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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124613952 | 12461395 | 2 | F | 20151123 | 20160824 | 20160613 | 20160906 | EXP | US-ASTELLAS-2016US009877 | ASTELLAS | 21.34 | YR | F | Y | 56.00000 | KG | 20160906 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124613952 | 12461395 | 1 | PS | AMBISOME | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | 9280 | MG | U | 50740 | 290 | MG | INJECTION | QD | ||||
| 124613952 | 12461395 | 2 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 1.28 MG, CYCLIC (CYCLE 1 DAY 1) | 12-004948 | 0 | 1.28 | MG | INFUSION | ||||||
| 124613952 | 12461395 | 3 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0.8 MG, CYCLIC (CYCLE 1 DAY 8) | 12-004948 | 0 | .8 | MG | INFUSION | ||||||
| 124613952 | 12461395 | 4 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0.8 MG, CYCLIC (CYCLE 1 DAY 15) | 12-004948 | 0 | .8 | MG | INFUSION | ||||||
| 124613952 | 12461395 | 5 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 1.26 MG, CYCLIC (CYCLE 2 DAY 1) | 12-004948 | 0 | 1.26 | MG | INFUSION | ||||||
| 124613952 | 12461395 | 6 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0.8 MG, CYCLIC (CYCLE 2 DAY 8) | 12-004948 | 0 | .8 | MG | INFUSION | ||||||
| 124613952 | 12461395 | 7 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0.8 MG, CYCLIC (CYCLE 2 DAY 15) | 12-004948 | 0 | .8 | MG | INFUSION | ||||||
| 124613952 | 12461395 | 8 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 124613952 | 12461395 | 9 | SS | POSACONAZOLE | POSACONAZOLE | 1 | Oral | 2800 | MG | U | 0 | 400 | MG | TABLET | QD | ||||
| 124613952 | 12461395 | 10 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Oral | 25 MG, OTHER (ONCE) | U | 0 | 25 | MG | CAPSULE | ||||||
| 124613952 | 12461395 | 11 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Oral | 50 MG, EVERY 8 HOURS AS NEEDED | U | 0 | 50 | MG | CAPSULE | Q8H | |||||
| 124613952 | 12461395 | 12 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 25 MG, OTHER (ONCE) | U | 0 | 25 | MG | CAPSULE | ||||||
| 124613952 | 12461395 | 13 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG | CAPSULE | QD | ||||||
| 124613952 | 12461395 | 14 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 650 MG, OTHER (ONCE) | 1300 | MG | U | 0 | 650 | MG | TABLET | ||||
| 124613952 | 12461395 | 15 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 325-850 MG (ONCE) | 1300 | MG | U | 0 | TABLET | ||||||
| 124613952 | 12461395 | 16 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 650 MG, ONCE DAILY AS NEEDED | 1300 | MG | U | 0 | 650 | MG | TABLET | QD | |||
| 124613952 | 12461395 | 17 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 650 MG, ONCE DAILY AS NEEDED | 1300 | MG | U | 0 | 650 | MG | TABLET | QD | |||
| 124613952 | 12461395 | 18 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 650 MG, EVERY 8 HOURS AS NEEDED | 1300 | MG | U | 0 | 650 | MG | TABLET | Q8H | |||
| 124613952 | 12461395 | 19 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 8 MG, OTHER (ONCE) | U | 0 | 8 | MG | TABLET | ||||||
| 124613952 | 12461395 | 20 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 ML, OTHER (ONCE) | U | 0 | 1000 | ML | FORMULATION UNKNOWN | ||||||
| 124613952 | 12461395 | 21 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | U | 0 | 125 | MG | TABLET | QD | ||||||
