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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125947732 | 12594773 | 2 | F | 20160427 | 20160809 | 20160726 | 20160816 | EXP | RO-TAKEDA-2016MPI003892AA | TAKEDA | 72.00 | YR | M | Y | 74.00000 | KG | 20160816 | MD | RO | RO |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125947732 | 12594773 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.9 MG, UNK | Y | 4371089 | 21602 | 1.9 | MG | INJECTION | |||||
125947732 | 12594773 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1 MG/M2, UNK | Y | 4371089 | 21602 | 1 | MG/M**2 | INJECTION | |||||
125947732 | 12594773 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 60 MG/M2, UNK | 0 | 60 | MG/M**2 | ||||||||
125947732 | 12594773 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 20 MG, UNK | U | 1600064 | 0 | 20 | MG | ||||||
125947732 | 12594773 | 5 | SS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | 3583.33301 | MG | 0 | 5 | MG | QD | |||||
125947732 | 12594773 | 6 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 16 MG/KG, UNK | Y | 4371374;4370774;FDTK00L | 0 | 16 | MG/KG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
125947732 | 12594773 | 7 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 9 MG/M2, UNK | 4371504 | 0 | 9 | MG/M**2 | |||||||
125947732 | 12594773 | 8 | SS | PERINDOPRIL | PERINDOPRIL | 1 | Oral | 10 MG, QD | 7160 | MG | 0 | 10 | MG | TABLET | QD | ||||
125947732 | 12594773 | 9 | SS | CORYOL /00984501/ | CARVEDILOL | 1 | Oral | 6.25 MG, BID | 8949.50098 | MG | 0 | 6.25 | MG | TABLET | BID | ||||
125947732 | 12594773 | 10 | C | INDAPAMID | INDAPAMIDE | 1 | Oral | 1.5 MG, QD | 1075 | MG | 0 | 1.5 | MG | TABLET | QD | ||||
125947732 | 12594773 | 11 | C | INDAPAMID | INDAPAMIDE | 1 | Oral | 1.5 MG, UNK | 1075 | MG | 0 | 1.5 | MG | TABLET | |||||
125947732 | 12594773 | 12 | C | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 110 MG, BID | 157666.672 | MG | 0 | 110 | MG | TABLET | BID | ||||
125947732 | 12594773 | 13 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 50 MG, BID | 0 | 50 | MG | TABLET | BID | ||||||
125947732 | 12594773 | 14 | C | ACICLOVIR | ACYCLOVIR | 1 | Oral | 400 MG, BID | 0 | 400 | MG | TABLET | BID | ||||||
125947732 | 12594773 | 15 | C | ZOLEDRONIC ACID. | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, UNK | 0 | 4 | MG | ||||||||
125947732 | 12594773 | 16 | C | QUAMATEL | FAMOTIDINE | 1 | Intravenous (not otherwise specified) | 20 MG, UNK | 0 | 20 | MG | ||||||||
125947732 | 12594773 | 17 | C | OMEZ /00661201/ | OMEPRAZOLE | 1 | Oral | 20 MG, QD | 60 | MG | 0 | 20 | MG | TABLET | QD | ||||
125947732 | 12594773 | 18 | C | ERYTHROPOIETIN | ERYTHROPOIETIN | 1 | Subcutaneous | 40000 IU, UNK | 0 | 40000 | IU | INJECTION | |||||||
125947732 | 12594773 | 19 | C | MILURIT | ALLOPURINOL | 1 | Unknown | 300 MG, UNK | 0 | 300 | MG | ||||||||
125947732 | 12594773 | 20 | C | MILURIT | ALLOPURINOL | 1 | Unknown | 300 UNK, UNK | 0 | 300 | MG | ||||||||
125947732 | 12594773 | 21 | C | MOXIFLOXACIN. | MOXIFLOXACIN | 1 | Oral | 400 MG, UNK | 0 | 400 | MG | TABLET | |||||||
125947732 | 12594773 | 22 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | 6.25 MG, UNK | 0 | 6.25 | MG | TABLET | |||||||
125947732 | 12594773 | 23 | C | FUROSEMIDE W/SPIRONOLACTONE | FUROSEMIDESPIRONOLACTONE | 1 | Oral | UNK | 0 | TABLET | |||||||||
125947732 | 12594773 | 24 | C | FILGRASTIM | FILGRASTIM | 1 | Subcutaneous | 300 ?G, UNK | 0 | 300 | UG | INJECTION | |||||||
125947732 | 12594773 | 25 | C | ALBUMIN | ALBUMIN HUMAN | 1 | Intravenous (not otherwise specified) | 200 G, UNK | 0 | 200 | G | ORAL SUSPENSION | |||||||
125947732 | 12594773 | 26 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Respiratory (inhalation) | 8 MG, BID | 0 | 8 | MG | INJECTION | BID | ||||||
