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 @ 10:57 PM
Ignite Modification Date: 2025-12-25 @ 8:25 PM
NCT ID: NCT01674569
Description: Since the sample size for each dose group of X82 was limited, the frequency of adverse events are reported for all patients enrolled in the study.
Frequency Threshold: 5
Time Frame: Adverse events were recorded for the duration of the study beginning at participant randomization and continuing till participant completion of the study. The participation of individual subjects in the study ranged from 1-7 months.
Study: NCT01674569
Study Brief: Pilot Study of X-82 in Patients With Wet AMD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose Escalation of X-82 and Ranibizumab Rescue Groups of participants were assigned to 1 of 6 X-82 doses over 24 weeks,with an additional 4 weeks for follow-up. The dose escalated from one level to the next in the absence of any dose-limiting toxicity (DLT) defined as a drug-related safety event during the first 2 weeks of treatment that was severe enough to require removal of the participant from the study. The escalating X82 oral dose regimens were 50 mg alternate days, 50 mg daily, 100 mg alternate days, 100mg daily, 200mg daily, and 300mg daily. 0 None 3 35 28 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA 17.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA 17.1 View
Acute renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedRA 17.1 View
multiple myeloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA 17.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA 17.1 View
Gastrointestinal reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA 17.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA 17.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedRA 17.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedRA 17.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedRA 17.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedRA 17.1 View
Alanine amino transferase elevation NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedRA 17.1 View
Aspartate amino transferase elevation NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedRA 17.1 View
decrease body weight NON_SYSTEMATIC_ASSESSMENT General disorders MedRA 17.1 View
muscle spasma NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA 17.1 View
arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA 17.1 View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders MedRA 17.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders MedRA 17.1 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA 17.1 View
hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA 17.1 View