAMINE 1 Intravenous (not otherwise specified) UNK, QD 0 INJECTION QD
119838887 11983888 47 C VITAMEDIN INTRAVENOUS CYANOCOBALAMINPYRIDOXINE HYDROCHLORIDETHIAMINE 1 Intravenous (not otherwise specified) UNK, QD 0 INJECTION QD
119838887 11983888 48 C VITAMEDIN INTRAVENOUS CYANOCOBALAMINPYRIDOXINE HYDROCHLORIDETHIAMINE 1 Intravenous (not otherwise specified) UNK, QD 0 INJECTION QD
119838887 11983888 49 C VITAMEDIN INTRAVENOUS CYANOCOBALAMINPYRIDOXINE HYDROCHLORIDETHIAMINE 1 Intravenous (not otherwise specified) UNK, QD 0 INJECTION QD
119838887 11983888 50 C LACTEC D /00895301/ 2 Intravenous (not otherwise specified) 500 ML, QD 1000 ML 0 500 ML QD
119838887 11983888 51 C LACTEC D /00895301/ 2 Intravenous (not otherwise specified) 500 ML, QD 1000 ML 0 500 ML QD
119838887 11983888 52 C LACTEC D /00895301/ 2 Intravenous (not otherwise specified) 500 ML, UNK 1000 ML 0 500 ML
119838887 11983888 53 C CLOSTRIDIUM BUTYRICUM CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 1 Unknown UNK 0
119838887 11983888 54 C ZOVIRAX ACYCLOVIR 1 Oral 200 MG, QD 5800 MG 0 200 MG QD
119838887 11983888 55 C ZOVIRAX ACYCLOVIR 1 Oral 200 MG, QD 5800 MG 0 200 MG QD
119838887 11983888 56 C PERAPRIN METOCLOPRAMIDE 1 Oral 5 MG, UNK 0 5 MG
119838887 11983888 57 C PROMETHAZINE METHYLENE DISALICYLATE 2 Oral 13.5 MG, TID 121.5 MG 0 13.5 MG TID
119838887 11983888 58 C NORMAL SALINE SODIUM CHLORIDE 1 Unknown UNK 0
119838887 11983888 59 C CAFEINE CAFFEINE 1 Unknown UNK 0
119838887 11983888 60 C LOXONIN LOXOPROFEN SODIUM 1 Oral 60 MG, UNK 0 60 MG
119838887 11983888 61 C ELNEOPA NO.1 2 Intravenous (not otherwise specified) 1500 ML, QD 4500 ML 0 1500 ML INJECTION QD
119838887 11983888 62 C ELNEOPA NO.1 2 Intravenous (not otherwise specified) 1500 ML, QD 4500 ML 0 1500 ML INJECTION QD
119838887 11983888 63 C DENOSIN 2 Unknown 500 MG, UNK 0 500 MG INTRAVENOUS INFUSION
119838887 11983888 64 C MAGMITT MAGNESIUM OXIDE 1 Oral 330 MG, UNK 0 330 MG TABLET
119838887 11983888 65 C LOPERAMIDE /00384302/ 2 Oral 1 MG, BID 6 MG 0 1 MG BID
119838887 11983888 66 C LOPERAMIDE /00384302/ 2 Oral 1 MG, UNK 6 MG 0 1 MG
119838887 11983888 67 C LOPERAMIDE /00384302/ 2 Oral 1 MG, BID 6 MG 0 1 MG BID
119838887 11983888 68 C K-SUPPLY POTASSIUM CHLORIDE 1 Oral 600 MG, BID 9600 MG 0 600 MG TABLET BID
119838887 11983888 69 C CHLORHEXIDINE GLUCONATE. CHLORHEXIDINE GLUCONATE 1 Topical UNK 0
119838887 11983888 70 C CHLORHEXIDINE GLUCONATE. CHLORHEXIDINE GLUCONATE 1 Topical UNK 0
119838887 11983888 71 C SALICYLAMIDE SALICYLAMIDE 1 Oral 270 MG, TID 2430 MG 0 270 MG TID
119838887 11983888 72 C SOLYUGEN F 2 Intravenous (not otherwise specified) 500 ML, UNK 0 500 ML INJECTION
119838887 11983888 73 C STREPTOCOCCUS FAECALIS STREPTOCOCCUS FAECALIS 1 Unknown UNK 0
119838887 11983888 74 C TRIMETHOPRIM. TRIMETHOPRIM 1 Oral 80 MG, QD 2320 MG 0 80 MG QD
119838887 11983888 75 C PLATELETS HUMAN PLATELET, ALLOGENIC 1 Unknown UNK 0