| 124613952 | 12461395 | 22 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | U | 0 | 40 | MG | TABLET | QD | ||||||
| 124613952 | 12461395 | 23 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | TABLET | ||||||||||
| 124613952 | 12461395 | 24 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | U | 0 | 75 | UG | TABLET | QD | ||||||
| 124613952 | 12461395 | 25 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | U | 0 | 200 | MG | TABLET | BID | ||||||
| 124613952 | 12461395 | 26 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 800 MG, TWICE DAILY (ON MONDAY, WEDNESSDAY AND FRIDAY) | U | 0 | 800 | MG | TABLET | BID | |||||
| 124613952 | 12461395 | 27 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | U | 0 | 400 | MG | TABLET | QD | ||||||
| 124613952 | 12461395 | 28 | C | ACYCLOVIR /00587301/ | ACYCLOVIR | 1 | Oral | U | 0 | 800 | MG | TABLET | BID | ||||||
| 124613952 | 12461395 | 29 | C | LEVOFLOXACINE | LEVOFLOXACIN | 1 | Oral | U | 0 | 500 | MG | FORMULATION UNKNOWN | QD | ||||||
| 124613952 | 12461395 | 30 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Oral | 15 MG, ONCE DAILY IN AM | U | 0 | 15 | MG | TABLET | QD | |||||
| 124613952 | 12461395 | 31 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Oral | 10 MG, ONCE DAILY IN AM | U | 0 | 10 | MG | TABLET | QD | |||||
| 124613952 | 12461395 | 32 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 0.5 MG, DAILY AT BEDTIME | U | 0 | .5 | MG | TABLET | QD | |||||
| 124613952 | 12461395 | 33 | C | AMPHOTERICIN B DEOXYCHOLATE | AMPHOTERICIN B | 1 | Nasal | U | 0 | 200 | UG | FORMULATION UNKNOWN | BID | ||||||
| 124613952 | 12461395 | 34 | C | CASPOFUNGIN | CASPOFUNGIN | 1 | Intravenous (not otherwise specified) | 70 | MG | U | 0 | 70 | MG | FORMULATION UNKNOWN | QD | ||||
| 124613952 | 12461395 | 35 | C | CASPOFUNGIN | CASPOFUNGIN | 1 | Intravenous (not otherwise specified) | 70 | MG | U | 0 | 50 | MG | FORMULATION UNKNOWN | QD | ||||
| 124613952 | 12461395 | 36 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 0 | 2000 | MG | FORMULATION UNKNOWN | Q8H | ||||||
| 124613952 | 12461395 | 37 | C | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 198 | G | U | 0 | 4.5 | G | FORMULATION UNKNOWN | Q6H | ||||
| 124613952 | 12461395 | 38 | C | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 14400 | MG | U | 0 | 1000 | MG | FORMULATION UNKNOWN | Q8H | ||||
| 124613952 | 12461395 | 39 | C | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 14400 | MG | U | 0 | 800 | MG | FORMULATION UNKNOWN | Q8H | ||||
| 124613952 | 12461395 | 40 | C | ALTEPLASE | ALTEPLASE | 1 | Intravenous (not otherwise specified) | U | 0 | 2 | MG | FORMULATION UNKNOWN | |||||||
| 124613952 | 12461395 | 41 | C | LORAZEPAM. | LORAZEPAM | 1 | Intravenous (not otherwise specified) | 1 MG, AS NEEDED EVERY 3 HOURS | U | 0 | 1 | MG | FORMULATION UNKNOWN | ||||||
| 124613952 | 12461395 | 42 | C | PSEUDOEPHEDRINE | PSEUDOEPHEDRINE | 1 | Oral | 60 MG, EVERY 6 HOURS AS NEEDED | U | 0 | 60 | MG | TABLET | Q6H | |||||
| 124613952 | 12461395 | 43 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 150 MG, AS NEEDED AT BED TIME | U | 0 | 150 | MG | TABLET | ||||||
| 124613952 | 12461395 | 44 | C | RANITIDINE. | RANITIDINE | 1 | U | 0 | TABLET | ||||||||||
