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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124980682 | 12498068 | 2 | F | 20160413 | 20160624 | 20160626 | 20160703 | EXP | US-BAXTER-2016BAX028453 | BAXTER | 12.00 | YR | M | Y | 50.00000 | KG | 20160703 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124980682 | 12498068 | 1 | PS | MESNA FOR INJECTION 1 GRAM | MESNA | 1 | Unknown | CYCLE 1 | U | 19884 | SOLUTION FOR INJECTION | /cycle | |||||||
| 124980682 | 12498068 | 2 | SS | MESNA FOR INJECTION 1 GRAM | MESNA | 1 | Unknown | CYCLE 3 | U | 19884 | SOLUTION FOR INJECTION | /cycle | |||||||
| 124980682 | 12498068 | 3 | SS | MESNA FOR INJECTION 1 GRAM | MESNA | 1 | Unknown | CYCLE 5 | U | 19884 | SOLUTION FOR INJECTION | /cycle | |||||||
| 124980682 | 12498068 | 4 | SS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | PROPHASE: OVER 15-30 MINUTES ON DAYS 1 AND 2 | U | 40745 | 200 | MG/M**2 | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 124980682 | 12498068 | 5 | SS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | COURSE B (21 DAYS), CYCLES 2, 4, OVER 15-30 MINUTES ON DAYS 1-5 | U | 40745 | 200 | MG/M**2 | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 124980682 | 12498068 | 6 | SS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | COURSE B (21 DAYS), CYCLES 2, 4, OVER 15-30 MINUTES ON DAYS 1-5 | U | 40745 | 200 | MG/M**2 | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 124980682 | 12498068 | 7 | SS | IFOSFAMIDE FOR INJECTION | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | OVER 60 MINS ON DAYS 1-5, COURSE A, CYCLES 1, 3, 5 (CYCLE OF 21 DAYS) | U | 19763 | 800 | MG/M**2 | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 124980682 | 12498068 | 8 | SS | IFOSFAMIDE FOR INJECTION | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | LAST ADMINISTERED DATE (CYCLE 5) | U | 19763 | 800 | MG/M**2 | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 124980682 | 12498068 | 9 | SS | crizotinib | CRIZOTINIB | 1 | Oral | COURSE A (21 DAYS), CYCLES 1, 3, 5, TWICE DAILY ON DAYS 1-21 | U | 0 | 165 | MG/M**2 | BID | ||||||
| 124980682 | 12498068 | 10 | SS | crizotinib | CRIZOTINIB | 1 | Oral | COURSE B (21 DAYS), CYCLES 2, 4, TWICE DAILY ON DAYS 1-21 | U | 0 | 165 | MG/M**2 | BID | ||||||
| 124980682 | 12498068 | 11 | SS | crizotinib | CRIZOTINIB | 1 | Oral | COURSE B (21 DAYS), CYCLE 6, TWICE DAILY ON DAYS 1-21 | U | 0 | 165 | MG/M**2 | BID | ||||||
| 124980682 | 12498068 | 12 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | COURSE B (21 DAYS), CYCLES 2, 4, OVER 1-15 MIN ON DAYS 4 AND 5 | U | 0 | 25 | MG/M**2 | |||||||
| 124980682 | 12498068 | 13 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | COURSE B (21 DAYS), CYCLE 6, OVER 1-15 MIN ON DAYS 4 AND 5 | U | 0 | 25 | MG/M**2 | |||||||
| 124980682 | 12498068 | 14 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intrathecal | PROPHASE: 7.5 MG - 12 MG ON DAY 1 (AGE BASED DOSING) | U | 0 | |||||||||
| 124980682 | 12498068 | 15 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intravenous (not otherwise specified) | COURSE A (21 DAYS), CYCLES 1, 3, 5, ON DAY 1 | U | 0 | 3000 | MG/M**2 | |||||||
| 124980682 | 12498068 | 16 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intravenous (not otherwise specified) | COURSE B (21 DAYS), CYCLES 2, 4, ON DAY 1 | U | 0 | 3000 | MG/M**2 | |||||||
| 124980682 | 12498068 | 17 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intravenous (not otherwise specified) | COURSE B (21 DAYS), CYCLE 6, ON DAY 1 | U | 0 | 3000 | MG/M**2 | |||||||
| 124980682 | 12498068 | 18 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | PROPHASE: ONCE DAILY ON DAYS 1 AND 2 | U | 0 | 5 | MG/M**2 | QD | ||||||
| 124980682 | 12498068 | 19 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | PROPHASE: BID ON DAYS 3-5 | U | 0 | 5 | MG/M**2 | BID | ||||||
| 124980682 | 12498068 | 20 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | COURSE A (21 DAYS CYCLES), CYCLE 1, 3, 5, TWICE DAILY ON DAYS 1-5 | U | 0 | 5 | MG/M**2 | BID | ||||||
| 124980682 | 12498068 | 21 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | COURSE B (21 DAYS), CYCLES 2, 4, ON DAYS 1-5 | U | 0 | 5 | MG/M**2 | BID | ||||||