125947732 | 12594773 | 27 | C | FRAXIPARINA | NADROPARIN CALCIUM | 1 | Subcutaneous | 5700 IU, UNK | 0 | 5700 | IU | INJECTION | |||||||
125947732 | 12594773 | 28 | C | FRAXIPARINA | NADROPARIN CALCIUM | 1 | Subcutaneous | 2850 IU, UNK | 0 | 2850 | IU | INJECTION | |||||||
125947732 | 12594773 | 29 | C | FRAXIPARINA | NADROPARIN CALCIUM | 1 | Subcutaneous | 5700 IU, UNK | 0 | 5700 | IU | INJECTION | |||||||
125947732 | 12594773 | 30 | C | LORATADINA | LORATADINE | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | TABLET | |||||||
125947732 | 12594773 | 31 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | TABLET | |||||||
125947732 | 12594773 | 32 | C | ACETILCISTEINA | ACETYLCYSTEINE | 1 | Respiratory (inhalation) | 300 MG, BID | 0 | 300 | MG | INJECTION | BID | ||||||
125947732 | 12594773 | 33 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Oral | 50 MG, BID | 0 | 50 | MG | BID | |||||||
125947732 | 12594773 | 34 | C | FLUCONAZOL | FLUCONAZOLE | 1 | Oral | 150 MG, BID | 0 | 150 | MG | TABLET | BID | ||||||
125947732 | 12594773 | 35 | C | AMIKACIN | AMIKACIN | 1 | Intravenous (not otherwise specified) | 500 MG, BID | 0 | 500 | MG | BID | |||||||
125947732 | 12594773 | 36 | C | TAZOCIN | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 4500 MG, QID | 0 | 4500 | MG | QID | |||||||
125947732 | 12594773 | 37 | C | MERONEM | MEROPENEM | 1 | Intravenous (not otherwise specified) | 1000 MG, TID | 0 | 1000 | MG | INJECTION | TID | ||||||
125947732 | 12594773 | 38 | C | MOXIFLOXACIN. | MOXIFLOXACIN | 1 | Intravenous (not otherwise specified) | 400 MG, UNK | 0 | 400 | MG | INJECTION | |||||||
125947732 | 12594773 | 39 | C | CIPRINOL /00697202/ | 2 | Intravenous (not otherwise specified) | 300 MG, BID | 0 | 300 | MG | BID | ||||||||
125947732 | 12594773 | 40 | C | CEFOPERAZONE W/SULBACTAM | CEFOPERAZONESULBACTAM | 1 | Intravenous (not otherwise specified) | 2000 MG, BID | 0 | 2000 | MG | BID | |||||||
125947732 | 12594773 | 41 | C | HYDROGEN PEROXIDE BELL | 2 | Topical | 50 ML, TID | 0 | 50 | ML | ORAL LIQUID | TID | |||||||
125947732 | 12594773 | 42 | C | CALCIUM GLUCONATE. | CALCIUM GLUCONATE | 1 | Intravenous (not otherwise specified) | 940 MG, BID | 0 | 940 | MG | INJECTION | BID | ||||||
125947732 | 12594773 | 43 | C | FITOMENADIONA | 2 | Intravenous (not otherwise specified) | 20 MG, BID | 0 | 20 | MG | INJECTION | BID | |||||||
125947732 | 12594773 | 44 | C | ETAMSILAT | 2 | Intravenous (not otherwise specified) | 1000 MG, BID | 0 | 1000 | MG | INJECTION | BID | |||||||
125947732 | 12594773 | 45 | C | MIDODRINE | MIDODRINE | 1 | Oral | 2.5 MG, TID | 0 | 2.5 | MG | TABLET | TID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125947732 | 12594773 | 1 | Plasma cell myeloma |
125947732 | 12594773 | 3 | Plasma cell myeloma |
125947732 | 12594773 | 4 | Plasma cell myeloma |
125947732 | 12594773 | 5 | Essential hypertension |
125947732 | 12594773 | 6 | Plasma cell myeloma |
125947732 | 12594773 | 7 | Plasma cell myeloma |
125947732 | 12594773 | 8 | Essential hypertension |
125947732 | 12594773 | 9 | Essential hypertension |
125947732 | 12594773 | 10 | Cardiac failure |
125947732 | 12594773 | 11 | Essential hypertension |
125947732 | 12594773 | 12 | Atrial fibrillation |
125947732 | 12594773 | 13 | Bone pain |
125947732 | 12594773 | 14 | Prophylaxis |
125947732 | 12594773 | 15 | Mineral supplementation |
125947732 | 12594773 | 16 | Gastritis prophylaxis |
125947732 | 12594773 | 17 | Gastritis prophylaxis |
125947732 | 12594773 | 18 | Erythropoiesis abnormal |
125947732 | 12594773 | 19 | Hyperuricaemia |
125947732 | 12594773 | 21 | Pneumonia |
125947732 | 12594773 | 22 | Essential hypertension |
125947732 | 12594773 | 23 | Essential hypertension |
125947732 | 12594773 | 24 | Neutropenia |
125947732 | 12594773 | 25 | Hypoalbuminaemia |
125947732 | 12594773 | 26 | Pneumonia |
