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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1127058019 | 11270580 | 19 | F | 2014 | 20160921 | 20150714 | 20160927 | EXP | PHHY2014CA025312 | SANDOZ | 45.92 | YR | M | Y | 0.00000 | 20160927 | CN | COUNTRY NOT SPECIFIED | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1127058019 | 11270580 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW (EVERY 2 WEEKS) | U | 0 | 375 | MG | VIAL | QOW | |||||
1127058019 | 11270580 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 18 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 19 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 20 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 21 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B | 0 | VIAL | |||||||
1127058019 | 11270580 | 22 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0062 | 0 | VIAL | |||||||
1127058019 | 11270580 | 23 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0062/S0065E | 0 | VIAL | |||||||
1127058019 | 11270580 | 24 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060/S0065E | 0 | VIAL | |||||||
1127058019 | 11270580 | 25 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 0 | VIAL | |||||||
1127058019 | 11270580 | 26 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B | 0 | VIAL | |||||||
1127058019 | 11270580 | 27 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0001E | 0 | VIAL | |||||||
1127058019 | 11270580 | 28 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0068D | 0 | VIAL | |||||||
1127058019 | 11270580 | 29 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F | 0 | VIAL | |||||||
1127058019 | 11270580 | 30 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0068D | 0 | VIAL | |||||||
1127058019 | 11270580 | 31 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003C | 0 | VIAL | |||||||
1127058019 | 11270580 | 32 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0068D | 0 | VIAL | |||||||
1127058019 | 11270580 | 33 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
1127058019 | 11270580 | 34 | PS | PREDNISONE. | PREDNISONE | 1 | Unknown | 80336 | |||||||||||
1127058019 | 11270580 | 35 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 25 MG, QD | 80336 | 25 | MG | QD | |||||||
1127058019 | 11270580 | 36 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, QW | 80336 | 5 | MG | /wk | |||||||
1127058019 | 11270580 | 37 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, QD | 80336 | 20 | MG | QD | |||||||
1127058019 | 11270580 | 38 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 35 MG, QD | 80336 | 35 | MG | QD | |||||||
1127058019 | 11270580 | 39 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, UNK | 80336 | 20 | MG | ||||||||
1127058019 | 11270580 | 40 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 25 MG, QD (TAPERED TO 20 MG OVER 2 WEEKS AND THEN TO 10 MG) | 80336 | 25 | MG | QD | |||||||
1127058019 | 11270580 | 41 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | UNK | 80336 | ||||||||||
1127058019 | 11270580 | 42 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | U | 0 | ||||||||||
1127058019 | 11270580 | 43 | C | ALVESCO | CICLESONIDE | 1 | Unknown | U | 0 | ||||||||||
1127058019 | 11270580 | 44 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
1127058019 | 11270580 | 45 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
1127058019 | 11270580 | 1 | Asthma |
1127058019 | 11270580 | 34 | Wheezing |
1127058019 | 11270580 | 35 | Cough |
1127058019 | 11270580 | 36 | Throat tightness |
1127058019 | 11270580 | 42 | Product used for unknown indication |
