Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Group A, Control Group
|
Group B, Low Dose VT-122
|
Group C, High Dose VT-122
|
Arm/Group Description |
Supportive care only
|
VT-122 (dose of etodolac: 400 mg/da...
|
VT-122 (dose of etodolac: 800 mg/da...
|
Arm/Group Description |
Supportive care only
|
VT-122 (dose of etodolac: 400 mg/day) + supportive care
|
VT-122 (dose of etodolac: 800 mg/day) + supportive care
|
|
|
Group A, Control Group
|
Group B, Low Dose VT-122
|
Group C, High Dose VT-122
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
--/--
|
|
--/--
|
|
|
|
Group A, Control Group
|
Group B, Low Dose VT-122
|
Group C, High Dose VT-122
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
0/12 (0.00%)
|
|
4/12 (33.33%)
|
|
3/13 (23.08%)
|
|
Blood and lymphatic system disorders |
|
|
|
Thrombocytopenia |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Anaemia |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
Cardiorespiratory Failure |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
General disorders |
|
|
|
Disease Progression |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Death |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Infections and infestations |
|
|
|
Gastroenteritis |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Lower Respiratory Tract Infection |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
Headache |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Pleural Effusion |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Acute Respiratory Distress |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Term from vocabulary, MedDRA (9.0)
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Group A, Control Group
|
Group B, Low Dose VT-122
|
Group C, High Dose VT-122
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
7/12 (58.33%)
|
|
9/12 (75.00%)
|
|
10/13 (76.92%)
|
|
Blood and lymphatic system disorders |
|
|
|
Eosinophilia |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Leukocytosis |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Leukopenia |
1/12 (8.33%)
|
1 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Neutropenia |
1/12 (8.33%)
|
1 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Thrombocytopenia |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
Bradycardia |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
2/13 (15.38%)
|
2 |
Sinus bradycardia |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Ear and labyrinth disorders |
|
|
|
Vertigo |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Gastrointestinal disorders |
|
|
|
Abdominal Pain |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
1/13 (7.69%)
|
1 |
Constipation |
2/12 (16.67%)
|
2 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Diarrhea |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Dyspepsia |
2/12 (16.67%)
|
2 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Dysphagia |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Gastritis |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Nausea |
2/12 (16.67%)
|
2 |
1/12 (8.33%)
|
1 |
1/13 (7.69%)
|
1 |
Vomiting |
1/12 (8.33%)
|
1 |
1/12 (8.33%)
|
1 |
1/13 (7.69%)
|
1 |
General disorders |
|
|
|
Asthenia |
2/12 (16.67%)
|
2 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Chest Pain |
1/12 (8.33%)
|
1 |
2/12 (16.67%)
|
2 |
0/13 (0.00%)
|
0 |
Crepitations |
1/12 (8.33%)
|
1 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Fatigue |
1/12 (8.33%)
|
1 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Malaise |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Edema Peripheral |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Pyrexia |
2/12 (16.67%)
|
2 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Infections and infestations |
|
|
|
Infection |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Nasopharyngitis |
1/12 (8.33%)
|
1 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
Tracheal Deviation |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Investigations |
|
|
|
Alanine Aminotransferase Increased (SGPT) |
0/12 (0.00%)
|
0 |
2/12 (16.67%)
|
2 |
0/13 (0.00%)
|
0 |
Aspartate Aminotransferase Increased (SGOT) |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Blood Alkaline Phosphatase Increased |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Blood Creatinine Increased |
1/12 (8.33%)
|
1 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Breath Sounds Abnormal |
1/12 (8.33%)
|
1 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Heart Rate Decreased |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Liver Palpable Subcostal |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Weight Decreased |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Metabolism and nutrition disorders |
|
|
|
Anorexia |
2/12 (16.67%)
|
2 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthropathy |
1/12 (8.33%)
|
1 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Back Pain |
1/12 (8.33%)
|
1 |
2/12 (16.67%)
|
2 |
2/13 (15.38%)
|
2 |
Muscle Atrophy |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Pain In Extremity |
1/12 (8.33%)
|
1 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
Dizziness |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
0/13 (0.00%)
|
0 |
Headache |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Renal and urinary disorders |
|
|
|
Hematuria |
2/12 (16.67%)
|
2 |
0/12 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Cough |
3/12 (25.00%)
|
3 |
2/12 (16.67%)
|
2 |
2/13 (15.38%)
|
2 |
Dyspnea |
0/12 (0.00%)
|
0 |
1/12 (8.33%)
|
1 |
4/13 (30.77%)
|
4 |
Pleural Effusion |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Vascular disorders |
|
|
|
Hypotension |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Pallor |
0/12 (0.00%)
|
0 |
0/12 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
Term from vocabulary, MedDRA (9.0)
|