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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127611191 | 12761119 | 1 | I | 201104 | 20110106 | 20160920 | 20160920 | EXP | PHHY2011CA01392 | SANDOZ | 53.80 | YR | F | Y | 88.00000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127611191 | 12761119 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY 4 WEEKS | Y | 0 | 300 | MG | VIAL | ||||||
| 127611191 | 12761119 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | 0 | VIAL | ||||||||
| 127611191 | 12761119 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | 0 | VIAL | ||||||||
| 127611191 | 12761119 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | 0 | VIAL | ||||||||
| 127611191 | 12761119 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY 4 WEEKS | Y | 0 | 300 | MG | VIAL | ||||||
| 127611191 | 12761119 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | LEFT ARM | Y | S0059B | 0 | VIAL | |||||||
| 127611191 | 12761119 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | RIGHT ARM | Y | S0053A | 0 | VIAL | |||||||
| 127611191 | 12761119 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0062 | 0 | VIAL | |||||||
| 127611191 | 12761119 | 9 | PS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 80336 | ||||||||||
| 127611191 | 12761119 | 10 | C | SALBUTAMOL | ALBUTEROL | 1 | Unknown | U | 0 | ||||||||||
| 127611191 | 12761119 | 11 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 127611191 | 12761119 | 12 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127611191 | 12761119 | 1 | Asthma |
| 127611191 | 12761119 | 2 | Pneumonia |
| 127611191 | 12761119 | 9 | Asthma |
| 127611191 | 12761119 | 10 | Product used for unknown indication |
| 127611191 | 12761119 | 11 | Product used for unknown indication |
| 127611191 | 12761119 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127611191 | 12761119 | HO |
| 127611191 | 12761119 | LT |
| 127611191 | 12761119 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127611191 | 12761119 | Arrhythmia | |
| 127611191 | 12761119 | Asthma | |
| 127611191 | 12761119 | Blood pressure systolic increased | |
| 127611191 | 12761119 | Cardiomegaly | |
| 127611191 | 12761119 | Chest discomfort | |
| 127611191 | 12761119 | Device occlusion | |
| 127611191 | 12761119 | Diarrhoea | |
| 127611191 | 12761119 | Dizziness | |
| 127611191 | 12761119 | Dyspnoea | |
| 127611191 | 12761119 | Erythema | |
| 127611191 | 12761119 | Fluid retention | |
| 127611191 | 12761119 | Haematoma | |
| 127611191 | 12761119 | Heart rate irregular | |
| 127611191 | 12761119 | Infection | |
| 127611191 | 12761119 | Lower respiratory tract infection | |
| 127611191 | 12761119 | Lung infection | |
| 127611191 | 12761119 | Malaise | |
| 127611191 | 12761119 | Nausea | |
| 127611191 | 12761119 | Oxygen saturation increased | |
| 127611191 | 12761119 | Pain | |
| 127611191 | 12761119 | Pain in jaw | |
| 127611191 | 12761119 | Pneumonia | |
| 127611191 | 12761119 | Productive cough | |
| 127611191 | 12761119 | Pulmonary congestion | |
| 127611191 | 12761119 | Pulmonary hypertension | |
| 127611191 | 12761119 | Pyrexia | |
| 127611191 | 12761119 | Respiratory tract infection viral | |
| 127611191 | 12761119 | Sinus congestion | |
| 127611191 | 12761119 | Sputum discoloured | |
| 127611191 | 12761119 | Swelling | |
| 127611191 | 12761119 | Syncope | |
| 127611191 | 12761119 | Upper respiratory tract infection | |
| 127611191 | 12761119 | Vomiting | |
| 127611191 | 12761119 | Weight decreased | |
| 127611191 | 12761119 | 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 |
|---|---|---|---|---|---|---|
| 127611191 | 12761119 | 1 | 20100624 | 0 | ||
| 127611191 | 12761119 | 2 | 20131210 | 0 | ||
| 127611191 | 12761119 | 3 | 20140408 | 0 | ||
| 127611191 | 12761119 | 4 | 20140805 | 0 | ||
| 127611191 | 12761119 | 5 | 20141223 | 20150205 | 0 | |
| 127611191 | 12761119 | 8 | 20160324 | 0 | ||
| 127611191 | 12761119 | 9 | 20150205 | 0 |