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| Name | Class |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
Not provided
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The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously) |
|
| B | Active Comparator | dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival was defined as the time from the date of randomization to the date of death from any cause. | The final analysis was to be performed when at least 616 deaths had occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. | Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival. |
| Objective Response Rate in Subjects With Measurable Lesions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21600759 | Result | Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolomide | temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously) |
| FG001 | Dacarbazine | dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide | temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously) |
| BG001 | Dacarbazine | dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Progression Free Survival | Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. | Intent to Treat Population | Posted | Median | 95% Confidence Interval | Months | Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival. |
|
Not provided
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temozolomide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA HAEMOLYTIC AUTOIMMUNE | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
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Not provided
|
|
| Dacarbazine | Drug | intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop. |
|
|
Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter. |
| Treatment continued until disease progression or unacceptable toxicity. |
| Duration of Objective Response | Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented. | Treatment continued until disease progression or unacceptable toxicity. |
| Death not due to malignancy/toxicity |
|
| Medical Decision unrelated toxicity/PD |
|
| Other Reason |
|
| Ongoing (still on treatment) |
|
| Major Protocol Violation |
|
| Toxicity (Related AE) |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Overall Survival | Overall Survival was defined as the time from the date of randomization to the date of death from any cause. | Intent to Treat Population | Posted | Median | 95% Confidence Interval | Months | The final analysis was to be performed when at least 616 deaths had occurred. |
|
|
|
|
| Secondary | Objective Response Rate in Subjects With Measurable Lesions | Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter. | Intent to treat population with measurable disease at Baseline. | Posted | Median | 95% Confidence Interval | Ratio | Treatment continued until disease progression or unacceptable toxicity. |
|
|
|
|
| Secondary | Duration of Objective Response | Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented. | All responders | Posted | Median | 95% Confidence Interval | Months | Treatment continued until disease progression or unacceptable toxicity. |
|
|
|
| 124 |
| 419 |
| 394 |
| 419 |
| EG001 | Dacarbazine | 100 | 421 | 374 | 421 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| NORMOCHROMIC NORMOCYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| ARRHYTHMIA SUPRAVENTRICULAR | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| NODAL ARRHYTHMIA | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| GLAUCOMA | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| KERATITIS | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| PHOTOPHOBIA | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| UVEITIS | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| VITREOUS HAEMORRHAGE | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| COLONIC FISTULA | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| COLONIC OBSTRUCTION | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| INTRA-ABDOMINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| PERFORMANCE STATUS DECREASED | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| HEPATIC PAIN | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
|
| ABSCESS INTESTINAL | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| ENDOCARDITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| ERYSIPELAS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| HAEMOPHILUS INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| INFECTIVE MYOSITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| SALPINGITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| SERRATIA INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| SKIN INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| TOOTH ABSCESS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| AORTIC INJURY | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| BLOOD CALCIUM INCREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| BLOOD GLUCOSE DECREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| BLOOD POTASSIUM DECREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| MINI MENTAL STATUS EXAMINATION ABNORMAL | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| OSTEOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| SOFT TISSUE NECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| ATAXIA | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| COGNITIVE DISORDER | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| CONUS MEDULLARIS SYNDROME | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| CONVULSION | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| HEMIPLEGIA | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| NEURALGIA | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| NEUROLOGICAL SYMPTOM | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| SYNCOPE VASOVAGAL | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| DRUG DEPENDENCE | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| HAEMORRHAGE URINARY TRACT | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| PLEURAL FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| ABDOMINAL CAVITY DRAINAGE | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
|
| LYMPHADENECTOMY | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
|
| MALIGNANT TUMOUR EXCISION | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
|
| MASTECTOMY | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
|
| PLEURODESIS | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
|
| SKIN LESION EXCISION | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
|
| THORACIC CAVITY DRAINAGE | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
|
| HAEMATOMA | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |