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: 2025-12-25 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:14 AM
NCT ID: NCT01273805
Description: Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
Frequency Threshold: 0
Time Frame: Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Study: NCT01273805
Study Brief: Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic 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
Hydroxychloroquine 400 mg b.i.d. Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision. 0 None 1 10 10 10 View
Hydroxychloroquine 600 mg b.i.d. Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision. 0 None 1 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
lymphopenia SYSTEMATIC_ASSESSMENT Investigations 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 (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Elevated alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Elevated alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Elevated aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Facial edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Rash, maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View