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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112037356 | 11203735 | 6 | F | 201305 | 20160901 | 20150619 | 20160906 | EXP | BR-ABBVIE-15K-020-1409261-00 | ABBVIE | 49.43 | YR | F | Y | 59.00000 | KG | 20160906 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112037356 | 11203735 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 41493XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 112037356 | 11203735 | 2 | C | SALBUTAMOL SULFATE | ALBUTEROL SULFATE | 1 | Oral | 0 | SYRUP | BID | |||||||||
| 112037356 | 11203735 | 3 | C | AEROLIN | ALBUTEROL | 1 | Oral | 0 | QID | ||||||||||
| 112037356 | 11203735 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | TABLET | ||||||||||
| 112037356 | 11203735 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 112037356 | 11203735 | 6 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0 | TABLET | ||||||||||
| 112037356 | 11203735 | 7 | C | AAS | ASPIRIN | 1 | Oral | 0 | TABLET | ||||||||||
| 112037356 | 11203735 | 8 | C | AAS | ASPIRIN | 1 | 0 | ||||||||||||
| 112037356 | 11203735 | 9 | C | AAS | ASPIRIN | 1 | 0 | ||||||||||||
| 112037356 | 11203735 | 10 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 0 | TABLET | ||||||||||
| 112037356 | 11203735 | 11 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 112037356 | 11203735 | 12 | C | HIDANTAL | PHENYTOIN SODIUM | 1 | Oral | 0 | TABLET | ||||||||||
| 112037356 | 11203735 | 13 | C | HIDANTAL | PHENYTOIN SODIUM | 1 | 0 | ||||||||||||
| 112037356 | 11203735 | 14 | C | HIDANTAL | PHENYTOIN SODIUM | 1 | 0 | ||||||||||||
| 112037356 | 11203735 | 15 | C | RISPERIDONE. | RISPERIDONE | 1 | Oral | 0 | TABLET | ||||||||||
| 112037356 | 11203735 | 16 | C | AMYTRIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 112037356 | 11203735 | 17 | C | AMYTRIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112037356 | 11203735 | 1 | Psoriatic arthropathy |
| 112037356 | 11203735 | 2 | Asthma |
| 112037356 | 11203735 | 3 | Asthma |
| 112037356 | 11203735 | 4 | Prophylaxis |
| 112037356 | 11203735 | 5 | Gastric disorder |
| 112037356 | 11203735 | 6 | Depression |
| 112037356 | 11203735 | 7 | Anticoagulant therapy |
| 112037356 | 11203735 | 8 | Venous occlusion |
| 112037356 | 11203735 | 9 | Prophylaxis |
| 112037356 | 11203735 | 10 | Depression |
| 112037356 | 11203735 | 11 | Diabetes mellitus |
| 112037356 | 11203735 | 12 | Cerebral infarction |
| 112037356 | 11203735 | 13 | Seizure |
| 112037356 | 11203735 | 14 | Mental disorder |
| 112037356 | 11203735 | 15 | Depression |
| 112037356 | 11203735 | 16 | Sedative therapy |
| 112037356 | 11203735 | 17 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112037356 | 11203735 | OT |
| 112037356 | 11203735 | LT |
| 112037356 | 11203735 | DS |
| 112037356 | 11203735 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112037356 | 11203735 | Agitation | |
| 112037356 | 11203735 | Anxiety | |
| 112037356 | 11203735 | Arthritis | |
| 112037356 | 11203735 | Asthmatic crisis | |
| 112037356 | 11203735 | Blepharitis | |
| 112037356 | 11203735 | Blood pressure increased | |
| 112037356 | 11203735 | Bronchitis | |
| 112037356 | 11203735 | Burning sensation | |
| 112037356 | 11203735 | Cardiac discomfort | |
| 112037356 | 11203735 | Cerebral infarction | |
| 112037356 | 11203735 | Cerebrovascular accident | |
| 112037356 | 11203735 | Chest discomfort | |
| 112037356 | 11203735 | Depression | |
| 112037356 | 11203735 | Dermatitis | |
| 112037356 | 11203735 | Dyspnoea | |
| 112037356 | 11203735 | Hypertension | |
| 112037356 | 11203735 | Intracranial mass | |
| 112037356 | 11203735 | Joint swelling | |
| 112037356 | 11203735 | Localised oedema | |
| 112037356 | 11203735 | Malaise | |
| 112037356 | 11203735 | Memory impairment | |
| 112037356 | 11203735 | Mental disorder | |
| 112037356 | 11203735 | Mental impairment | |
| 112037356 | 11203735 | Nervousness | |
| 112037356 | 11203735 | Pain | |
| 112037356 | 11203735 | Psoriasis | |
| 112037356 | 11203735 | Seizure | |
| 112037356 | 11203735 | Skin haemorrhage | |
| 112037356 | 11203735 | Speech disorder | |
| 112037356 | 11203735 | Suicidal ideation | |
| 112037356 | 11203735 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 112037356 | 11203735 | 1 | 20121130 | 0 | ||
| 112037356 | 11203735 | 6 | 2001 | 0 | ||
| 112037356 | 11203735 | 7 | 201407 | 0 | ||
| 112037356 | 11203735 | 10 | 2005 | 0 | ||
| 112037356 | 11203735 | 11 | 2007 | 0 | ||
| 112037356 | 11203735 | 12 | 201407 | 0 | ||
| 112037356 | 11203735 | 15 | 201506 | 0 | ||
| 112037356 | 11203735 | 16 | 2004 | 0 |