| 124613952 | 12461395 | 45 | C | PENTAMIDINE | PENTAMIDINE | 1 | Respiratory (inhalation) | 300 MG, ONCE | U | 0 | 300 | MG | FORMULATION UNKNOWN | ||||||
| 124613952 | 12461395 | 46 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 1 G, ONCE | U | 0 | 1 | G | FORMULATION UNKNOWN | ||||||
| 124613952 | 12461395 | 47 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 2 G, ONCE | U | 0 | 2 | G | FORMULATION UNKNOWN | ||||||
| 124613952 | 12461395 | 48 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 2 G, ONCE | U | 0 | 2 | G | FORMULATION UNKNOWN | ||||||
| 124613952 | 12461395 | 49 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 2 G, ONCE | U | 0 | 2 | G | FORMULATION UNKNOWN | ||||||
| 124613952 | 12461395 | 50 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 2 G, ONCE | U | 0 | 2 | G | FORMULATION UNKNOWN | ||||||
| 124613952 | 12461395 | 51 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 20 MEQ, ONCE | 20 | MEQ | U | 0 | 20 | MEQ | FORMULATION UNKNOWN | ||||
| 124613952 | 12461395 | 52 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 10 MEQ, ONCE | 20 | MEQ | U | 0 | 10 | MEQ | FORMULATION UNKNOWN | ||||
| 124613952 | 12461395 | 53 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 20 | MEQ | U | 0 | 10 | MEQ | FORMULATION UNKNOWN | QD | ||||
| 124613952 | 12461395 | 54 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 20 MEQ, ONCE | 20 | MEQ | U | 0 | 20 | MEQ | FORMULATION UNKNOWN | ||||
| 124613952 | 12461395 | 55 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Oral | 120 | MEQ | U | 0 | 20 | MEQ | TABLET | QD | ||||
| 124613952 | 12461395 | 56 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Oral | 120 | MEQ | U | 0 | 20 | MEQ | TABLET | QD | ||||
| 124613952 | 12461395 | 57 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Oral | 120 | MEQ | U | 0 | 20 | MEQ | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124613952 | 12461395 | 1 | Fungal infection |
| 124613952 | 12461395 | 2 | Acute lymphocytic leukaemia |
| 124613952 | 12461395 | 8 | Product used for unknown indication |
| 124613952 | 12461395 | 9 | Fungal infection |
| 124613952 | 12461395 | 10 | Premedication |
| 124613952 | 12461395 | 14 | Premedication |
| 124613952 | 12461395 | 15 | Abdominal pain upper |
| 124613952 | 12461395 | 16 | Pyrexia |
| 124613952 | 12461395 | 19 | Nausea |
| 124613952 | 12461395 | 20 | Dehydration |
| 124613952 | 12461395 | 21 | Depression |
| 124613952 | 12461395 | 22 | Prophylaxis |
| 124613952 | 12461395 | 23 | Prophylaxis |
| 124613952 | 12461395 | 24 | Hypothyroidism |
| 124613952 | 12461395 | 25 | Prophylaxis |
| 124613952 | 12461395 | 26 | Prophylaxis |
| 124613952 | 12461395 | 27 | Prophylaxis |
| 124613952 | 12461395 | 28 | Prophylaxis |
| 124613952 | 12461395 | 29 | Prophylaxis |
| 124613952 | 12461395 | 30 | Adrenal insufficiency |
| 124613952 | 12461395 | 32 | Insomnia |
| 124613952 | 12461395 | 33 | Sinusitis fungal |
| 124613952 | 12461395 | 34 | Fungal infection |
| 124613952 | 12461395 | 36 | Febrile neutropenia |
| 124613952 | 12461395 | 37 | Febrile neutropenia |
| 124613952 | 12461395 | 38 | Febrile neutropenia |
| 124613952 | 12461395 | 40 | Device occlusion |
| 124613952 | 12461395 | 41 | Nausea |
| 124613952 | 12461395 | 42 | Nasal congestion |
| 124613952 | 12461395 | 43 | Dyspepsia |
| 124613952 | 12461395 | 44 | Dyspepsia |
| 124613952 | 12461395 | 45 | Prophylaxis |
