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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125211801 | 12521180 | 1 | I | 20141231 | 20141231 | 20160701 | 20160701 | EXP | PHHY2014CA170922 | SANDOZ | 61.60 | YR | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125211801 | 12521180 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | 0 | 375 | MG | VIAL | QOW | |||||
| 125211801 | 12521180 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 125211801 | 12521180 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 125211801 | 12521180 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 125211801 | 12521180 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 125211801 | 12521180 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 125211801 | 12521180 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 125211801 | 12521180 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 125211801 | 12521180 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 125211801 | 12521180 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 0 | VIAL | |||||||
| 125211801 | 12521180 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B | 0 | VIAL | |||||||
| 125211801 | 12521180 | 12 | PS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, QID | U | 80336 | 5 | MG | QID | ||||||
| 125211801 | 12521180 | 13 | C | BRICANYL | TERBUTALINE SULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125211801 | 12521180 | 14 | C | ZENHALE | FORMOTEROL FUMARATEMOMETASONE FUROATE | 1 | Unknown | UNK, QID | 0 | QID | |||||||||
| 125211801 | 12521180 | 15 | C | ZENHALE | FORMOTEROL FUMARATEMOMETASONE FUROATE | 1 | Unknown | UNK, QID | 0 | QID | |||||||||
| 125211801 | 12521180 | 16 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 125211801 | 12521180 | 17 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | 2 DF, QD | U | 0 | 2 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125211801 | 12521180 | 1 | Asthma |
| 125211801 | 12521180 | 12 | Product used for unknown indication |
| 125211801 | 12521180 | 13 | Product used for unknown indication |
| 125211801 | 12521180 | 14 | Product used for unknown indication |
| 125211801 | 12521180 | 16 | Arthralgia |
| 125211801 | 12521180 | 17 | Musculoskeletal pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125211801 | 12521180 | HO |
| 125211801 | 12521180 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125211801 | 12521180 | Arthralgia | |
| 125211801 | 12521180 | Bronchitis | |
| 125211801 | 12521180 | Cough | |
| 125211801 | 12521180 | Crying | |
| 125211801 | 12521180 | Dizziness | |
| 125211801 | 12521180 | Hernia | |
| 125211801 | 12521180 | Hypertension | |
| 125211801 | 12521180 | Infarction | |
| 125211801 | 12521180 | Influenza like illness | |
| 125211801 | 12521180 | Musculoskeletal pain | |
| 125211801 | 12521180 | Myocardial infarction | |
| 125211801 | 12521180 | Oedema peripheral | |
| 125211801 | 12521180 | Pyrexia | |
| 125211801 | 12521180 | Respiratory rate increased | |
| 125211801 | 12521180 | Tachycardia | |
| 125211801 | 12521180 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 125211801 | 12521180 | 1 | 20141217 | 0 | ||
| 125211801 | 12521180 | 2 | 20141231 | 0 | ||
| 125211801 | 12521180 | 3 | 20150114 | 0 | ||
| 125211801 | 12521180 | 4 | 20150128 | 0 | ||
| 125211801 | 12521180 | 5 | 20150211 | 0 | ||
| 125211801 | 12521180 | 6 | 20150326 | 0 | ||
| 125211801 | 12521180 | 7 | 20150506 | 0 | ||
| 125211801 | 12521180 | 8 | 20151230 | 0 | ||
| 125211801 | 12521180 | 9 | 20160127 | 0 | ||
| 125211801 | 12521180 | 10 | 20160413 | 0 | ||
| 125211801 | 12521180 | 11 | 20160511 | 0 |