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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT04589832
Description: None
Frequency Threshold: 0
Time Frame: All-Cause Mortality was monitored up to a maximum of 15 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to a maximum of 10 months.
Study: NCT04589832
Study Brief: Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Treatment Arm Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes. PAC-1: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle. Entrectinib: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle. 1 None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
URTICARIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
AKATHISIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ATAXIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
CHOLESTEROL HIGH NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
DYSARTHRIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
DYSGEUSIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
EDEMA FACE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
EDEMA LIMBS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
GAIT DISTURBANCE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
ENDOCRINE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv5 View
ERECTILE DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv5 View
EUPHORIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
EYE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
FALL NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEv5 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
FLASHING LIGHTS NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
FLOATERS NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
HYPERGLYCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
HYPERURICEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
HYPOTHYROIDISM NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv5 View
MEMORY IMPAIRMENT NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
NEUTROPHIL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
PAIN OF SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
PERIPHERAL SENSORY NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
PRESYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
RENAL AND URINARY DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
SLEEP APNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
TINNITUS NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEv5 View
URINARY INCONTINENCE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
URTICARIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
WEIGHT GAIN NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
WHITE BLOOD CELL DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View