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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124200288 | 12420028 | 8 | F | 20140910 | 20160908 | 20160531 | 20160927 | EXP | JP-GLAXOSMITHKLINE-JP2014055223 | GLAXOSMITHKLINE | 42.00 | YR | M | Y | 0.00000 | 20160927 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124200288 | 12420028 | 1 | PS | VOLTAREN | DICLOFENAC SODIUM | 1 | Oral | 25 MG, QD | 22122 | 25 | MG | TABLET | QD | ||||||
| 124200288 | 12420028 | 2 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | Oral | 25 MG, BID | 22122 | 25 | MG | TABLET | BID | ||||||
| 124200288 | 12420028 | 3 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | Oral | UNK | 22122 | TABLET | |||||||||
| 124200288 | 12420028 | 4 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | 22122 | TABLET | |||||||||||
| 124200288 | 12420028 | 5 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | 450 UG, QD | 0 | 450 | UG | INHALATION POWDER | QD | ||||||
| 124200288 | 12420028 | 6 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | 150 UG, QD | 0 | 150 | UG | INHALATION POWDER | QD | ||||||
| 124200288 | 12420028 | 7 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 8 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 9 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 10 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 11 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 12 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 13 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 14 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 15 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 16 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 17 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 18 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK OT, BID | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 19 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | 150 UG, TID | 0 | 150 | UG | INHALATION POWDER | TID | ||||||
| 124200288 | 12420028 | 20 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK, BID | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 21 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | 150 UG, QD | 0 | 150 | UG | INHALATION POWDER | QD | ||||||
| 124200288 | 12420028 | 22 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK UNK, BID | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 23 | I | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | UNK UNK, BID | 0 | INHALATION POWDER | |||||||||
| 124200288 | 12420028 | 24 | I | ALCOHOL. | ALCOHOL | 1 | Oral | UNK | U | 0 | |||||||||
| 124200288 | 12420028 | 25 | C | MUCOSOLVAN (AMBROXOL HYDROCHLORIDE) | AMBROXOL HYDROCHLORIDE | 1 | Oral | UNK | U | 0 | |||||||||
| 124200288 | 12420028 | 26 | C | TENOMILOL | ATENOLOL | 1 | Oral | UNK | U | 0 | |||||||||
| 124200288 | 12420028 | 27 | C | NIFEDIPINE. | NIFEDIPINE | 1 | Oral | UNK | U | 0 | |||||||||
| 124200288 | 12420028 | 28 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | TABLET | QD | |||||
| 124200288 | 12420028 | 29 | C | ZYLORIC | ALLOPURINOL | 1 | Oral | UNK | U | 0 | |||||||||
| 124200288 | 12420028 | 30 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 124200288 | 12420028 | 31 | C | HYPEN | ETODOLAC | 1 | Unknown | UNK | U | 0 | |||||||||
| 124200288 | 12420028 | 32 | C | SENNOSIDE A+B | SENNOSIDES A AND B | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124200288 | 12420028 | 1 | Headache |
| 124200288 | 12420028 | 2 | Pain in extremity |
| 124200288 | 12420028 | 3 | Back pain |
| 124200288 | 12420028 | 4 | Proctalgia |
| 124200288 | 12420028 | 5 | Emphysema |
| 124200288 | 12420028 | 6 | Chronic obstructive pulmonary disease |
| 124200288 | 12420028 | 24 | Product used for unknown indication |
| 124200288 | 12420028 | 25 | Productive cough |
| 124200288 | 12420028 | 26 | Product used for unknown indication |
| 124200288 | 12420028 | 27 | Product used for unknown indication |
| 124200288 | 12420028 | 28 | Product used for unknown indication |
| 124200288 | 12420028 | 29 | Product used for unknown indication |
| 124200288 | 12420028 | 30 | Angina pectoris |
| 124200288 | 12420028 | 31 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124200288 | 12420028 | HO |
| 124200288 | 12420028 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124200288 | 12420028 | Abdominal pain | |
| 124200288 | 12420028 | Abdominal pain upper | |
| 124200288 | 12420028 | Alanine aminotransferase increased | |
| 124200288 | 12420028 | Alcohol abuse | |
| 124200288 | 12420028 | Alcohol interaction | |
| 124200288 | 12420028 | Alopecia | |
| 124200288 | 12420028 | Altered state of consciousness | |
| 124200288 | 12420028 | Angina pectoris | |
| 124200288 | 12420028 | Anxiety | |
| 124200288 | 12420028 | Arthralgia | |
| 124200288 | 12420028 | Arthropathy | |
| 124200288 | 12420028 | Aspiration | |
| 124200288 | 12420028 | Asthenia | |
| 124200288 | 12420028 | Asthma | |
| 124200288 | 12420028 | Back pain | |
| 124200288 | 12420028 | Blood glucose increased | |
