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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122763442 | 12276344 | 2 | F | 20150617 | 20160714 | 20160418 | 20160715 | EXP | DE-ROCHE-1599688 | ROCHE | 0.00 | F | Y | 0.00000 | 20160715 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122763442 | 12276344 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE OF RITUXIMAB BEFORE SAE IS 10/DEC/2015. | 103705 | 630 | MG | SOLUTION FOR INFUSION | |||||||
| 122763442 | 12276344 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | U | 0 | QOW | |||||||||
| 122763442 | 12276344 | 3 | SS | DOXORUBICINE | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 122763442 | 12276344 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 122763442 | 12276344 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | DATE OF LAST DOSE BEFORE SAE 24/JUN/2015 | U | 0 | |||||||||
| 122763442 | 12276344 | 6 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | U | 0 | ||||||||||
| 122763442 | 12276344 | 7 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 0 | 2.5 | MG | QD | ||||||||
| 122763442 | 12276344 | 8 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | QD | ||||||||||
| 122763442 | 12276344 | 9 | C | ENOXAPARIN SODIUM. | ENOXAPARIN SODIUM | 1 | Subcutaneous | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122763442 | 12276344 | 1 | B-cell lymphoma |
| 122763442 | 12276344 | 2 | B-cell lymphoma |
| 122763442 | 12276344 | 3 | B-cell lymphoma |
| 122763442 | 12276344 | 4 | B-cell lymphoma |
| 122763442 | 12276344 | 5 | B-cell lymphoma |
| 122763442 | 12276344 | 6 | B-cell lymphoma |
| 122763442 | 12276344 | 7 | Cardiac failure |
| 122763442 | 12276344 | 8 | Prophylaxis against gastrointestinal ulcer |
| 122763442 | 12276344 | 9 | Pulmonary embolism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122763442 | 12276344 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122763442 | 12276344 | Hypotension | |
| 122763442 | 12276344 | Interstitial lung disease | |
| 122763442 | 12276344 | Malaise | |
| 122763442 | 12276344 | Pneumonia aspiration | |
| 122763442 | 12276344 | Pyrexia | |
| 122763442 | 12276344 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 122763442 | 12276344 | 1 | 20150407 | 20150710 | 0 | |
| 122763442 | 12276344 | 2 | 20150409 | 20150624 | 0 | |
| 122763442 | 12276344 | 3 | 20150409 | 20150624 | 0 | |
| 122763442 | 12276344 | 4 | 20150409 | 20150507 | 0 | |
| 122763442 | 12276344 | 5 | 20150407 | 20150628 | 0 | |
| 122763442 | 12276344 | 6 | 20150409 | 20150629 | 0 | |
| 122763442 | 12276344 | 8 | 2015 | 0 | ||
| 122763442 | 12276344 | 9 | 201503 | 0 |