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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117763526 | 11776352 | 6 | F | 20150912 | 20160628 | 20151125 | 20160708 | EXP | GB-MHRA-ADR 23223463 | GB-ACCORD-035545 | ACCORD | 50.00 | YR | A | M | Y | 0.00000 | 20160708 | OT | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117763526 | 11776352 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | DAY 1 OF EACH 14 DAY CYCLE | 85.71 | MG/M2 | 40743 | 400 | MG/M**2 | ||||||
| 117763526 | 11776352 | 2 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 38.57 | MG/M2 | 79068 | 180 | MG/M**2 | |||||||
| 117763526 | 11776352 | 3 | SS | VELIPARIB | VELIPARIB | 1 | Oral | DAY 2 THROUGH 5 OF 14 DAY CYCLE | UNK | 0 | BID | ||||||||
| 117763526 | 11776352 | 4 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 1239.79 | MG | 0 | 5 | MG | QD | ||||||
| 117763526 | 11776352 | 5 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Oral | 22500 | MG/M2 | 0 | 500 | MG | TID | ||||||
| 117763526 | 11776352 | 6 | C | CHLORHEXIDINE | CHLORHEXIDINE | 1 | Oral | 40 ML | 200 | ML | 0 | 10 | ML | QID | |||||
| 117763526 | 11776352 | 7 | C | AMOXICILLIN SODIUM/CLAVULANATE POTASSIUM | 2 | Oral | 3750 | MG | 0 | 125 | MG | TID | |||||||
| 117763526 | 11776352 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8 MG | 24 | MG | 0 | 4 | MG | BID | |||||
| 117763526 | 11776352 | 9 | C | DOMPERIDONE | DOMPERIDONE | 1 | Oral | 90 | MG | 0 | 10 | MG | TID | ||||||
| 117763526 | 11776352 | 10 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 1500 | MG | 0 | 100 | MG | QD | ||||||
| 117763526 | 11776352 | 11 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 85.71 | MG/M2 | 0 | 400 | MG/M**2 | |||||||
| 117763526 | 11776352 | 12 | C | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 19836.67 | MG | 0 | 80 | MG | QD | ||||||
| 117763526 | 11776352 | 13 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 90 | MG | 0 | 30 | MG | QD | ||||||
| 117763526 | 11776352 | 14 | C | LOPERAMIDE | LOPERAMIDE | 1 | Oral | 0 | 2 | MG | |||||||||
| 117763526 | 11776352 | 15 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 2000 MG | 495916.67 | MG | 0 | 1000 | MG | BID | |||||
| 117763526 | 11776352 | 16 | C | NYSTATIN/NYSTATIN/LIPOSOME | 2 | Oral | 20 | MG | 0 | 1 | ML | QID | |||||||
| 117763526 | 11776352 | 17 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 440 | MG | 0 | 40 | MG | QD | ||||||
| 117763526 | 11776352 | 18 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 48 | MG | 0 | 8 | MG | BID | ||||||
| 117763526 | 11776352 | 19 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 9918.33 | MG | 0 | 40 | MG | QD | ||||||
| 117763526 | 11776352 | 20 | C | TINZAPARIN/TINZAPARIN SODIUM | 2 | Subcutaneous | 170000 | IU | 0 | 17000 | IU | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117763526 | 11776352 | 1 | Colorectal cancer |
| 117763526 | 11776352 | 2 | Colorectal cancer |
| 117763526 | 11776352 | 3 | Colorectal cancer |
| 117763526 | 11776352 | 4 | Hypertension |
| 117763526 | 11776352 | 5 | Infection prophylaxis |
| 117763526 | 11776352 | 6 | Mucosal inflammation |
| 117763526 | 11776352 | 7 | Oral candidiasis |
| 117763526 | 11776352 | 8 | Prophylaxis of nausea and vomiting |
| 117763526 | 11776352 | 9 | Prophylaxis of nausea and vomiting |
| 117763526 | 11776352 | 10 | Infection prophylaxis |
| 117763526 | 11776352 | 11 | Colorectal cancer |
| 117763526 | 11776352 | 12 | Type 2 diabetes mellitus |
| 117763526 | 11776352 | 13 | Prophylaxis against gastrointestinal ulcer |
| 117763526 | 11776352 | 14 | Diarrhoea |
| 117763526 | 11776352 | 15 | Type 2 diabetes mellitus |
| 117763526 | 11776352 | 16 | Oral candidiasis |
| 117763526 | 11776352 | 17 | Prophylaxis |
| 117763526 | 11776352 | 18 | Prophylaxis of nausea and vomiting |
| 117763526 | 11776352 | 19 | Prophylaxis |
| 117763526 | 11776352 | 20 | Deep vein thrombosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117763526 | 11776352 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117763526 | 11776352 | Pyrexia | |
| 117763526 | 11776352 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 117763526 | 11776352 | 1 | 20150909 | 0 | ||
| 117763526 | 11776352 | 2 | 20150909 | 0 | ||
| 117763526 | 11776352 | 3 | 20150907 | 0 | ||
| 117763526 | 11776352 | 4 | 20150107 | 0 | ||
| 117763526 | 11776352 | 5 | 20150828 | 20150902 | 0 | |
| 117763526 | 11776352 | 6 | 20150907 | 0 | ||
| 117763526 | 11776352 | 7 | 20150902 | 0 | ||
| 117763526 | 11776352 | 8 | 20150909 | 0 | ||
| 117763526 | 11776352 | 9 | 20150909 | 0 | ||
| 117763526 | 11776352 | 10 | 20150828 | 0 | ||
| 117763526 | 11776352 | 11 | 20150909 | 0 | ||
| 117763526 | 11776352 | 12 | 20150107 | 0 | ||
| 117763526 | 11776352 | 13 | 20150909 | 0 | ||
| 117763526 | 11776352 | 14 | 20150909 | 0 | ||
| 117763526 | 11776352 | 15 | 20150107 | 0 | ||
| 117763526 | 11776352 | 16 | 20150907 | 0 | ||
| 117763526 | 11776352 | 17 | 20150901 | 0 | ||
| 117763526 | 11776352 | 18 | 20150909 | 0 | ||
| 117763526 | 11776352 | 19 | 20150107 | 0 | ||
| 117763526 | 11776352 | 20 | 20150902 | 0 |