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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1231492612 | 12314926 | 12 | F | 20111202 | 20160914 | 20160428 | 20160921 | EXP | PHHY2011CA108907 | SANDOZ | 70.07 | YR | F | Y | 76.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1231492612 | 12314926 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, EVERY FOUR WEEKS | U | 0 | 150 | MG | VIAL | ||||||
| 1231492612 | 12314926 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY FOUR WEEKS | U | 0 | 300 | MG | VIAL | ||||||
| 1231492612 | 12314926 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 18 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0062 | 0 | VIAL | |||||||
| 1231492612 | 12314926 | 19 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B | 0 | VIAL | |||||||
| 1231492612 | 12314926 | 20 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F | 0 | VIAL | |||||||
| 1231492612 | 12314926 | 21 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 22 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 0 | VIAL | |||||||
| 1231492612 | 12314926 | 23 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 1231492612 | 12314926 | 24 | SS | SEEBRI BREEZHALER | GLYCOPYRROLATE | 1 | Respiratory (inhalation) | 1 DF (50 UG), QD | U | 0 | 1 | DF | QD | ||||||
| 1231492612 | 12314926 | 25 | PS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 80336 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1231492612 | 12314926 | 1 | Asthma |
| 1231492612 | 12314926 | 24 | Product used for unknown indication |
| 1231492612 | 12314926 | 25 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1231492612 | 12314926 | LT |
| 1231492612 | 12314926 | HO |
| 1231492612 | 12314926 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1231492612 | 12314926 | Altered state of consciousness | |
| 1231492612 | 12314926 | Anaemia | |
| 1231492612 | 12314926 | Arthritis | |
| 1231492612 | 12314926 | Asthenia | |
| 1231492612 | 12314926 | Asthma | |
| 1231492612 | 12314926 | Back pain | |
| 1231492612 | 12314926 | Bacterial infection | |
| 1231492612 | 12314926 | Balance disorder | |
| 1231492612 | 12314926 | Blood pressure increased | |
| 1231492612 | 12314926 | Bone pain | |
| 1231492612 | 12314926 | Chest pain | |
| 1231492612 | 12314926 | Constipation | |
| 1231492612 | 12314926 | Contusion | |
| 1231492612 | 12314926 | Cough | |
| 1231492612 | 12314926 | Cystitis | |
| 1231492612 | 12314926 | Cytomegalovirus infection | |
| 1231492612 | 12314926 | Decreased appetite | |
| 1231492612 | 12314926 | Drug prescribing error | |
| 1231492612 | 12314926 | Dyspnoea | |
| 1231492612 | 12314926 | Excoriation | |
| 1231492612 | 12314926 | Fall | |
| 1231492612 | 12314926 | Fatigue | |
| 1231492612 | 12314926 | Fibromyalgia | |
| 1231492612 | 12314926 | Fungal infection | |
| 1231492612 | 12314926 | Gait disturbance | |
| 1231492612 | 12314926 | Hypopnoea | |
| 1231492612 | 12314926 | Hypoventilation | |
| 1231492612 | 12314926 | Immune system disorder | |
| 1231492612 | 12314926 | Infection susceptibility increased | |
| 1231492612 | 12314926 | Influenza like illness | |
| 1231492612 | 12314926 | Lethargy | |
| 1231492612 | 12314926 | Limb discomfort | |
| 1231492612 | 12314926 | Lung infection | |
| 1231492612 | 12314926 | Malaise | |
| 1231492612 | 12314926 | Neuropathy peripheral | |
| 1231492612 | 12314926 | Obstructive airways disorder | |
| 1231492612 | 12314926 | Oedema | |
| 1231492612 | 12314926 | Oedema peripheral | |
| 1231492612 | 12314926 | Peripheral swelling | |
| 1231492612 | 12314926 | Pneumonia | |
| 1231492612 | 12314926 | Pulmonary oedema | |
| 1231492612 | 12314926 | Pyrexia | |
| 1231492612 | 12314926 | Rales | |
| 1231492612 | 12314926 | Respiratory rate increased | |
| 1231492612 | 12314926 | Respiratory tract congestion | |
| 1231492612 | 12314926 | Skin atrophy | |
| 1231492612 | 12314926 | Sleep apnoea syndrome | |
| 1231492612 | 12314926 | Sleep disorder | |
| 1231492612 | 12314926 | Soft tissue injury | |
| 1231492612 | 12314926 | Somnolence | |
| 1231492612 | 12314926 | Urinary retention | |
| 1231492612 | 12314926 | Urinary tract infection | |
| 1231492612 | 12314926 | Weight decreased | |
| 1231492612 | 12314926 | Weight increased | |
| 1231492612 | 12314926 | Wheezing | |
| 1231492612 | 12314926 | 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 |
|---|---|---|---|---|---|---|
| 1231492612 | 12314926 | 1 | 20060215 | 0 | ||
| 1231492612 | 12314926 | 2 | 20061214 | 0 | ||
| 1231492612 | 12314926 | 3 | 20121012 | 0 | ||
| 1231492612 | 12314926 | 4 | 201303 | 0 | ||
| 1231492612 | 12314926 | 5 | 20130607 | 0 | ||
| 1231492612 | 12314926 | 6 | 20130705 | 0 | ||
| 1231492612 | 12314926 | 7 | 20130802 | 0 | ||
| 1231492612 | 12314926 | 8 | 20130830 | 0 | ||
| 1231492612 | 12314926 | 9 | 20130927 | 0 | ||
| 1231492612 | 12314926 | 10 | 20131025 | 0 | ||
| 1231492612 | 12314926 | 11 | 20131220 | 0 | ||
| 1231492612 | 12314926 | 12 | 20140314 | 0 | ||
| 1231492612 | 12314926 | 13 | 20140829 | 0 | ||
| 1231492612 | 12314926 | 14 | 20141028 | 0 | ||
| 1231492612 | 12314926 | 15 | 20141121 | 0 | ||
| 1231492612 | 12314926 | 16 | 20150129 | 0 | ||
| 1231492612 | 12314926 | 17 | 20150429 | 0 | ||
| 1231492612 | 12314926 | 18 | 20160322 | 0 | ||
| 1231492612 | 12314926 | 19 | 20160420 | 0 | ||
| 1231492612 | 12314926 | 20 | 20160617 | 0 | ||
| 1231492612 | 12314926 | 21 | 20160713 | 0 | ||
| 1231492612 | 12314926 | 22 | 20160819 | 0 | ||
| 1231492612 | 12314926 | 23 | 20160914 | 0 |