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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 891657218 | 8916572 | 18 | F | 201104 | 20160912 | 20121120 | 20160921 | EXP | CA-ROCHE-GNE312381 | ROCHE | 53.80 | YR | F | Y | 88.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 891657218 | 8916572 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | VIAL | U | S0059B,S0053A,S0062 | 103976 | 300 | MG | SOLUTION FOR INJECTION | |||||
| 891657218 | 8916572 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0053A,S0062 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 891657218 | 8916572 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0053A,S0062 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 891657218 | 8916572 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0053A,S0062 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 891657218 | 8916572 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0053A,S0062 | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 891657218 | 8916572 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0053A,S0062 | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 891657218 | 8916572 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | D | 0 | ||||||||||
| 891657218 | 8916572 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | D | 0 | |||||||||||
| 891657218 | 8916572 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | D | 0 | |||||||||||
| 891657218 | 8916572 | 10 | C | SALBUTAMOL | ALBUTEROL | 1 | Unknown | U | 0 | ||||||||||
| 891657218 | 8916572 | 11 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 891657218 | 8916572 | 12 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | U | 0 | ||||||||||
| 891657218 | 8916572 | 13 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 891657218 | 8916572 | 14 | C | PREDNISONE. | PREDNISONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 891657218 | 8916572 | 1 | Asthma |
| 891657218 | 8916572 | 2 | Pneumonia |
| 891657218 | 8916572 | 7 | Asthma |
| 891657218 | 8916572 | 8 | Pneumonia |
| 891657218 | 8916572 | 9 | Lower respiratory tract infection |
| 891657218 | 8916572 | 10 | Product used for unknown indication |
| 891657218 | 8916572 | 11 | Product used for unknown indication |
| 891657218 | 8916572 | 12 | Product used for unknown indication |
| 891657218 | 8916572 | 13 | Pyrexia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 891657218 | 8916572 | HO |
| 891657218 | 8916572 | OT |
| 891657218 | 8916572 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 891657218 | 8916572 | Arrhythmia | |
| 891657218 | 8916572 | Asthma | |
| 891657218 | 8916572 | Blood pressure increased | |
| 891657218 | 8916572 | Cardiomegaly | |
| 891657218 | 8916572 | Device occlusion | |
| 891657218 | 8916572 | Diarrhoea | |
| 891657218 | 8916572 | Dizziness | |
| 891657218 | 8916572 | Fluid retention | |
| 891657218 | 8916572 | Haematoma | |
| 891657218 | 8916572 | Heart rate irregular | |
| 891657218 | 8916572 | Infection | |
| 891657218 | 8916572 | Lower respiratory tract infection | |
| 891657218 | 8916572 | Lung infection | |
| 891657218 | 8916572 | Malaise | |
| 891657218 | 8916572 | Nausea | |
| 891657218 | 8916572 | Oxygen saturation decreased | |
| 891657218 | 8916572 | Pain in jaw | |
| 891657218 | 8916572 | Pneumonia | |
| 891657218 | 8916572 | Productive cough | |
| 891657218 | 8916572 | Pulmonary congestion | |
| 891657218 | 8916572 | Pulmonary hypertension | |
| 891657218 | 8916572 | Sinus congestion | |
| 891657218 | 8916572 | Syncope | |
| 891657218 | 8916572 | Upper respiratory tract infection | |
| 891657218 | 8916572 | Viral infection | |
| 891657218 | 8916572 | Vomiting | |
| 891657218 | 8916572 | Weight decreased | |
| 891657218 | 8916572 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 891657218 | 8916572 | 1 | 20100624 | 0 | ||
| 891657218 | 8916572 | 2 | 20131210 | 0 | ||
| 891657218 | 8916572 | 3 | 20140408 | 0 | ||
| 891657218 | 8916572 | 4 | 20140805 | 0 | ||
| 891657218 | 8916572 | 6 | 20141223 | 20150205 | 0 | |
| 891657218 | 8916572 | 7 | 20150205 | 0 |