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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93695314 | 9369531 | 4 | F | 2013 | 20160830 | 20130626 | 20160909 | EXP | BR-ROCHE-1239895 | ROCHE | 48.91 | YR | F | Y | 54.00000 | KG | 20160909 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93695314 | 9369531 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 28 TO 28 DAYS | UNKNOWN | 103976 | 2 | DF | SOLUTION FOR INJECTION | /month | |||||
| 93695314 | 9369531 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, QMO | UNKNOWN | 103976 | 300 | MG | SOLUTION FOR INJECTION | /month | |||||
| 93695314 | 9369531 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | UNKNOWN | 103976 | SOLUTION FOR INJECTION | ||||||||
| 93695314 | 9369531 | 4 | C | ALENIA (BRAZIL) | BUDESONIDEFORMOTEROL FUMARATE | 1 | Unknown | UNK, 8 TO 8 HOURS | 0 | ||||||||||
| 93695314 | 9369531 | 5 | C | ALENIA (BRAZIL) | BUDESONIDEFORMOTEROL FUMARATE | 1 | Unknown | 1 DF, JET (12/12 HRS) | 0 | 1 | DF | ||||||||
| 93695314 | 9369531 | 6 | C | AEROLIN | ALBUTEROL | 1 | Unknown | 2 DF, 2 JETS (4 TO 4 HOURS) | 0 | 2 | DF | ||||||||
| 93695314 | 9369531 | 7 | C | BUDESONIDE. | BUDESONIDE | 1 | Unknown | 1 DF,12 TO 12 HOURS | 0 | 1 | DF | CAPSULE | |||||||
| 93695314 | 9369531 | 8 | C | BUDESONIDE. | BUDESONIDE | 1 | Unknown | 1 DF, JET 12 TO 12 HOURS | 0 | 1 | DF | CAPSULE | |||||||
| 93695314 | 9369531 | 9 | C | BAMIFIX | BAMIFYLLINE HYDROCHLORIDE | 1 | Unknown | 300 MG, 12 TO 12 HOURS | 0 | 300 | MG | CAPSULE | |||||||
| 93695314 | 9369531 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK UNK, QD | U | 0 | TABLET | QD | |||||||
| 93695314 | 9369531 | 11 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 50 MG, EVERY MORNING | U | 0 | 50 | MG | TABLET | ||||||
| 93695314 | 9369531 | 12 | C | APRESOLINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 93695314 | 9369531 | 13 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 1 DF, (BEFORE SLEEP 1 TABLET) | 0 | 1 | DF | TABLET | |||||||
| 93695314 | 9369531 | 14 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | 2 DF, (2 TABLETS) | 0 | 2 | DF | TABLET | |||||||
| 93695314 | 9369531 | 15 | C | ENALAPRIL | ENALAPRIL | 1 | Unknown | 10 OT, UNK | 0 | TABLET | |||||||||
| 93695314 | 9369531 | 16 | C | LASIX | FUROSEMIDE | 1 | Unknown | 40 OT, UNK | 0 | TABLET | |||||||||
| 93695314 | 9369531 | 17 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 850 OT, UNK | 0 | TABLET | |||||||||
| 93695314 | 9369531 | 18 | C | Glibenclamide | GLYBURIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 93695314 | 9369531 | 19 | C | LUMIGAN | BIMATOPROST | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 93695314 | 9369531 | 20 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 2 DF, UNK | 0 | 2 | DF | TABLET | |||||||
| 93695314 | 9369531 | 21 | C | SALBUTAMOL | ALBUTEROL | 1 | Unknown | SPORADIC | 0 | TABLET | |||||||||
| 93695314 | 9369531 | 22 | C | DIGESAN | BROMOPRIDE | 1 | Unknown | 0 | |||||||||||
| 93695314 | 9369531 | 23 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | 80 | MG | |||||||||
| 93695314 | 9369531 | 24 | C | INSULIN REGULAR | INSULIN NOS | 1 | Unknown | 0 | |||||||||||
