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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108701313 | 10870131 | 3 | F | 201409 | 20160810 | 20150226 | 20160812 | EXP | CA-009507513-1502CAN010703 | MERCK | 60.00 | YR | F | Y | 48.00000 | KG | 20160812 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108701313 | 10870131 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | UNK | Y | 20560 | TABLET | ||||||||
| 108701313 | 10870131 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 1000 MG, DAY 1 AND DAY 15 | 0 | SOLUTION FOR INJECTION/INFUSION | |||||||||
| 108701313 | 10870131 | 3 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 | SOLUTION FOR INJECTION/INFUSION | |||||||||
| 108701313 | 10870131 | 4 | SS | HYDROMORPHONE | HYDROMORPHONE | 1 | Unknown | UNK | 0 | ||||||||||
| 108701313 | 10870131 | 5 | SS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | THERAPY DURATION: 122.0 | U | U | 0 | ||||||||
| 108701313 | 10870131 | 6 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 50 MG, UNK | U | U | 0 | 50 | MG | ||||||
| 108701313 | 10870131 | 7 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 650 MG, UNK | U | 0 | 650 | MG | TABLET | ||||||
| 108701313 | 10870131 | 8 | C | DICLOFENAC | DICLOFENAC | 1 | Unknown | UNK | U | 0 | |||||||||
| 108701313 | 10870131 | 9 | C | DIPHENHYDRAMINE HYDROCHLORIDE. | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 108701313 | 10870131 | 10 | C | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 108701313 | 10870131 | 11 | C | LOSEC (omeprazole) | 2 | Unknown | UNK | U | 0 | ||||||||||
| 108701313 | 10870131 | 12 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 108701313 | 10870131 | 13 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 100 MG, UNK | U | 0 | 100 | MG | |||||||
| 108701313 | 10870131 | 14 | C | HYDROXYCHLOROQUINE SULFATE. | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 108701313 | 10870131 | 15 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 108701313 | 10870131 | 16 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 108701313 | 10870131 | 17 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108701313 | 10870131 | 1 | Product used for unknown indication |
| 108701313 | 10870131 | 2 | Rheumatoid arthritis |
| 108701313 | 10870131 | 4 | Analgesic therapy |
| 108701313 | 10870131 | 5 | Neuralgia |
| 108701313 | 10870131 | 6 | Premedication |
| 108701313 | 10870131 | 7 | Premedication |
| 108701313 | 10870131 | 9 | Premedication |
| 108701313 | 10870131 | 10 | Product used for unknown indication |
| 108701313 | 10870131 | 11 | Product used for unknown indication |
| 108701313 | 10870131 | 12 | Product used for unknown indication |
| 108701313 | 10870131 | 13 | Premedication |
| 108701313 | 10870131 | 14 | Product used for unknown indication |
| 108701313 | 10870131 | 15 | Product used for unknown indication |
| 108701313 | 10870131 | 16 | Product used for unknown indication |
| 108701313 | 10870131 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108701313 | 10870131 | LT |
| 108701313 | 10870131 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108701313 | 10870131 | Alopecia | |
| 108701313 | 10870131 | Chest pain | |
| 108701313 | 10870131 | Drug ineffective | |
| 108701313 | 10870131 | Fatigue | |
| 108701313 | 10870131 | Femur fracture | |
| 108701313 | 10870131 | Flushing | |
| 108701313 | 10870131 | Headache | |
| 108701313 | 10870131 | Infusion related reaction | |
| 108701313 | 10870131 | Malaise | |
| 108701313 | 10870131 | Nasopharyngitis | |
| 108701313 | 10870131 | Nausea | |
| 108701313 | 10870131 | Nervousness | |
| 108701313 | 10870131 | Neuralgia | |
| 108701313 | 10870131 | Osteoporosis | |
| 108701313 | 10870131 | Rheumatoid arthritis | |
| 108701313 | 10870131 | Scratch | |
| 108701313 | 10870131 | Sinusitis | |
| 108701313 | 10870131 | Somnolence | |
| 108701313 | 10870131 | Tooth disorder |
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 |
|---|---|---|---|---|---|---|
| 108701313 | 10870131 | 1 | 201409 | 0 | ||
| 108701313 | 10870131 | 2 | 20120919 | 0 | ||
| 108701313 | 10870131 | 4 | 201411 | 0 |