Adverse Events Module

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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 @ 12:25 PM
Ignite Modification Date: 2025-12-25 @ 12:04 PM
NCT ID: NCT01251861
Description: All-cause mortality was monitored in all randomized patients and all other adverse events were assessed in participants who received treatment.
Frequency Threshold: 5
Time Frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment (up to about 76 weeks)
Study: NCT01251861
Study Brief: Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate 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
Arm A (Observation + Bicalutamide) Patients undergo observation on weeks 1-12. Patients then receive bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of \>= 50% may continue on bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity. 9 None 1 50 39 50 View
Arm B (MK-2206 + Bicalutamide) Patients receive Akt inhibitor MK2206 PO once per week on weeks 1-44 and bicalutamide PO QD on weeks 13-44. Patients with a PSA decline of \>= 50% may continue on Akt inhibitor MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity. 9 None 33 53 52 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Blood and lymphatic disorders - Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Skin and subcutaneous tissue - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 4.0 View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 4.0 View
Reproductive system and breast - Other SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 4.0 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View