| 93695314 | 9369531 | 25 | C | RIVOTRIL | CLONAZEPAM | 1 | Unknown | 0 | 2 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 93695314 | 9369531 | 1 | Asthma |
| 93695314 | 9369531 | 4 | Asthma |
| 93695314 | 9369531 | 6 | Product used for unknown indication |
| 93695314 | 9369531 | 7 | Asthma |
| 93695314 | 9369531 | 9 | Product used for unknown indication |
| 93695314 | 9369531 | 10 | Bronchial disorder |
| 93695314 | 9369531 | 11 | Asthma |
| 93695314 | 9369531 | 12 | Product used for unknown indication |
| 93695314 | 9369531 | 13 | Product used for unknown indication |
| 93695314 | 9369531 | 14 | Product used for unknown indication |
| 93695314 | 9369531 | 15 | Product used for unknown indication |
| 93695314 | 9369531 | 16 | Product used for unknown indication |
| 93695314 | 9369531 | 17 | Diabetes mellitus |
| 93695314 | 9369531 | 18 | Product used for unknown indication |
| 93695314 | 9369531 | 19 | Glaucoma |
| 93695314 | 9369531 | 20 | Depression |
| 93695314 | 9369531 | 21 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 93695314 | 9369531 | OT |
| 93695314 | 9369531 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 93695314 | 9369531 | Abdominal pain upper | |
| 93695314 | 9369531 | Apnoea | |
| 93695314 | 9369531 | Asthma | |
| 93695314 | 9369531 | Back disorder | |
| 93695314 | 9369531 | Cataract | |
| 93695314 | 9369531 | Diabetes mellitus | |
| 93695314 | 9369531 | Diabetic foot | |
| 93695314 | 9369531 | Dyskinesia oesophageal | |
| 93695314 | 9369531 | Dyspnoea | |
| 93695314 | 9369531 | Erysipelas | |
| 93695314 | 9369531 | Fatigue | |
| 93695314 | 9369531 | Fluid retention | |
| 93695314 | 9369531 | Gait disturbance | |
| 93695314 | 9369531 | Gastrooesophageal reflux disease | |
| 93695314 | 9369531 | Hypertension | |
| 93695314 | 9369531 | Insomnia | |
| 93695314 | 9369531 | Limb injury | |
| 93695314 | 9369531 | Malaise | |
| 93695314 | 9369531 | Oesophagitis | |
| 93695314 | 9369531 | Osteoarthritis | |
| 93695314 | 9369531 | Pneumonia | |
| 93695314 | 9369531 | Pneumonia bacterial | |
| 93695314 | 9369531 | Pulmonary oedema | |
| 93695314 | 9369531 | 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 |
|---|---|---|---|---|---|---|
| 93695314 | 9369531 | 1 | 20110613 | 0 | ||
| 93695314 | 9369531 | 2 | 20130618 | 0 | ||
| 93695314 | 9369531 | 3 | 20130618 | 0 | ||
| 93695314 | 9369531 | 4 | 2007 | 0 | ||
| 93695314 | 9369531 | 5 | 2008 | 0 | ||
| 93695314 | 9369531 | 7 | 2007 | 0 | ||
| 93695314 | 9369531 | 8 | 2008 | 0 | ||
| 93695314 | 9369531 | 9 | 2006 | 0 | ||
| 93695314 | 9369531 | 10 | 2006 | 0 | ||
| 93695314 | 9369531 | 11 | 20060601 | 0 | ||
| 93695314 | 9369531 | 12 | 2011 | 0 | ||
| 93695314 | 9369531 | 13 | 2012 | 0 | ||
| 93695314 | 9369531 | 14 | 2006 | 0 | ||
| 93695314 | 9369531 | 15 | 2007 | 0 | ||
| 93695314 | 9369531 | 16 | 2007 | 0 | ||
| 93695314 | 9369531 | 17 | 2007 | 0 | ||
| 93695314 | 9369531 | 18 | 2011 | 0 | ||
| 93695314 | 9369531 | 19 | 2007 | 0 | ||
| 93695314 | 9369531 | 20 | 2006 | 0 | ||
| 93695314 | 9369531 | 21 | 2007 | 0 | ||
| 93695314 | 9369531 | 22 | 2007 | 0 | ||
| 93695314 | 9369531 | 23 | 2007 | 0 | ||
| 93695314 | 9369531 | 24 | 2012 | 0 | ||
| 93695314 | 9369531 | 25 | 2007 | 0 |