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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121475925 | 12147592 | 5 | F | 20160126 | 20160804 | 20160304 | 20160812 | EXP | US-TEVA-633065ACC | TEVA | 68.88 | YR | F | Y | 0.00000 | 20160812 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121475925 | 12147592 | 1 | PS | BENDAMUSTINE HYDROCHLORIDE. | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 22249 | 178 | MG | POWDER FOR INJECTION | ||||||||
| 121475925 | 12147592 | 2 | SS | BENDAMUSTINE HYDROCHLORIDE. | BENDAMUSTINE HYDROCHLORIDE | 1 | MOST RECENT DOSE | 22249 | |||||||||||
| 121475925 | 12147592 | 3 | SS | RITUXIMAB | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 3039781 | 0 | 743 | MG | SOLUTION FOR INFUSION | |||||||
| 121475925 | 12147592 | 4 | C | INSULIN ASPART | INSULIN ASPART | 1 | Unknown | 02-20 UNITS BEFORE MEALS | 0 | ||||||||||
| 121475925 | 12147592 | 5 | C | INSULIN DETEMIR | INSULIN DETEMIR | 1 | Subcutaneous | 0 | QD | ||||||||||
| 121475925 | 12147592 | 6 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | 0 | |||||||||||
| 121475925 | 12147592 | 7 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 0 | |||||||||||
| 121475925 | 12147592 | 8 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 0 | |||||||||||
| 121475925 | 12147592 | 9 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 121475925 | 12147592 | 10 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 50 MILLIGRAM DAILY; | 0 | 50 | MG | QD | |||||||
| 121475925 | 12147592 | 11 | C | NYSTATIN. | NYSTATIN | 1 | Topical | 0 | |||||||||||
| 121475925 | 12147592 | 12 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 0 | 1 | DF | TABLET | ||||||||
| 121475925 | 12147592 | 13 | C | SITAGLIPTIN | SITAGLIPTIN | 1 | Oral | 100 MILLIGRAM DAILY; | 0 | 100 | MG | QD | |||||||
| 121475925 | 12147592 | 14 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | 0 | 4 | MG | |||||||||
| 121475925 | 12147592 | 15 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | 0 | 50 | MG | |||||||||
| 121475925 | 12147592 | 16 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 150 MILLIGRAM DAILY; | 0 | 150 | MG | QD | |||||||
| 121475925 | 12147592 | 17 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 0 | 5 | MG | |||||||||
| 121475925 | 12147592 | 18 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Oral | 0 | 145 | MG | |||||||||
| 121475925 | 12147592 | 19 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | Unknown | FLONASE | 0 | ||||||||||
| 121475925 | 12147592 | 20 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 1 | DF | TABLET | ||||||||
| 121475925 | 12147592 | 21 | C | ACRIVASTINE | ACRIVASTINE | 1 | Oral | 0 | 1 | DF | TABLET | ||||||||
| 121475925 | 12147592 | 22 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | TABLET | TIW | |||||||||
| 121475925 | 12147592 | 23 | C | FLONASE /00908302/ | MOMETASONE FUROATE | 1 | Nasal | 1 SPRAY | 0 | 1 | DF | BIW | |||||||
| 121475925 | 12147592 | 24 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 10 MILLIGRAM DAILY; | 0 | 10 | MG | QD | |||||||
| 121475925 | 12147592 | 25 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | |||||||||
| 121475925 | 12147592 | 26 | C | CLARITIN | LORATADINE | 1 | Oral | 0 | 10 | MG | |||||||||
| 121475925 | 12147592 | 27 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 8 MILLIGRAM DAILY; | 0 | 8 | MG | QD | |||||||
| 121475925 | 12147592 | 28 | C | GOLYTELY | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDESODIUM SULFATE ANHYDROUS | 1 | Oral | 0 | 4000 | ML |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121475925 | 12147592 | 1 | Mantle cell lymphoma |
| 121475925 | 12147592 | 3 | Mantle cell lymphoma |
| 121475925 | 12147592 | 4 | Product used for unknown indication |
| 121475925 | 12147592 | 5 | Product used for unknown indication |
| 121475925 | 12147592 | 6 | Product used for unknown indication |
| 121475925 | 12147592 | 7 | Product used for unknown indication |
| 121475925 | 12147592 | 8 | Product used for unknown indication |
| 121475925 | 12147592 | 9 | Product used for unknown indication |
| 121475925 | 12147592 | 10 | Hypertension |
| 121475925 | 12147592 | 11 | Product used for unknown indication |
| 121475925 | 12147592 | 12 | Hyperlipidaemia |
| 121475925 | 12147592 | 13 | Diabetes mellitus |
| 121475925 | 12147592 | 14 | Fibromyalgia |
| 121475925 | 12147592 | 15 | Headache |
| 121475925 | 12147592 | 16 | Mood swings |
| 121475925 | 12147592 | 17 | Hypertension |
| 121475925 | 12147592 | 18 | Hyperlipidaemia |
| 121475925 | 12147592 | 19 | Product used for unknown indication |
| 121475925 | 12147592 | 20 | Headache |
| 121475925 | 12147592 | 21 | Nausea |
| 121475925 | 12147592 | 22 | Infection prophylaxis |
| 121475925 | 12147592 | 23 | Hypersensitivity |
| 121475925 | 12147592 | 24 | Hypersensitivity |
| 121475925 | 12147592 | 25 | Viral infection |
| 121475925 | 12147592 | 26 | Hypersensitivity |
| 121475925 | 12147592 | 27 | Nausea |
| 121475925 | 12147592 | 28 | Colonoscopy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121475925 | 12147592 | OT |
| 121475925 | 12147592 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121475925 | 12147592 | Atrial fibrillation | |
| 121475925 | 12147592 | Chest pain | |
| 121475925 | 12147592 | Pleural effusion | |
| 121475925 | 12147592 | Pneumonia | |
| 121475925 | 12147592 | Septic shock |
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 |
|---|---|---|---|---|---|---|
| 121475925 | 12147592 | 1 | 20141106 | 20150327 | 0 | |
| 121475925 | 12147592 | 2 | 20151230 | 0 | ||
| 121475925 | 12147592 | 3 | 20141105 | 20151230 | 0 | |
| 121475925 | 12147592 | 10 | 20141027 | 0 | ||
| 121475925 | 12147592 | 12 | 20141027 | 0 | ||
| 121475925 | 12147592 | 13 | 20141127 | 0 | ||
| 121475925 | 12147592 | 14 | 20141027 | 0 | ||
| 121475925 | 12147592 | 15 | 20141107 | 0 | ||
| 121475925 | 12147592 | 16 | 20141027 | 0 | ||
| 121475925 | 12147592 | 17 | 20141027 | 0 | ||
| 121475925 | 12147592 | 18 | 20141027 | 0 | ||
| 121475925 | 12147592 | 20 | 20141109 | 0 | ||
| 121475925 | 12147592 | 21 | 20141105 | 0 | ||
| 121475925 | 12147592 | 22 | 20141202 | 0 | ||
| 121475925 | 12147592 | 23 | 20141027 | 0 | ||
| 121475925 | 12147592 | 24 | 20141027 | 0 | ||
| 121475925 | 12147592 | 25 | 20141202 | 0 | ||
| 121475925 | 12147592 | 26 | 20141027 | 0 | ||
| 121475925 | 12147592 | 27 | 20141105 | 0 | ||
| 121475925 | 12147592 | 28 | 20150901 | 0 |