| 124613952 | 12461395 | 46 | Hypomagnesaemia |
| 124613952 | 12461395 | 51 | Hypokalaemia |
| 124613952 | 12461395 | 55 | Hypokalaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124613952 | 12461395 | OT |
| 124613952 | 12461395 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124613952 | 12461395 | Abdominal operation | |
| 124613952 | 12461395 | Alanine aminotransferase increased | |
| 124613952 | 12461395 | Anaemia | |
| 124613952 | 12461395 | Aspartate aminotransferase increased | |
| 124613952 | 12461395 | Blood alkaline phosphatase increased | |
| 124613952 | 12461395 | Diabetes insipidus | |
| 124613952 | 12461395 | Hyperglycaemia | |
| 124613952 | 12461395 | Hyperkalaemia | |
| 124613952 | 12461395 | Hypernatraemia | |
| 124613952 | 12461395 | Hypocalcaemia | |
| 124613952 | 12461395 | Hypokalaemia | |
| 124613952 | 12461395 | Hypomagnesaemia | |
| 124613952 | 12461395 | Hyponatraemia | |
| 124613952 | 12461395 | Hypophosphataemia | |
| 124613952 | 12461395 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 124613952 | 12461395 | 1 | 20160108 | 20160215 | 0 | |
| 124613952 | 12461395 | 2 | 20151118 | 20151118 | 0 | |
| 124613952 | 12461395 | 3 | 20151125 | 20151125 | 0 | |
| 124613952 | 12461395 | 4 | 20151204 | 20151204 | 0 | |
| 124613952 | 12461395 | 5 | 20160122 | 20160122 | 0 | |
| 124613952 | 12461395 | 6 | 20160201 | 20160201 | 0 | |
| 124613952 | 12461395 | 7 | 20160215 | 20160215 | 0 | |
| 124613952 | 12461395 | 9 | 20160108 | 20160114 | 0 | |
| 124613952 | 12461395 | 10 | 20151123 | 20151123 | 0 | |
| 124613952 | 12461395 | 11 | 20160106 | 0 | ||
| 124613952 | 12461395 | 12 | 20160116 | 20160116 | 0 | |
| 124613952 | 12461395 | 13 | 20160109 | 0 | ||
| 124613952 | 12461395 | 14 | 20151123 | 20151123 | 0 | |
| 124613952 | 12461395 | 15 | 20151123 | 20151123 | 0 | |
| 124613952 | 12461395 | 16 | 20160108 | 20160109 | 0 | |
| 124613952 | 12461395 | 17 | 20160109 | 0 | ||
| 124613952 | 12461395 | 18 | 20160106 | 0 | ||
| 124613952 | 12461395 | 19 | 20151123 | 20151123 | 0 | |
| 124613952 | 12461395 | 20 | 20151123 | 20151123 | 0 | |
| 124613952 | 12461395 | 34 | 20160120 | 20160120 | 0 | |
| 124613952 | 12461395 | 35 | 20160121 | 0 | ||
| 124613952 | 12461395 | 36 | 20160118 | 0 | ||
| 124613952 | 12461395 | 37 | 20160108 | 20160118 | 0 | |
| 124613952 | 12461395 | 38 | 20160108 | 20160111 | 0 | |
| 124613952 | 12461395 | 39 | 20160112 | 20160112 | 0 | |
| 124613952 | 12461395 | 40 | 20160108 | 20160122 | 0 | |
| 124613952 | 12461395 | 41 | 20160110 | 0 | ||
| 124613952 | 12461395 | 42 | 20160121 | 0 | ||
| 124613952 | 12461395 | 43 | 20160121 | 0 | ||
| 124613952 | 12461395 | 45 | 20160111 | 20160111 | 0 | |
| 124613952 | 12461395 | 46 | 20160110 | 20160110 | 0 | |
| 124613952 | 12461395 | 47 | 20160114 | 20160114 | 0 | |
| 124613952 | 12461395 | 48 | 20160116 | 20160116 | 0 | |
| 124613952 | 12461395 | 49 | 20160120 | 20160120 | 0 | |
| 124613952 | 12461395 | 50 | 20160122 | 20160122 | 0 | |
| 124613952 | 12461395 | 51 | 20160109 | 0 | ||
| 124613952 | 12461395 | 52 | 20160113 | 20160113 | 0 | |
| 124613952 | 12461395 | 53 | 20160115 | 20160116 | 0 | |
| 124613952 | 12461395 | 54 | 20160118 | 0 | ||
| 124613952 | 12461395 | 55 | 20160108 | 20160112 | 0 | |
| 124613952 | 12461395 | 56 | 20160112 | 20160112 | 0 | |
| 124613952 | 12461395 | 57 | 20160113 | 0 |