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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125879731 | 12587973 | 1 | I | 20150713 | 20150908 | 20160725 | 20160725 | EXP | GB-CONCORDIA PHARMACEUTICALS INC.-GSH201509-014214 | CONCORDIA | 79.00 | YR | F | Y | 68.00000 | KG | 20160725 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125879731 | 12587973 | 1 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 500 | MG | U | UNKNOWN | 21959 | 100 | MG | QD | ||||
| 125879731 | 12587973 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 500 | MG | U | UNKNOWN | 21959 | 5 | MG | QD | ||||
| 125879731 | 12587973 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 500 | MG | U | UNKNOWN | 21959 | 10 | MG | |||||
| 125879731 | 12587973 | 4 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | 87575 | MG | 0 | 200 | MG | TID | ||||||
| 125879731 | 12587973 | 5 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | ONCE ON DAY 1 OF EVERY 21 DAY CYCLE | 0 | 1300 | MG | /cycle | |||||||
| 125879731 | 12587973 | 6 | C | FERROUS FUMARATE | FERROUS FUMARATE | 1 | Oral | 0 | 210 | MG | BID | ||||||||
| 125879731 | 12587973 | 7 | C | GLICLAZIDE | GLICLAZIDE | 1 | Unknown | 87120 | MG | 0 | 30 | MG | QD | ||||||
| 125879731 | 12587973 | 8 | C | GRANULOCYTE-COLONY STIMULATING FACTOR | FILGRASTIM | 1 | Subcutaneous | 0 | QD | ||||||||||
| 125879731 | 12587973 | 9 | C | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | FORM: POWDER FOR SOLUTION FOR INJECTION. | UNKNOWN | 0 | 1.4 | MG | /cycle | ||||||
| 125879731 | 12587973 | 10 | C | INSULIN | INSULIN NOS | 1 | Subcutaneous | DOSE:18 UNIT(S) | 0 | QD | |||||||||
| 125879731 | 12587973 | 11 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 78000 | MG | 0 | 30 | MG | QD | ||||||
| 125879731 | 12587973 | 12 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 61419.1666 | MG | 0 | 20 | MG | QD | ||||||
| 125879731 | 12587973 | 13 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 663000 | MG | 0 | 500 | MG | BID | ||||||
| 125879731 | 12587973 | 14 | C | RITUXIMAB | RITUXIMAB | 1 | Intravenous (not otherwise specified) | ONCE ON DAY 1 OF EVERY 21 DAY CYCLE | 0 | 700 | MG | /cycle | |||||||
| 125879731 | 12587973 | 15 | C | THYROXINE | LEVOTHYROXINE | 1 | Unknown | 0 | QD | ||||||||||
| 125879731 | 12587973 | 16 | C | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | Unknown | 480 MG ONCE DAILY THREE TIMES WEEKLY | 3336.19047 | MG | 0 | 480 | MG | Q3W | |||||
| 125879731 | 12587973 | 17 | C | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | ONCE ON DAY 1 OF EVERY 21 DAY CYCLE | 0 | 1 | MG | /cycle |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125879731 | 12587973 | 1 | Diffuse large B-cell lymphoma |
| 125879731 | 12587973 | 2 | Diffuse large B-cell lymphoma |
| 125879731 | 12587973 | 3 | Diffuse large B-cell lymphoma |
| 125879731 | 12587973 | 4 | Antiviral prophylaxis |
| 125879731 | 12587973 | 5 | Diffuse large B-cell lymphoma |
| 125879731 | 12587973 | 6 | Anaemia |
| 125879731 | 12587973 | 7 | Diabetes mellitus |
| 125879731 | 12587973 | 8 | Prophylaxis |
| 125879731 | 12587973 | 9 | Diffuse large B-cell lymphoma |
| 125879731 | 12587973 | 10 | Diabetes mellitus |
| 125879731 | 12587973 | 11 | Prophylaxis |
| 125879731 | 12587973 | 12 | Hypertension |
| 125879731 | 12587973 | 13 | Diabetes mellitus |
| 125879731 | 12587973 | 14 | Diffuse large B-cell lymphoma |
| 125879731 | 12587973 | 15 | Hypothyroidism |
| 125879731 | 12587973 | 16 | Antibiotic prophylaxis |
| 125879731 | 12587973 | 17 | Diffuse large B-cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125879731 | 12587973 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125879731 | 12587973 | Confusional state | |
| 125879731 | 12587973 | Fatigue | |
| 125879731 | 12587973 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 125879731 | 12587973 | 1 | 20150708 | 20150712 | 0 | |
| 125879731 | 12587973 | 2 | 20150714 | 20150714 | 0 | |
| 125879731 | 12587973 | 3 | 20150713 | 20150713 | 0 | |
| 125879731 | 12587973 | 4 | 20150217 | 20150716 | 0 | |
| 125879731 | 12587973 | 5 | 20150217 | 20150708 | 0 | |
| 125879731 | 12587973 | 6 | 20150716 | 0 | ||
| 125879731 | 12587973 | 7 | 20070731 | 20150716 | 0 | |
| 125879731 | 12587973 | 8 | 20150220 | 20150715 | 0 | |
| 125879731 | 12587973 | 9 | 20150218 | 20150428 | 0 | |
| 125879731 | 12587973 | 10 | 20110211 | 20150716 | 0 | |
| 125879731 | 12587973 | 11 | 20080530 | 20150716 | 0 | |
| 125879731 | 12587973 | 12 | 20070214 | 20150716 | 0 | |
| 125879731 | 12587973 | 13 | 20130918 | 20150715 | 0 | |
| 125879731 | 12587973 | 14 | 20150217 | 20150708 | 0 | |
| 125879731 | 12587973 | 15 | 20070214 | 20150716 | 0 | |
| 125879731 | 12587973 | 16 | 20150217 | 20150715 | 0 | |
| 125879731 | 12587973 | 17 | 20150217 | 20150708 | 0 |