Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT01832506
Description:
None
Frequency Threshold:
0
Time Frame:
Baseline Up to 30 days after last dose of study drug administration (55.1 weeks)
Study:
NCT01832506
Study Brief:
A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MSC2156119J 215 mg | Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity. | None | None | 0 | 3 | 2 | 3 | View |
| MSC2156119J 300 mg | Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity. | None | None | 3 | 3 | 3 | 3 | View |
| MSC2156119J 500 mg | Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity. | None | None | 1 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| ALTERED STATE OF CONSCIOUSNESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| VESSEL PUNCTURE SITE ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| ABDOMINAL DISCOMFORT | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| ASCITES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| DENTAL CARIES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| PROCTALGIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| HYPOALBUMINAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| HYPONATRAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| AMYLASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 17.1 | View |
| LIPASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 17.1 | View |
| BLOOD CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 17.1 | View |
| C-REACTIVE PROTEIN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 17.1 | View |
| CANCER PAIN | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | View |
| TUMOUR ASSOCIATED FEVER | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | View |
| DYSGEUSIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| HYPOAESTHESIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| NEUROPATHY PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.1 | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.1 | View |
| DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.1 | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| DERMATITIS ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| DRUG ERUPTION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| URTICARIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| IRON DEFICIENCY ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.1 | View |
| EYE MOVEMENT DISORDER | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 17.1 | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| SUBCUTANEOUS ABSCESS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| WOUND COMPLICATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| URINARY TRACT OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 17.1 | View |
| DEEP VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.1 | View |
| THROMBOPHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.1 | View |
| VARICOSE VEIN | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.1 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| OEDEMA PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |