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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109963594 | 10996359 | 4 | F | 201401 | 20160825 | 20150408 | 20160829 | EXP | CA-ROCHE-1378706 | ROCHE | 66.12 | YR | M | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109963594 | 10996359 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | FREQUENCY: DAY 1 AND 15 | H06553,H0714,H0762,H0793,N3738 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||
| 109963594 | 10996359 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | H06553,H0714,H0762,H0793,N3738 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 109963594 | 10996359 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | U | 50723 | ||||||||||
| 109963594 | 10996359 | 4 | SS | VALACYCLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | FOR 5 WEEKS | U | 0 | |||||||||
| 109963594 | 10996359 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 109963594 | 10996359 | 6 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 109963594 | 10996359 | 7 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 109963594 | 10996359 | 8 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 9 | C | ALTACE | RAMIPRIL | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 10 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 11 | C | NEURONTIN | GABAPENTIN | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 12 | C | DIAMICRON | GLICLAZIDE | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 13 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 14 | C | BRICANYL | TERBUTALINE SULFATE | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 15 | C | PENNSAID | DICLOFENAC SODIUM | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 16 | C | ASA | ASPIRIN | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 17 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 18 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 0 | CAPSULE | ||||||||||
| 109963594 | 10996359 | 19 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 20 | C | ATIVAN | LORAZEPAM | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 21 | C | EZETROL | EZETIMIBE | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 22 | C | REFRESH PLUS | CARBOXYMETHYLCELLULOSE SODIUM | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 23 | C | NASONEX | MOMETASONE FUROATE | 1 | 0 | ||||||||||||
| 109963594 | 10996359 | 24 | C | LASIX | FUROSEMIDE | 1 | Unknown | 0 | 20 | MG | QD | ||||||||
| 109963594 | 10996359 | 25 | C | PREDNISONE. | PREDNISONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109963594 | 10996359 | 1 | Myositis |
| 109963594 | 10996359 | 3 | Product used for unknown indication |
| 109963594 | 10996359 | 4 | Product used for unknown indication |
| 109963594 | 10996359 | 5 | Premedication |
| 109963594 | 10996359 | 6 | Premedication |
| 109963594 | 10996359 | 7 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109963594 | 10996359 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109963594 | 10996359 | Body temperature decreased | |
| 109963594 | 10996359 | Cytomegalovirus infection | |
| 109963594 | 10996359 | Diastolic dysfunction | |
| 109963594 | 10996359 | Drug ineffective | |
| 109963594 | 10996359 | Heart rate decreased | |
| 109963594 | 10996359 | Infusion related reaction | |
| 109963594 | 10996359 | Off label use | |
| 109963594 | 10996359 | Oxygen saturation decreased | |
| 109963594 | 10996359 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 109963594 | 10996359 | 1 | 20120730 | 0 | ||
| 109963594 | 10996359 | 2 | 20131125 | 0 | ||
| 109963594 | 10996359 | 5 | 20120730 | 20140807 | 0 | |
| 109963594 | 10996359 | 6 | 20120730 | 0 | ||
| 109963594 | 10996359 | 7 | 20120730 | 0 |