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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117821014 | 11782101 | 4 | F | 2015 | 20160720 | 20151127 | 20160729 | EXP | BR-ABBVIE-15K-020-1507324-00 | ABBVIE | 54.32 | YR | F | Y | 85.00000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117821014 | 11782101 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE, WEEK ZERO | Y | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 117821014 | 11782101 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE, WEEK TWO | Y | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 117821014 | 11782101 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | WEEK 4 | Y | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 117821014 | 11782101 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 117821014 | 11782101 | 5 | SS | MORPHINE | MORPHINE | 1 | Oral | 2 OR 3 TABLETS DAILY | UNKNOWN | 0 | TABLET | ||||||||
| 117821014 | 11782101 | 6 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 7 | C | HIGROTON | CHLORTHALIDONE | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 8 | C | DEPAKENE | VALPROIC ACID | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 9 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 10 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 11 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 12 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | 1 | DF | TABLET | Q12H | |||||||
| 117821014 | 11782101 | 13 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 14 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 | 1 | DF | TABLET | /wk | |||||||
| 117821014 | 11782101 | 15 | C | VITAMIN B NOS | VITAMIN B | 1 | Oral | 0 | 1 | DF | TABLET | /wk | |||||||
| 117821014 | 11782101 | 16 | C | MESACOL MMX | MESALAMINE | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 17 | C | BENESTARE | 2 | Oral | 0 | TABLET | |||||||||||
| 117821014 | 11782101 | 18 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 19 | C | SIMETHICONE (DIMETHICONE) | DIMETHICONE | 1 | Oral | 0 | 45 | GTT | ORAL DROPS | BID | |||||||
| 117821014 | 11782101 | 20 | C | KETOROLAC | KETOROLACKETOROLAC TROMETHAMINE | 1 | Sublingual | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 21 | C | PACO | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Oral | 0 | TABLET | ||||||||||
| 117821014 | 11782101 | 22 | C | TROPINAL | 2 | Oral | 0 | ORAL DROPS | |||||||||||
| 117821014 | 11782101 | 23 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117821014 | 11782101 | 1 | Crohn's disease |
| 117821014 | 11782101 | 5 | Pain |
| 117821014 | 11782101 | 6 | Hypertension |
| 117821014 | 11782101 | 7 | Hypertension |
| 117821014 | 11782101 | 8 | Seizure |
| 117821014 | 11782101 | 9 | Depression |
| 117821014 | 11782101 | 11 | Anxiety |
| 117821014 | 11782101 | 12 | Crohn's disease |
| 117821014 | 11782101 | 13 | Anaemia |
| 117821014 | 11782101 | 14 | Vitamin D deficiency |
| 117821014 | 11782101 | 15 | Anaemia |
| 117821014 | 11782101 | 16 | Crohn's disease |
| 117821014 | 11782101 | 17 | Gastrointestinal disorder |
| 117821014 | 11782101 | 18 | Gastric disorder |
| 117821014 | 11782101 | 19 | Flatulence |
| 117821014 | 11782101 | 20 | Pain |
| 117821014 | 11782101 | 21 | Pain |
| 117821014 | 11782101 | 22 | Pain |
| 117821014 | 11782101 | 23 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117821014 | 11782101 | OT |
| 117821014 | 11782101 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117821014 | 11782101 | Anal fistula | |
| 117821014 | 11782101 | Constipation | |
| 117821014 | 11782101 | Crohn's disease | |
| 117821014 | 11782101 | Depression | |
| 117821014 | 11782101 | Fatigue | |
| 117821014 | 11782101 | Gastrointestinal motility disorder | |
| 117821014 | 11782101 | Hypertension | |
| 117821014 | 11782101 | Hypophagia | |
| 117821014 | 11782101 | Incarcerated hernia | |
| 117821014 | 11782101 | Intestinal obstruction | |
| 117821014 | 11782101 | Lymphadenopathy | |
| 117821014 | 11782101 | Pain | |
| 117821014 | 11782101 | Post procedural complication | |
| 117821014 | 11782101 | Procedural hypertension | |
| 117821014 | 11782101 | Pruritus | |
| 117821014 | 11782101 | Stress | |
| 117821014 | 11782101 | Syncope | |
| 117821014 | 11782101 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 117821014 | 11782101 | 1 | 20151021 | 20151021 | 0 | |
| 117821014 | 11782101 | 2 | 201511 | 201511 | 0 | |
| 117821014 | 11782101 | 3 | 201511 | 201511 | 0 | |
| 117821014 | 11782101 | 4 | 201511 | 201511 | 0 | |
| 117821014 | 11782101 | 5 | 2015 | 0 | ||
| 117821014 | 11782101 | 6 | 2012 | 0 | ||
| 117821014 | 11782101 | 7 | 2012 | 0 | ||
| 117821014 | 11782101 | 8 | 2010 | 0 | ||
| 117821014 | 11782101 | 9 | 2010 | 0 | ||
| 117821014 | 11782101 | 10 | 2013 | 0 | ||
| 117821014 | 11782101 | 11 | 2010 | 0 | ||
| 117821014 | 11782101 | 12 | 2014 | 0 | ||
| 117821014 | 11782101 | 13 | 2013 | 0 | ||
| 117821014 | 11782101 | 14 | 2014 | 0 | ||
| 117821014 | 11782101 | 15 | 2013 | 0 | ||
| 117821014 | 11782101 | 16 | 2014 | 0 | ||
| 117821014 | 11782101 | 17 | 2014 | 0 | ||
| 117821014 | 11782101 | 18 | 2014 | 0 | ||
| 117821014 | 11782101 | 19 | 2014 | 0 | ||
| 117821014 | 11782101 | 20 | 2013 | 0 | ||
| 117821014 | 11782101 | 21 | 2015 | 0 | ||
| 117821014 | 11782101 | 22 | 201606 | 0 | ||
| 117821014 | 11782101 | 23 | 2014 | 0 |