119838887 11983888 76 C SODIUM CHLORIDE. SODIUM CHLORIDE 1 Intravenous (not otherwise specified) 500 ML, BID 3000 ML 0 500 ML BID
119838887 11983888 77 C SODIUM CHLORIDE. SODIUM CHLORIDE 1 Intravenous (not otherwise specified) 4 MG, QD 3000 ML 0 4 MG QD
119838887 11983888 78 C SODIUM CHLORIDE. SODIUM CHLORIDE 1 Intravenous (not otherwise specified) 2 MG, QD 3000 ML 0 2 MG QD
119838887 11983888 79 C SODIUM CHLORIDE. SODIUM CHLORIDE 1 Unknown UNK 3000 ML 0
119838887 11983888 80 C FUROSEMIDE. FUROSEMIDE 1 Intravenous (not otherwise specified) 20 MG, QD 0 20 MG INJECTION QD
119838887 11983888 81 C FUROSEMIDE. FUROSEMIDE 1 Intravenous (not otherwise specified) 20 MG, QD 0 20 MG INJECTION QD
119838887 11983888 82 C ELNEOPA NO.2 AMINO ACIDSCARBOHYDRATESELECTROLYTES NOSVITAMINS 1 Unknown UNK 0 INJECTION
119838887 11983888 83 C BROTIZOLAM BROTIZOLAM 1 Oral 0.25 MG, UNK 0 .25 MG
119838887 11983888 84 C RAPIACTA PERAMIVIR 1 Unknown UNK 0
119838887 11983888 85 C LEVOFLOXACIN. LEVOFLOXACIN 1 Unknown UNK 0
119838887 11983888 86 C SENNOSIDE /00571902/ SENNOSIDES A AND B 1 Oral 12 MG, UNK 0 12 MG
119838887 11983888 87 C ANHYDROUS CAFFEINE CAFFEINE 1 Oral 60 MG, TID 540 MG 0 60 MG TID
119838887 11983888 88 C GANCICLOVIR. GANCICLOVIR 1 Intravenous (not otherwise specified) 250 MG, BID 0 250 MG BID
119838887 11983888 89 C KETOPROFEN. KETOPROFEN 1 Topical 40 MG, UNK 0 40 MG
119838887 11983888 90 C VALIXA VALGANCICLOVIR 1 Oral 450 MG, QD 0 450 MG QD
119838887 11983888 91 C ACETAMINOPHEN. ACETAMINOPHEN 1 Oral 150 MG, TID 1350 MG U 0 150 MG TID
119838887 11983888 92 C SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral UNK, QD 0 QD
119838887 11983888 93 C RINDERON VG BETAMETHASONE VALERATEGENTAMICIN SULFATE 1 Topical UNK 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
119838887 11983888 1 Plasma cell myeloma
119838887 11983888 4 Plasma cell myeloma
119838887 11983888 5 Plasma cell myeloma
119838887 11983888 6 Plasma cell myeloma
119838887 11983888 7 Constipation
119838887 11983888 9 Lumbar spinal stenosis
119838887 11983888 10 Lumbar spinal stenosis
119838887 11983888 11 Essential tremor
119838887 11983888 13 Constipation
119838887 11983888 15 Spinal compression fracture
119838887 11983888 16 Nasopharyngitis
119838887 11983888 17 Spinal compression fracture
119838887 11983888 18 Osteoporosis
119838887 11983888 19 Dry skin
119838887 11983888 20 Lumbar spinal stenosis
119838887 11983888 21 Central venous catheterisation
119838887 11983888 22 Lumbar spinal stenosis
119838887 11983888 23 Lumbar spinal stenosis
119838887 11983888 24 Prophylaxis
119838887 11983888 25 Enterocolitis
119838887 11983888 26 Constipation
119838887 11983888 27 Lumbar spinal stenosis
119838887 11983888 28 Infection prophylaxis
119838887 11983888 29 Prophylaxis of nausea and vomiting
119838887 11983888 30 Nasopharyngitis
119838887 11983888 31 Bronchitis
119838887 11983888 32 Influenza
119838887 11983888 33 Spinal compression fracture
119838887 11983888 34 Urinary tract infection
