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:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-25 @ 12:45 PM
NCT ID:
NCT02420795
Description:
None
Frequency Threshold:
1
Time Frame:
From the first dose through every 3 months after the last dose of study medication, up to 1 year.
Study:
NCT02420795
Study Brief:
Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ONC201 125 mg | Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 0 | None | 0 | 4 | 4 | 4 | View |
| ONC201 250 mg | Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 0 | None | 1 | 2 | 2 | 2 | View |
| ONC201 625 mg | Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 1 | None | 1 | 5 | 5 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.3) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Blood and lymphatic system disorders- Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12) | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.3) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12) | View |
| Appetite change | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12) | View |
| AST increased | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Blood and lymphatic system disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12) | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12) | View |
| Bug bites | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| BUN increased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12) | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (12) | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Edema trunk | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Elevated LDH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| GI bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (12) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12) | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (12) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.3) | View |
| Memory changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12) | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12) | View |
| Peripheral Sensory Neuoropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12) | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12) | View |
| Redness (both ears) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12) | View |
| Renal insufficiency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12) | View |
| Right carotid artery disease | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Runny nose | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Seasonal allergies | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12) | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12) | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12) | View |
| Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12) | View |
| Alkaline phosphatase increased (ALT) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Left hip and thigh pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Left lower back pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Left lower leg pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Left quadrant abdominal pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Left shoulder pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Legs Muscle Cramps | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Loss of hearing on right ear | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (12) | View |
| Numbness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12) | View |
| Oral Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12) | View |
| Right Hip Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Right Upper Quadrant Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12) | View |
| Numbness/Tingling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12) | View |
| Platelet Count Decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12) | View |
| Acute abdominal pain on lower right | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12) | View |
| Chronic kidney disease (creatinine increased) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12) | View |
| Ecchymosis (bilateral forearms) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12) | View |
| Left ankle | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12) | View |
| Sleep disturbance | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12) | View |