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This clinical study was planned in order to assess the superiority of INNOCELL Corp. "Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Temozolomide to glioblastoma patients when compared with the control group who did not receive administration of the drug.
<Primary Purpose> Compare clinical efficacy of group treated with cell theraputic INNOCELL Immuncell-LC evaluated by progression free survival with that of untreated group.
<Secondary Purpose> Compare clinical efficacy of group treated with INNOCELL Immuncell-LC, a drug for treating glioblastoma evaluated by overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS) and that of untreated group, and evaluate adverse reactions, clinical pathological tests, and its safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks. | |
| Test Group | Experimental | The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated T lymphocyte(Immuncell-LC) | Drug | Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival(PFS) | Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3~12 months thereafter during the follow-up phase. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months. |
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Inclusion Criteria:
Patients who, prior to the study, received explanation of the purpose and content of study and of characteristics of the test drug from the test administrator and have consented to the study by providing signature of self, guardian, or legal representative.
Patients who are between 18 and 70 years of age
Patients whose cause of cancer has been found to be glioblastoma via pathological testing
patients who have received surgery for glioblastoma (Complete or partial extirpation or biopsy) 2 weeks prior to the study
Patients whose survival is expected to be longer than 3 months
Patients whose KPS is greater than 60
Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunghyun Kim, MD | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Guri Hospital | Guri-si | Gyeonggi-do | South Korea | |||
| Gyunghee University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks. |
| FG001 | CIK Immunotherapy Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Seoul |
| South Korea |
| Konkuk University | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Samsung Seoul Medical Center | Seoul | South Korea |
| Seoul Asan Medical Center | Seoul | South Korea |
| Yeonsei University Medical Center | Seoul | South Korea |
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times). Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
From December 2008 to October 2012, a total of 188 patients were screened from 7 institutes in Korea, 8 patients failed in the screening process, and 180 patients were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks. |
| BG001 | CIK Immunotherapy Group | The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times). Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Karnofsky performance scale | The Karnofsky Performance Scale (KPS) measures a patient's functional status and ability to carry out daily activities. Scores range from 0 to 100, where:
| Median | Full Range | units on a scale |
| ||||||||||||||
| Global health status/Quality of life | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) - a validated, cancer-specific instrument designed to assess the quality of life of cancer patients. The Global Health Status/Quality of Life (QoL) scale is one of the multi-item scales included in the instrument. The Global Health Status/QoL scale is scored from 0 to 100. Scores are transformed linearly following the EORTC scoring manual. Higher scores represent better health status and quality of life. Lower scores indicate poorer poorer perceived health and quality of life. | Median | Full Range | units on a scale |
| ||||||||||||||
| Tumor size | Median | Full Range | centimeter |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival(PFS) | Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3~12 months thereafter during the follow-up phase. | Posted | Median | 95% Confidence Interval | months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival(OS) | Posted | Median | 95% Confidence Interval | months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months. |
|
|
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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 | Control Group | The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks. | 52 | 89 | 31 | 89 | 83 | 89 |
| EG001 | Test Group | The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times). Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions) | 51 | 91 | 35 | 91 | 84 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Brain edema | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hydrocephalus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Non-systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| paraparesis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Partial seizure | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| cerebral cyst | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| cerebral infarction | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| cerebrovascular accident | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| dysarthria | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| monoparesis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| myoclonus | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| somnolence | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| speech disorder | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| pneumonia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| septic shock | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| appendicitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| bacteriaemia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| enterits infectious | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| lung abscess | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| meningitis aseptic | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| pulmonary tuberculosis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| pyrexia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| asthenia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| chills | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| general physical health deterioration | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| multi-organ failure | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| concussion | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| femur fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| hip fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| rib fracure | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| subdural hemorrhage | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| leukopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| diverticulum intestinal | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| large intestine perforation | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| pneumothroax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| alanine aminotransferase increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| neutrophil count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| platelet count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| white blood cell count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| hepatic steatosis | Hepatobiliary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| hepatitis acute | Hepatobiliary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| neurogenic bladder | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| swelling face | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| depression | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Abdominal Pain lower | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Faecal Incontinence | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Diverticulum itestinal | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dyschezia | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Mouth hemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Perianal erythema | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Eczema multiforme | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| intertrigo | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| dysarthria | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Partial Seizures | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cereral cyst | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Complex regional pain syndrome | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Facial spasm | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Head titubation | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neurologic neglect syndrome | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Quadriplegia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Stupor | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Vascular dementia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Deydration | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Diabetes melitus | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Fluid imbalance | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Oral candidasis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Bateraemia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Helicobacter Gastritis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Meningitis asceptic | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| PEritonitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Sinsitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Stitch abscess | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Tonsllitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| oedema | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Gait deviation | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Skin test positive | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Electocardiogram T wave abnormal | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Slep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Eye oedema | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Glare | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Visual activity reduced | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Mood disorder due to a general medical condition | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Personality disorder | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Micturition disorder | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Nurogenic bladder | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Bladder dilatation | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Enurresis | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Rnal tubular necrosis | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ear abrasion | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Joint disclocation | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| shock | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| otorrhoea | Ear and labyrinth disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Auricular swelling | Ear and labyrinth disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Calculus prostatic | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Galactorrhoea | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Genital discharge | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Vulvovaginal swelling | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ventricular dysfunction | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cushing's syndrome | Endocrine disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Non-systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CRA of Clinical Trial | GREEN CROSS CELL | 82-2-2101-0665 | 665 | a1pole@greencrosscell.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| Male |
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| Participants |
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