119838887 11983888 35 Cytomegalovirus infection
119838887 11983888 36 Incision site pain
119838887 11983888 37 Pyrexia
119838887 11983888 38 Prophylaxis of nausea and vomiting
119838887 11983888 39 Hyperuricaemia
119838887 11983888 40 Spinal compression fracture
119838887 11983888 41 Prophylaxis against dehydration
119838887 11983888 42 Decreased appetite
119838887 11983888 43 Diarrhoea
119838887 11983888 44 Malnutrition
119838887 11983888 45 Antifungal prophylaxis
119838887 11983888 46 Prophylaxis against dehydration
119838887 11983888 47 Diarrhoea
119838887 11983888 48 Malnutrition
119838887 11983888 49 Decreased appetite
119838887 11983888 50 Decreased appetite
119838887 11983888 51 Diarrhoea
119838887 11983888 52 Orthostatic intolerance
119838887 11983888 53 Diarrhoea
119838887 11983888 54 Antiviral prophylaxis
119838887 11983888 56 Nausea
119838887 11983888 57 Nasopharyngitis
119838887 11983888 58 Loss of consciousness
119838887 11983888 59 Nasopharyngitis
119838887 11983888 60 Abdominal tenderness
119838887 11983888 61 Decreased appetite
119838887 11983888 63 Cytomegalovirus infection
119838887 11983888 64 Constipation
119838887 11983888 65 Antidiarrhoeal supportive care
119838887 11983888 68 Hypokalaemia
119838887 11983888 69 Skin erosion
119838887 11983888 70 Skin abrasion
119838887 11983888 71 Nasopharyngitis
119838887 11983888 72 Diarrhoea
119838887 11983888 73 Diarrhoea
119838887 11983888 74 Antifungal prophylaxis
119838887 11983888 75 Thrombocytopenia
119838887 11983888 76 Hyponatraemia
119838887 11983888 77 Loss of consciousness
119838887 11983888 80 Pleural effusion
119838887 11983888 82 Decreased appetite
119838887 11983888 83 Insomnia
119838887 11983888 84 Influenza
119838887 11983888 85 Urinary tract infection
119838887 11983888 86 Constipation
119838887 11983888 87 Nasopharyngitis
119838887 11983888 88 Cytomegalovirus infection
119838887 11983888 89 Lumbar spinal stenosis
119838887 11983888 90 Antiviral prophylaxis
119838887 11983888 91 Nasopharyngitis
119838887 11983888 92 Antifungal prophylaxis
119838887 11983888 93 Herpes zoster disseminated

Outcome of event

Event ID CASEID OUTC COD
119838887 11983888 OT
119838887 11983888 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
119838887 11983888 Abdominal tenderness
119838887 11983888 Cytomegalovirus infection
119838887 11983888 Decreased appetite
119838887 11983888 Diarrhoea
119838887 11983888 Herpes zoster
119838887 11983888 Hypokalaemia
119838887 11983888 Hyponatraemia
119838887 11983888 Incision site pain
119838887 11983888 Influenza
119838887 11983888 Insomnia
119838887 11983888 Loss of consciousness
119838887 11983888 Nausea
119838887 11983888 Orthostatic intolerance
119838887 11983888 Pleural effusion
119838887 11983888 Pyrexia
119838887 11983888 Skin abrasion
119838887 11983888 Skin erosion
119838887 11983888 Thrombocytopenia
119838887 11983888 Urinary tract infection

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
