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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
122899074 | 12289907 | 4 | F | 20150526 | 20160805 | 20160421 | 20160811 | EXP | US-ASTELLAS-2015US018334 | ASTELLAS | 53.67 | YR | M | Y | 0.00000 | 20160811 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
122899074 | 12289907 | 1 | SS | BLINDED ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | 0 | INJECTION | ||||||||||
122899074 | 12289907 | 2 | SS | BLINDED ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | 0 | INJECTION | ||||||||||
122899074 | 12289907 | 3 | SS | BLINDED ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | 0 | INJECTION | ||||||||||
122899074 | 12289907 | 4 | SS | BLINDED ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | 0 | INJECTION | ||||||||||
122899074 | 12289907 | 5 | SS | BLINDED ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | 0 | INJECTION | ||||||||||
122899074 | 12289907 | 6 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 2.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 10 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 8 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 5.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 10 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 4.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 11 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 12 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 4.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 13 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 14 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 7 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 15 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 7.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 16 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 8 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 17 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 7 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 18 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 7.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 19 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 7 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 20 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 7.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 21 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 5.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 22 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 6 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 23 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 6 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 24 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 7.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 25 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 3.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 26 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 27 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 6.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 28 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 8.5 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 29 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 0 | 2000 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 30 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 0 | 1500 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 31 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 0 | 1000 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 32 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 0 | 500 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 33 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 0 | 1000 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 34 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 0 | 2000 | MG | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 35 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 36 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 37 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
122899074 | 12289907 | 38 | C | MUPIROCIN. | MUPIROCIN | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | OINTMENT | ||||||||
122899074 | 12289907 | 39 | C | ATIVAN | LORAZEPAM | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 40 | C | ATIVAN | LORAZEPAM | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
122899074 | 12289907 | 41 | C | OXYCODONE | OXYCODONE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 42 | C | OXYCODONE | OXYCODONE | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
122899074 | 12289907 | 43 | C | OXYCODONE | OXYCODONE | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
122899074 | 12289907 | 44 | C | ELIQUIS | APIXABAN | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 45 | C | ELIQUIS | APIXABAN | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
122899074 | 12289907 | 46 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 47 | C | TRAMADOL. | TRAMADOL | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 48 | C | TRAMADOL. | TRAMADOL | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
122899074 | 12289907 | 49 | C | MULTIVITAMIN /00097801/ | VITAMINS | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 50 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 51 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
