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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1206814310 | 12068143 | 10 | F | 201508 | 20160825 | 20160211 | 20160829 | EXP | CA-ROCHE-1629781 | ROCHE | 58.44 | YR | M | Y | 0.00000 | 20160829 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1206814310 | 12068143 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 4- 3758MG X 45- FOR INDUCTION, NOT FOR MAINTENANCE?ON HOLD | Y | 103705 | 800 | MG | SOLUTION FOR INFUSION | ||||||
| 1206814310 | 12068143 | 2 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | U | 0 | 200 | MG | BID | |||||||
| 1206814310 | 12068143 | 3 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | |||||||||
| 1206814310 | 12068143 | 4 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Oral | 0 | 50 | MG | |||||||||
| 1206814310 | 12068143 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 1206814310 | 12068143 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | |||||||||||
| 1206814310 | 12068143 | 7 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 1206814310 | 12068143 | 8 | C | TESTOSTERONE. | TESTOSTERONE | 1 | 0 | ||||||||||||
| 1206814310 | 12068143 | 9 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | 0 | ||||||||||||
| 1206814310 | 12068143 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 1206814310 | 12068143 | 11 | C | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 1206814310 | 12068143 | 12 | C | ALTACE | RAMIPRIL | 1 | Unknown | 0 | 2.5 | MG | QD | ||||||||
| 1206814310 | 12068143 | 13 | C | SELENIUM | SELENIUM | 1 | 0 | ||||||||||||
| 1206814310 | 12068143 | 14 | C | LOSEC | OMEPRAZOLE | 1 | Unknown | 0 | 20 | MG | QD | ||||||||
| 1206814310 | 12068143 | 15 | C | ALTACE | RAMIPRIL | 1 | Unknown | 0 | 2.5 | MG | QD | ||||||||
| 1206814310 | 12068143 | 16 | C | SEPTRA SS | 2 | Unknown | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1206814310 | 12068143 | 1 | Vasculitis |
| 1206814310 | 12068143 | 2 | Product used for unknown indication |
| 1206814310 | 12068143 | 3 | Premedication |
| 1206814310 | 12068143 | 4 | Premedication |
| 1206814310 | 12068143 | 5 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1206814310 | 12068143 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1206814310 | 12068143 | Anosmia | |
| 1206814310 | 12068143 | Antineutrophil cytoplasmic antibody increased | |
| 1206814310 | 12068143 | Arthralgia | |
| 1206814310 | 12068143 | Aspergillus infection | |
| 1206814310 | 12068143 | Aspergillus test positive | |
| 1206814310 | 12068143 | Back pain | |
| 1206814310 | 12068143 | Blood creatinine increased | |
| 1206814310 | 12068143 | Blood urine present | |
| 1206814310 | 12068143 | C-reactive protein increased | |
| 1206814310 | 12068143 | Campylobacter infection | |
| 1206814310 | 12068143 | Computerised tomogram thorax abnormal | |
| 1206814310 | 12068143 | Cough | |
| 1206814310 | 12068143 | Dyspnoea | |
| 1206814310 | 12068143 | Erythema | |
| 1206814310 | 12068143 | Eye haemorrhage | |
| 1206814310 | 12068143 | Granulomatosis with polyangiitis | |
| 1206814310 | 12068143 | Haemoglobin decreased | |
| 1206814310 | 12068143 | Herpes simplex | |
| 1206814310 | 12068143 | Ill-defined disorder | |
| 1206814310 | 12068143 | Lung infection | |
| 1206814310 | 12068143 | Musculoskeletal stiffness | |
| 1206814310 | 12068143 | Myalgia | |
| 1206814310 | 12068143 | Nephrolithiasis | |
| 1206814310 | 12068143 | Nephropathy | |
| 1206814310 | 12068143 | Nerve compression | |
| 1206814310 | 12068143 | Nodule | |
| 1206814310 | 12068143 | Protein urine present | |
| 1206814310 | 12068143 | Pyrexia | |
| 1206814310 | 12068143 | Red blood cell sedimentation rate increased | |
| 1206814310 | 12068143 | Red blood cells urine | |
| 1206814310 | 12068143 | Spinal disorder | |
| 1206814310 | 12068143 | Splinter | |
| 1206814310 | 12068143 | Vasculitis | |
| 1206814310 | 12068143 | White blood cell count increased | |
| 1206814310 | 12068143 | X-ray abnormal |
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 |
|---|---|---|---|---|---|---|
| 1206814310 | 12068143 | 1 | 20150723 | 0 | ||
| 1206814310 | 12068143 | 3 | 20150723 | 0 | ||
| 1206814310 | 12068143 | 4 | 20150723 | 0 | ||
| 1206814310 | 12068143 | 5 | 20150723 | 0 | ||
| 1206814310 | 12068143 | 6 | 1994 | 0 |