119838887 11983888 1 20151215 0
119838887 11983888 2 20160105 0
119838887 11983888 3 20160222 0
119838887 11983888 4 20151216 20151218 0
119838887 11983888 5 20151215 20160215 0
119838887 11983888 6 20151215 20151218 0
119838887 11983888 7 20151208 20151208 0
119838887 11983888 8 20160102 20160107 0
119838887 11983888 9 20151208 20160121 0
119838887 11983888 10 20160121 0
119838887 11983888 11 20151210 0
119838887 11983888 12 20151211 20160115 0
119838887 11983888 13 20151218 0
119838887 11983888 14 20160102 20160121 0
119838887 11983888 15 20160115 0
119838887 11983888 16 20160115 0
119838887 11983888 18 20151127 0
119838887 11983888 19 20151202 0
119838887 11983888 20 20151207 0
119838887 11983888 21 20160115 20160115 0
119838887 11983888 22 20160121 0
119838887 11983888 23 20160121 0
119838887 11983888 24 20151208 0
119838887 11983888 26 20151218 0
119838887 11983888 27 20160121 0
119838887 11983888 28 20151216 0
119838887 11983888 29 20151215 0
119838887 11983888 30 20160108 20160122 0
119838887 11983888 31 20160219 20160219 0
119838887 11983888 32 20160220 20160311 0
119838887 11983888 38 20151208 0
119838887 11983888 39 20160115 0
119838887 11983888 40 20151228 0
119838887 11983888 41 20151221 20151221 0
119838887 11983888 42 20151223 20151223 0
119838887 11983888 43 20160111 20160111 0
119838887 11983888 44 20160113 20160114 0
119838887 11983888 45 20151221 20160409 0
119838887 11983888 46 20151221 20151221 0
119838887 11983888 47 20151223 20151223 0
119838887 11983888 48 20160111 20160111 0
119838887 11983888 49 20160113 20160114 0
119838887 11983888 50 20151224 20151224 0
119838887 11983888 51 20160112 20160112 0
119838887 11983888 52 20160414 20160414 0
119838887 11983888 54 20151221 20160215 0
119838887 11983888 55 20160531 0
119838887 11983888 56 20151221 20151221 0
119838887 11983888 57 20160109 20160111 0
119838887 11983888 60 20160111 20160111 0
119838887 11983888 61 20160115 20160117 0
119838887 11983888 62 20160118 20160131 0
119838887 11983888 64 20160104 0
119838887 11983888 65 20151225 20151227 0
119838887 11983888 66 20160105 20160109 0
119838887 11983888 67 20160215 20160217 0
119838887 11983888 68 20160105 20160112 0
119838887 11983888 69 20160328 0
119838887 11983888 70 20160106 20160109 0
119838887 11983888 71 20160109 20160111 0
119838887 11983888 72 20151220 20151220 0
119838887 11983888 74 20151221 20160409 0
119838887 11983888 76 20160101 20160103 0
119838887 11983888 77 20160118 20160124 0
119838887 11983888 78 20160125 20160127 0
119838887 11983888 80 20160125 20160127 0
119838887 11983888 81 20160121 20160123 0
119838887 11983888 83 20160124 20160224 0
119838887 11983888 86 20151230 20160102 0
119838887 11983888 87 20160109 20160111 0
119838887 11983888 88 20160118 20160127 0
119838887 11983888 89 20160206 0
119838887 11983888 90 20160216 20160409 0
119838887 11983888 91 20160109 20160111 0
119838887 11983888 92 20160418 0
119838887 11983888 93 20160514 20160514 0