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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
NCT ID:
NCT02227667
Description:
None
Frequency Threshold:
5
Time Frame:
2 years
Study:
NCT02227667
Study Brief:
Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Patients With Advanced Colorectal Cancer | This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments. MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit. | 7 | None | 8 | 16 | 16 | 16 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nervous system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |