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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 830755951 | 8307559 | 51 | F | 2012 | 20160914 | 20111222 | 20160920 | EXP | CA-ROCHE-1023801 | ROCHE | 74.45 | YR | F | Y | 76.00000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 830755951 | 8307559 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | 150 | MG | SOLUTION FOR INJECTION | ||||||
| 830755951 | 8307559 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 830755951 | 8307559 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 18 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 19 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 20 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 21 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 22 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 23 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 830755951 | 8307559 | 24 | SS | SEEBRI | GLYCOPYRRONIUM | 1 | Respiratory (inhalation) | 1 DOSAGE FORM (DF), PUFF | U | NOT REPORTED | 0 | 50 | UG | QD | |||||
| 830755951 | 8307559 | 25 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | NOT REPORTED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 830755951 | 8307559 | 1 | Asthma |
| 830755951 | 8307559 | 24 | Product used for unknown indication |
| 830755951 | 8307559 | 25 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 830755951 | 8307559 | LT |
| 830755951 | 8307559 | HO |
| 830755951 | 8307559 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 830755951 | 8307559 | Anaemia | |
| 830755951 | 8307559 | Arthritis | |
| 830755951 | 8307559 | Asthenia | |
| 830755951 | 8307559 | Asthma | |
| 830755951 | 8307559 | Back pain | |
| 830755951 | 8307559 | Bacterial infection | |
| 830755951 | 8307559 | Balance disorder | |
| 830755951 | 8307559 | Blood pressure increased | |
| 830755951 | 8307559 | Bone pain | |
| 830755951 | 8307559 | Consciousness fluctuating | |
| 830755951 | 8307559 | Constipation | |
| 830755951 | 8307559 | Contusion | |
| 830755951 | 8307559 | Cystitis | |
| 830755951 | 8307559 | Cytomegalovirus infection | |
| 830755951 | 8307559 | Decreased appetite | |
| 830755951 | 8307559 | Drug prescribing error | |
| 830755951 | 8307559 | Excoriation | |
| 830755951 | 8307559 | Fall | |
| 830755951 | 8307559 | Fatigue | |
| 830755951 | 8307559 | Fibromyalgia | |
| 830755951 | 8307559 | Fungaemia | |
| 830755951 | 8307559 | Gait disturbance | |
| 830755951 | 8307559 | Hypopnoea | |
| 830755951 | 8307559 | Hypoventilation | |
| 830755951 | 8307559 | Immune system disorder | |
| 830755951 | 8307559 | Infection susceptibility increased | |
| 830755951 | 8307559 | Influenza like illness | |
| 830755951 | 8307559 | Insomnia | |
| 830755951 | 8307559 | Lethargy | |
| 830755951 | 8307559 | Limb discomfort | |
| 830755951 | 8307559 | Lung infection | |
| 830755951 | 8307559 | Neuropathy peripheral | |
| 830755951 | 8307559 | Obstructive airways disorder | |
| 830755951 | 8307559 | Oedema | |
| 830755951 | 8307559 | Oedema peripheral | |
| 830755951 | 8307559 | Peripheral swelling | |
| 830755951 | 8307559 | Pneumonia | |
| 830755951 | 8307559 | Pulmonary congestion | |
| 830755951 | 8307559 | Pulmonary oedema | |
| 830755951 | 8307559 | Rales | |
| 830755951 | 8307559 | Respiratory rate increased | |
| 830755951 | 8307559 | Skin atrophy | |
| 830755951 | 8307559 | Sleep apnoea syndrome | |
| 830755951 | 8307559 | Soft tissue injury | |
| 830755951 | 8307559 | Somnolence | |
| 830755951 | 8307559 | Urinary retention | |
| 830755951 | 8307559 | Urinary tract infection | |
| 830755951 | 8307559 | Weight decreased | |
| 830755951 | 8307559 | Weight increased | |
| 830755951 | 8307559 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 830755951 | 8307559 | 1 | 20060215 | 0 | ||
| 830755951 | 8307559 | 2 | 20061214 | 0 | ||
| 830755951 | 8307559 | 3 | 20121012 | 0 | ||
| 830755951 | 8307559 | 4 | 201303 | 0 | ||
| 830755951 | 8307559 | 5 | 20130607 | 0 | ||
| 830755951 | 8307559 | 6 | 20130705 | 0 | ||
| 830755951 | 8307559 | 7 | 20130802 | 0 | ||
| 830755951 | 8307559 | 8 | 20130830 | 0 | ||
| 830755951 | 8307559 | 9 | 20130927 | 0 | ||
| 830755951 | 8307559 | 10 | 20131025 | 0 | ||
| 830755951 | 8307559 | 11 | 20131220 | 0 | ||
| 830755951 | 8307559 | 12 | 20140314 | 0 | ||
| 830755951 | 8307559 | 13 | 20140829 | 0 | ||
| 830755951 | 8307559 | 14 | 20141028 | 0 | ||
| 830755951 | 8307559 | 15 | 20141121 | 0 | ||
| 830755951 | 8307559 | 16 | 20150129 | 0 | ||
| 830755951 | 8307559 | 17 | 20150429 | 0 | ||
| 830755951 | 8307559 | 18 | 20160322 | 0 | ||
| 830755951 | 8307559 | 19 | 20160420 | 0 | ||
| 830755951 | 8307559 | 20 | 20160617 | 0 | ||
| 830755951 | 8307559 | 21 | 20160713 | 0 | ||
| 830755951 | 8307559 | 22 | 20160819 | 0 | ||
| 830755951 | 8307559 | 23 | 20160914 | 0 |