| 124200288 | 12420028 | Blood pressure increased | |
| 124200288 | 12420028 | Blood sodium decreased | |
| 124200288 | 12420028 | Blood urea decreased | |
| 124200288 | 12420028 | Cardiac disorder | |
| 124200288 | 12420028 | Cerebrovascular disorder | |
| 124200288 | 12420028 | Chest pain | |
| 124200288 | 12420028 | Chills | |
| 124200288 | 12420028 | Chromaturia | |
| 124200288 | 12420028 | Chronic obstructive pulmonary disease | |
| 124200288 | 12420028 | Constipation | |
| 124200288 | 12420028 | Cough | |
| 124200288 | 12420028 | Deafness | |
| 124200288 | 12420028 | Decreased appetite | |
| 124200288 | 12420028 | Diarrhoea | |
| 124200288 | 12420028 | Dizziness | |
| 124200288 | 12420028 | Drug ineffective | |
| 124200288 | 12420028 | Dry mouth | |
| 124200288 | 12420028 | Dry throat | |
| 124200288 | 12420028 | Duodenitis | |
| 124200288 | 12420028 | Dysarthria | |
| 124200288 | 12420028 | Dysphonia | |
| 124200288 | 12420028 | Dyspnoea | |
| 124200288 | 12420028 | Electrolyte imbalance | |
| 124200288 | 12420028 | Fall | |
| 124200288 | 12420028 | Feeling abnormal | |
| 124200288 | 12420028 | Flatulence | |
| 124200288 | 12420028 | Gait disturbance | |
| 124200288 | 12420028 | Gamma-glutamyltransferase increased | |
| 124200288 | 12420028 | General physical health deterioration | |
| 124200288 | 12420028 | Gingival pain | |
| 124200288 | 12420028 | Hair colour changes | |
| 124200288 | 12420028 | Head injury | |
| 124200288 | 12420028 | Headache | |
| 124200288 | 12420028 | Hepatic steatosis | |
| 124200288 | 12420028 | Hunger | |
| 124200288 | 12420028 | Hypoaesthesia | |
| 124200288 | 12420028 | Inappropriate schedule of drug administration | |
| 124200288 | 12420028 | Incontinence | |
| 124200288 | 12420028 | Increased appetite | |
| 124200288 | 12420028 | Insomnia | |
| 124200288 | 12420028 | Intercostal neuralgia | |
| 124200288 | 12420028 | Irritability | |
| 124200288 | 12420028 | Joint stiffness | |
| 124200288 | 12420028 | Laryngeal discomfort | |
| 124200288 | 12420028 | Lymphocyte percentage decreased | |
| 124200288 | 12420028 | Malignant melanoma | |
| 124200288 | 12420028 | Migraine | |
| 124200288 | 12420028 | Miliaria | |
| 124200288 | 12420028 | Muscle spasms | |
| 124200288 | 12420028 | Muscle twitching | |
| 124200288 | 12420028 | Musculoskeletal pain | |
| 124200288 | 12420028 | Myalgia | |
| 124200288 | 12420028 | Nail discolouration | |
| 124200288 | 12420028 | Nasal congestion | |
| 124200288 | 12420028 | Nasopharyngitis | |
| 124200288 | 12420028 | Nausea | |
| 124200288 | 12420028 | Neck pain | |
| 124200288 | 12420028 | Nocturnal dyspnoea | |
| 124200288 | 12420028 | Oropharyngeal pain | |
| 124200288 | 12420028 | Overdose | |
| 124200288 | 12420028 | Pain | |
| 124200288 | 12420028 | Pain in extremity | |
| 124200288 | 12420028 | Painful respiration | |
| 124200288 | 12420028 | Palpitations | |
| 124200288 | 12420028 | Paralysis | |
| 124200288 | 12420028 | Personality disorder | |
| 124200288 | 12420028 | Pharyngeal disorder | |
| 124200288 | 12420028 | Pharyngeal erythema | |
| 124200288 | 12420028 | Platelet count decreased | |
| 124200288 | 12420028 | Pneumonia aspiration | |
| 124200288 | 12420028 | Poor quality sleep | |
| 124200288 | 12420028 | Productive cough | |
| 124200288 | 12420028 | Pruritus genital | |
| 124200288 | 12420028 | Pulmonary pain | |
| 124200288 | 12420028 | Renal disorder | |
| 124200288 | 12420028 | Respiratory rate increased | |
| 124200288 | 12420028 | Rhabdomyolysis | |
| 124200288 | 12420028 | Rhinorrhoea | |
| 124200288 | 12420028 | Skin discolouration | |
| 124200288 | 12420028 | Sleep disorder | |
| 124200288 | 12420028 | Spinal pain | |
| 124200288 | 12420028 | Sputum discoloured | |
| 124200288 | 12420028 | Sputum increased | |
| 124200288 | 12420028 | Thinking abnormal | |
| 124200288 | 12420028 | Thirst | |
| 124200288 | 12420028 | Throat irritation | |
| 124200288 | 12420028 | Thyroid pain | |
| 124200288 | 12420028 | Tinnitus | |
| 124200288 | 12420028 | Tremor | |
| 124200288 | 12420028 | Urine odour abnormal | |
| 124200288 | 12420028 | Weight decreased | |
| 124200288 | 12420028 | Weight increased | |
| 124200288 | 12420028 | White blood cell count increased | |
| 124200288 | 12420028 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 124200288 | 12420028 | 3 | 20150622 | 0 | ||
| 124200288 | 12420028 | 5 | 201402 | 0 | ||
| 124200288 | 12420028 | 7 | 20140918 | 0 | ||
| 124200288 | 12420028 | 8 | 20141021 | 0 | ||
| 124200288 | 12420028 | 9 | 20141022 | 0 | ||
| 124200288 | 12420028 | 10 | 20141105 | 0 | ||
| 124200288 | 12420028 | 11 | 20150126 | 0 | ||
| 124200288 | 12420028 | 12 | 20150127 | 0 | ||
| 124200288 | 12420028 | 13 | 20150209 | 0 | ||
| 124200288 | 12420028 | 14 | 20150218 | 0 | ||
| 124200288 | 12420028 | 15 | 20150313 | 0 | ||
| 124200288 | 12420028 | 16 | 20150316 | 0 | ||
| 124200288 | 12420028 | 17 | 20150319 | 0 | ||
| 124200288 | 12420028 | 18 | 20150510 | 0 | ||
| 124200288 | 12420028 | 19 | 20150511 | 0 | ||
| 124200288 | 12420028 | 20 | 20150518 | 0 |