122899074 | 12289907 | 52 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 53 | C | DELSYM | DEXTROMETHORPHAN | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 54 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Sublingual | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 55 | C | DAPSONE. | DAPSONE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 56 | C | PENICILLIN VK | PENICILLIN V POTASSIUM | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 57 | C | NYSTATIN. | NYSTATIN | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 58 | C | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 59 | C | IBRUTINIB | IBRUTINIB | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
122899074 | 12289907 | 60 | C | ACYCLOVIR /00587301/ | ACYCLOVIR | 1 | Oral | U | 0 | 1600 | MG | FORMULATION UNKNOWN | |||||||
122899074 | 12289907 | 61 | C | ACYCLOVIR /00587301/ | ACYCLOVIR | 1 | Oral | U | 0 | 800 | MG | FORMULATION UNKNOWN | |||||||
122899074 | 12289907 | 62 | C | ACYCLOVIR /00587301/ | ACYCLOVIR | 1 | Oral | U | 0 | 1600 | MG | FORMULATION UNKNOWN |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
122899074 | 12289907 | 1 | Immunisation |
122899074 | 12289907 | 6 | Prophylaxis against graft versus host disease |
122899074 | 12289907 | 29 | Prophylaxis against graft versus host disease |
122899074 | 12289907 | 35 | Vitamin D deficiency |
122899074 | 12289907 | 36 | Dyspepsia |
122899074 | 12289907 | 37 | Gastrooesophageal reflux disease |
122899074 | 12289907 | 38 | Chronic sinusitis |
122899074 | 12289907 | 39 | Nausea |
122899074 | 12289907 | 40 | Vomiting |
122899074 | 12289907 | 41 | Pain |
122899074 | 12289907 | 42 | Arthralgia |
122899074 | 12289907 | 43 | Arthralgia |
122899074 | 12289907 | 44 | Thrombosis |
122899074 | 12289907 | 45 | Hypercoagulation |
122899074 | 12289907 | 46 | Hypomagnesaemia |
122899074 | 12289907 | 47 | Headache |
122899074 | 12289907 | 48 | Pain |
122899074 | 12289907 | 49 | Malnutrition |
122899074 | 12289907 | 50 | Nausea |
122899074 | 12289907 | 51 | Vomiting |
122899074 | 12289907 | 52 | Pneumonia |
122899074 | 12289907 | 53 | Cough |
122899074 | 12289907 | 54 | Oral pain |
122899074 | 12289907 | 55 | Pneumocystis jirovecii pneumonia |
122899074 | 12289907 | 56 | Bacterial infection |
122899074 | 12289907 | 57 | Oral pain |
122899074 | 12289907 | 58 | Acute graft versus host disease in skin |
122899074 | 12289907 | 59 | Chronic lymphocytic leukaemia |
122899074 | 12289907 | 60 | Prophylaxis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
122899074 | 12289907 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
122899074 | 12289907 | Bronchopulmonary aspergillosis | |
122899074 | 12289907 | Hypoxia | |
122899074 | 12289907 | Lower respiratory tract infection bacterial |
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 |
---|---|---|---|---|---|---|
122899074 | 12289907 | 1 | 20141121 | 20141121 | 0 | |
122899074 | 12289907 | 2 | 20141219 | 20141219 | 0 | |
122899074 | 12289907 | 3 | 20150123 | 20150123 | 0 | |
122899074 | 12289907 | 4 | 20150225 | 20150225 | 0 | |
122899074 | 12289907 | 5 | 20150526 | 20150526 | 0 | |
122899074 | 12289907 | 6 | 20150505 | 20150606 | 0 | |
122899074 | 12289907 | 7 | 20141122 | 20141128 | 0 | |
122899074 | 12289907 | 8 | 20141128 | 20141205 | 0 | |
122899074 | 12289907 | 9 | 20141205 | 20141208 | 0 | |
122899074 | 12289907 | 10 | 20141209 | 20141222 | 0 | |
122899074 | 12289907 | 11 | 20141223 | 20150108 | 0 | |
122899074 | 12289907 | 12 | 20150109 | 20150116 | 0 | |
122899074 | 12289907 | 13 | 20150117 | 20150206 | 0 | |
122899074 | 12289907 | 14 | 20150207 | 20150223 | 0 | |
122899074 | 12289907 | 15 | 20150224 | 20150302 | 0 | |
122899074 | 12289907 | 16 | 20150303 | 20150309 | 0 | |
122899074 | 12289907 | 17 | 20150310 | 20150323 | 0 | |
122899074 | 12289907 | 18 | 20150324 | 20150326 | 0 | |
122899074 | 12289907 | 19 | 20150327 | 20150331 | 0 | |
122899074 | 12289907 | 20 | 20150401 | 20150405 | 0 | |
122899074 | 12289907 | 21 | 20150406 | 20150420 | 0 | |
122899074 | 12289907 | 22 | 20150421 | 20150424 | 0 | |
122899074 | 12289907 | 23 | 20150425 | 20150427 | 0 | |
122899074 | 12289907 | 24 | 20150428 | 20150504 | 0 | |
122899074 | 12289907 | 25 | 20150606 | 20150616 | 0 | |
122899074 | 12289907 | 26 | 20150616 | 20150619 | 0 | |
122899074 | 12289907 | 27 | 20150619 | 20150623 | 0 | |
122899074 | 12289907 | 28 | 20150623 | 0 | ||
122899074 | 12289907 | 29 | 20150504 | 20150604 | 0 | |
122899074 | 12289907 | 30 | 20141125 | 20141226 | 0 | |
122899074 | 12289907 | 31 | 20150604 | 20150623 | 0 | |
122899074 | 12289907 | 32 | 20150623 | 20150630 | 0 | |
122899074 | 12289907 | 33 | 20150630 | 20150705 | 0 | |
122899074 | 12289907 | 34 | 20150705 | 0 | ||
122899074 | 12289907 | 35 | 20141113 | 0 | ||
122899074 | 12289907 | 36 | 20141128 | 0 | ||
122899074 | 12289907 | 38 | 20141001 | 0 | ||
122899074 | 12289907 | 39 | 20141121 | 0 | ||
122899074 | 12289907 | 41 | 20141121 | 0 | ||
122899074 | 12289907 | 44 | 20150122 | 0 | ||
122899074 | 12289907 | 46 | 20150123 | 0 | ||
122899074 | 12289907 | 47 | 20141205 | 0 | ||
122899074 | 12289907 | 49 | 20141205 | 0 | ||
122899074 | 12289907 | 50 | 20141121 | 0 | ||
122899074 | 12289907 | 52 | 20150324 | 0 | ||
122899074 | 12289907 | 53 | 20150327 | 0 | ||
122899074 | 12289907 | 54 | 20150504 | 0 | ||
122899074 | 12289907 | 55 | 20150330 | 0 | ||
122899074 | 12289907 | 56 | 20150420 | 0 | ||
122899074 | 12289907 | 57 | 20150518 | 0 | ||
122899074 | 12289907 | 58 | 20150414 | 0 | ||
122899074 | 12289907 | 59 | 20150406 | 20150526 | 0 | |
122899074 | 12289907 | 60 | 20141121 | 20141212 | 0 | |
122899074 | 12289907 | 61 | 20141212 | 20150302 | 0 | |
122899074 | 12289907 | 62 | 20150302 | 0 |