125947732 | 12594773 | 27 | Thrombosis prophylaxis |
125947732 | 12594773 | 30 | Prophylaxis |
125947732 | 12594773 | 31 | Prophylaxis |
125947732 | 12594773 | 32 | Pneumonia |
125947732 | 12594773 | 33 | Pneumonia |
125947732 | 12594773 | 34 | Antifungal prophylaxis |
125947732 | 12594773 | 35 | Pneumonia |
125947732 | 12594773 | 36 | Tracheobronchitis |
125947732 | 12594773 | 37 | Pneumonia |
125947732 | 12594773 | 38 | Pneumonia |
125947732 | 12594773 | 39 | Tracheobronchitis |
125947732 | 12594773 | 40 | Tracheobronchitis |
125947732 | 12594773 | 41 | Laceration |
125947732 | 12594773 | 42 | Laceration |
125947732 | 12594773 | 43 | Laceration |
125947732 | 12594773 | 44 | Laceration |
125947732 | 12594773 | 45 | Orthostatic hypotension |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125947732 | 12594773 | HO |
125947732 | 12594773 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125947732 | 12594773 | Anaemia | |
125947732 | 12594773 | Bone pain | |
125947732 | 12594773 | Diarrhoea | |
125947732 | 12594773 | Hyperuricaemia | |
125947732 | 12594773 | Hypoalbuminaemia | |
125947732 | 12594773 | Laceration | |
125947732 | 12594773 | Neutropenia | |
125947732 | 12594773 | Orthostatic hypotension | |
125947732 | 12594773 | Pleural effusion | |
125947732 | 12594773 | Pneumonia | |
125947732 | 12594773 | Pyrexia | |
125947732 | 12594773 | Thrombocytopenia | |
125947732 | 12594773 | Tracheobronchitis |
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 |
---|---|---|---|---|---|---|
125947732 | 12594773 | 1 | 20160415 | 0 | ||
125947732 | 12594773 | 3 | 20160416 | 0 | ||
125947732 | 12594773 | 4 | 20160415 | 0 | ||
125947732 | 12594773 | 5 | 20140513 | 20160428 | 0 | |
125947732 | 12594773 | 6 | 20160415 | 0 | ||
125947732 | 12594773 | 7 | 20160415 | 0 | ||
125947732 | 12594773 | 8 | 20140513 | 20160428 | 0 | |
125947732 | 12594773 | 9 | 20140513 | 20160428 | 0 | |
125947732 | 12594773 | 10 | 20140513 | 20160428 | 0 | |
125947732 | 12594773 | 11 | 20160525 | 0 | ||
125947732 | 12594773 | 12 | 20140513 | 20160429 | 0 | |
125947732 | 12594773 | 13 | 20160321 | 0 | ||
125947732 | 12594773 | 14 | 20160415 | 0 | ||
125947732 | 12594773 | 15 | 20160418 | 20160418 | 0 | |
125947732 | 12594773 | 16 | 20160415 | 20160415 | 0 | |
125947732 | 12594773 | 17 | 20160416 | 20160418 | 0 | |
125947732 | 12594773 | 18 | 20160530 | 0 | ||
125947732 | 12594773 | 19 | 20160429 | 20160502 | 0 | |
125947732 | 12594773 | 20 | 20160603 | 20160612 | 0 | |
125947732 | 12594773 | 21 | 20160525 | 20160603 | 0 | |
125947732 | 12594773 | 22 | 20160525 | 0 | ||
125947732 | 12594773 | 24 | 20160509 | 20160515 | 0 | |
125947732 | 12594773 | 25 | 20160509 | 20160515 | 0 | |
125947732 | 12594773 | 26 | 20160509 | 20160517 | 0 | |
125947732 | 12594773 | 27 | 20160511 | 20160515 | 0 | |
125947732 | 12594773 | 28 | 20160516 | 20160517 | 0 | |
125947732 | 12594773 | 29 | 20160518 | 20160524 | 0 | |
125947732 | 12594773 | 30 | 20160511 | 20160511 | 0 | |
125947732 | 12594773 | 31 | 20160511 | 20160511 | 0 | |
125947732 | 12594773 | 32 | 20160509 | 20160524 | 0 | |
125947732 | 12594773 | 33 | 20160512 | 20160524 | 0 | |
125947732 | 12594773 | 34 | 20160512 | 20160524 | 0 | |
125947732 | 12594773 | 35 | 20160509 | 20160515 | 0 | |
125947732 | 12594773 | 36 | 20160503 | 20160508 | 0 | |
125947732 | 12594773 | 37 | 20160509 | 20160517 | 0 | |
125947732 | 12594773 | 38 | 20160507 | 20160522 | 0 | |
125947732 | 12594773 | 39 | 20160429 | 20160508 | 0 | |
125947732 | 12594773 | 40 | 20160429 | 20160502 | 0 | |
125947732 | 12594773 | 41 | 20160429 | 20160512 | 0 | |
125947732 | 12594773 | 42 | 20160429 | 20160502 | 0 | |
125947732 | 12594773 | 43 | 20160429 | 20160502 | 0 | |
125947732 | 12594773 | 44 | 20160429 | 20160502 | 0 | |
125947732 | 12594773 | 45 | 20160429 | 20160508 | 0 |