| 124980682 | 12498068 | 22 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | COURSE B (21 DAYS), CYCLES 6 ON DAYS 1-5 | U | 0 | 5 | MG/M**2 | BID | ||||||
| 124980682 | 12498068 | 23 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intrathecal | PROPHASE: 7.5 MG-12 MG ON DAY 1 (AGE BASED DOSING) | U | 0 | |||||||||
| 124980682 | 12498068 | 24 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | PROPHASE: 15-24 MG ON DAY 1 (AGE BASED DOSING) | U | 0 | |||||||||
| 124980682 | 12498068 | 25 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | COURSE A (21 DAYS), CYCLES 1, 3, 5, OVER 1-30 MINUTES EVERY 12 HOURS, ON DAYS 4 AND 5 (TOTAL 4 DOSES | U | 0 | 150 | MG/M**2 | Q12H | ||||||
| 124980682 | 12498068 | 26 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | LAST ADMINISTERED DATE (CYCLE 5) | U | 0 | 150 | MG/M**2 | Q12H | ||||||
| 124980682 | 12498068 | 27 | SS | etoposide VP-16 | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | COURSE A (21 DAYS), CYCLES 1, 3, 5, OVER 2 HOURS ON DAYS 4 AND 5 | U | 0 | 100 | MG/M**2 | |||||||
| 124980682 | 12498068 | 28 | SS | etoposide VP-16 | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | LAST ADMINISTERED DATE (CYCLE 5) | U | 0 | 100 | MG/M**2 | |||||||
| 124980682 | 12498068 | 29 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | CYCLE 1 | U | 0 | /cycle | ||||||||
| 124980682 | 12498068 | 30 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | CYCLE 2 | U | 0 | /cycle | ||||||||
| 124980682 | 12498068 | 31 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | CYCLE 3 | U | 0 | /cycle | ||||||||
| 124980682 | 12498068 | 32 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | CYCLE 4 | U | 0 | /cycle | ||||||||
| 124980682 | 12498068 | 33 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | CYCLE 5 | U | 0 | /cycle | ||||||||
| 124980682 | 12498068 | 34 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | CYCLE 6 | U | 0 | /cycle |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124980682 | 12498068 | 1 | Product used for unknown indication |
| 124980682 | 12498068 | 4 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 7 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 9 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 12 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 14 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 18 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 23 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 24 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 27 | Anaplastic large cell lymphoma T- and null-cell types |
| 124980682 | 12498068 | 29 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124980682 | 12498068 | HO |
| 124980682 | 12498068 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124980682 | 12498068 | Anaemia | |
| 124980682 | 12498068 | Bacterial sepsis | |
| 124980682 | 12498068 | Febrile neutropenia | |
| 124980682 | 12498068 | Hypotension | |
| 124980682 | 12498068 | Pulmonary oedema | |
| 124980682 | 12498068 | Respiratory failure | |
| 124980682 | 12498068 | Rhinovirus infection | |
| 124980682 | 12498068 | Septic shock | |
| 124980682 | 12498068 | Stomatitis | |
| 124980682 | 12498068 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 124980682 | 12498068 | 1 | 20151207 | 20151212 | 0 | |
| 124980682 | 12498068 | 2 | 20160122 | 20160126 | 0 | |
| 124980682 | 12498068 | 3 | 20160312 | 20160316 | 0 | |
| 124980682 | 12498068 | 6 | 20160402 | 20160406 | 0 | |
| 124980682 | 12498068 | 7 | 20151130 | 0 | ||
| 124980682 | 12498068 | 8 | 20160316 | 20160316 | 0 | |
| 124980682 | 12498068 | 9 | 20151130 | 0 | ||
| 124980682 | 12498068 | 11 | 20160402 | 20160411 | 0 | |
| 124980682 | 12498068 | 13 | 20160405 | 20160406 | 0 | |
| 124980682 | 12498068 | 17 | 20160402 | 20160402 | 0 | |
| 124980682 | 12498068 | 22 | 20160402 | 20160406 | 0 | |
| 124980682 | 12498068 | 26 | 20160316 | 20160316 | 0 | |
| 124980682 | 12498068 | 28 | 20160316 | 20160316 | 0 | |
| 124980682 | 12498068 | 29 | 20150209 | 20150210 | 0 | |
| 124980682 | 12498068 | 30 | 20151231 | 20160301 | 0 | |
| 124980682 | 12498068 | 31 | 20160123 | 20160124 | 0 | |
| 124980682 | 12498068 | 32 | 20160221 | 20160222 | 0 | |
| 124980682 | 12498068 | 33 | 20160313 | 20160315 | 0 | |
| 124980682 | 12498068 | 34 | 20160403 | 20160409 | 0 |