1127058019 | 11270580 | 43 | Product used for unknown indication |
1127058019 | 11270580 | 44 | Product used for unknown indication |
1127058019 | 11270580 | 45 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
1127058019 | 11270580 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
1127058019 | 11270580 | Arthralgia | |
1127058019 | 11270580 | Asthma | |
1127058019 | 11270580 | Blood pressure increased | |
1127058019 | 11270580 | Body temperature decreased | |
1127058019 | 11270580 | Bronchitis | |
1127058019 | 11270580 | Chest pain | |
1127058019 | 11270580 | Cough | |
1127058019 | 11270580 | Decreased appetite | |
1127058019 | 11270580 | Dizziness | |
1127058019 | 11270580 | Dizziness postural | |
1127058019 | 11270580 | Dyspnoea exertional | |
1127058019 | 11270580 | Erythema | |
1127058019 | 11270580 | Fall | |
1127058019 | 11270580 | Fractured coccyx | |
1127058019 | 11270580 | Gait disturbance | |
1127058019 | 11270580 | Gastroenteritis viral | |
1127058019 | 11270580 | Headache | |
1127058019 | 11270580 | Heart rate increased | |
1127058019 | 11270580 | Heart rate irregular | |
1127058019 | 11270580 | Herpes zoster | |
1127058019 | 11270580 | Malaise | |
1127058019 | 11270580 | Migraine | |
1127058019 | 11270580 | Neck pain | |
1127058019 | 11270580 | Oxygen saturation decreased | |
1127058019 | 11270580 | Pneumonia | |
1127058019 | 11270580 | Respiratory rate increased | |
1127058019 | 11270580 | Respiratory tract irritation | |
1127058019 | 11270580 | Rib fracture | |
1127058019 | 11270580 | Sneezing | |
1127058019 | 11270580 | Sputum discoloured | |
1127058019 | 11270580 | Swelling | |
1127058019 | 11270580 | Throat tightness | |
1127058019 | 11270580 | Weight decreased | |
1127058019 | 11270580 | Wheezing |
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 |
---|---|---|---|---|---|---|
1127058019 | 11270580 | 1 | 20140227 | 0 | ||
1127058019 | 11270580 | 2 | 20140326 | 0 | ||
1127058019 | 11270580 | 3 | 20140409 | 0 | ||
1127058019 | 11270580 | 4 | 20140521 | 0 | ||
1127058019 | 11270580 | 5 | 20140604 | 0 | ||
1127058019 | 11270580 | 6 | 20140702 | 0 | ||
1127058019 | 11270580 | 7 | 20140716 | 0 | ||
1127058019 | 11270580 | 8 | 20140813 | 0 | ||
1127058019 | 11270580 | 9 | 20140827 | 0 | ||
1127058019 | 11270580 | 10 | 20141217 | 0 | ||
1127058019 | 11270580 | 11 | 20141230 | 0 | ||
1127058019 | 11270580 | 12 | 20150114 | 0 | ||
1127058019 | 11270580 | 13 | 20150129 | 0 | ||
1127058019 | 11270580 | 14 | 20150225 | 0 | ||
1127058019 | 11270580 | 15 | 20150311 | 0 | ||
1127058019 | 11270580 | 16 | 20150325 | 0 | ||
1127058019 | 11270580 | 17 | 20150506 | 0 | ||
1127058019 | 11270580 | 18 | 20150603 | 0 | ||
1127058019 | 11270580 | 19 | 20150715 | 0 | ||
1127058019 | 11270580 | 20 | 20151202 | 0 | ||
1127058019 | 11270580 | 21 | 20160127 | 0 | ||
1127058019 | 11270580 | 22 | 20160224 | 0 | ||
1127058019 | 11270580 | 23 | 20160309 | 0 | ||
1127058019 | 11270580 | 24 | 20160323 | 0 | ||
1127058019 | 11270580 | 25 | 20160504 | 0 | ||
1127058019 | 11270580 | 26 | 20160518 | 0 | ||
1127058019 | 11270580 | 27 | 20160601 | 0 | ||
1127058019 | 11270580 | 28 | 20160615 | 0 | ||
1127058019 | 11270580 | 29 | 20160629 | 0 | ||
1127058019 | 11270580 | 30 | 20160713 | 0 | ||
1127058019 | 11270580 | 31 | 20160825 | 0 | ||
1127058019 | 11270580 | 32 | 20160907 | 0 | ||
1127058019 | 11270580 | 33 | 20160921 | 0 | ||
1127058019 | 11270580 | 35 | 20140627 | 0 | ||
1127058019 | 11270580 | 37 | 20140827 | 0 | ||
1127058019 | 11270580 | 38 | 20141022 | 0 | ||
1127058019 | 11270580 | 39 | 20150426 | 0 |