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 @ 1:32 AM
Ignite Modification Date: 2025-12-25 @ 11:45 PM
NCT ID: NCT00754494
Description: None
Frequency Threshold: 0
Time Frame: The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
Study: NCT00754494
Study Brief: Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma
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 I (25 mg) Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD. erlotinib hydrochloride: Given PO placebo: Given PO laboratory biomarker analysis: Correlative studies None None 1 15 12 15 View
Arm II (50 mg) Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD. erlotinib hydrochloride: Given PO placebo: Given PO laboratory biomarker analysis: Correlative studies None None 0 15 13 15 View
Arm III (100 mg) Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD. erlotinib hydrochloride: Given PO placebo: Given PO laboratory biomarker analysis: Correlative studies None None 0 15 13 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CHEST PAIN NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MILD INDIGESTION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
80% DIMINISHED SEBORRHEIC KERATOSIS SKIN LESIONS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ALLERGIC REACTION: RASH ON THE FACE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
BLOODY NOSE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
BLUE COLORED URINE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
BLUE/GREEN COLORED URINE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
BLURRING OF VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
CANKER SORES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
CLEARED UP ACNE ON MY FOREHEAD NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
COLD NON_SYSTEMATIC_ASSESSMENT General disorders None View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DEEP BRUISED LFT LEG PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHEA-FREQUENT BM'S NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DRY & ITCHY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DRY EYE NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
DRY EYES NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
DRY ITCHY EYE NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DRY SKIN AROUND NOSE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DRY SKIN ON NOSE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DRY SKIN-(LEGS) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DRYNESS OF EYES NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
DRYNESS OF SKIN ON FACE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DULL SORENESS IN LEG NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
EARACHE NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
FACE PIMPLES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
FACE SORE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders None View
FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FLU NON_SYSTEMATIC_ASSESSMENT General disorders None View
FOLLICULAR RASH ON TORSO NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HEARTBURN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INCARCERATED HERNIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
IRRITABLE-MOOD ALTERATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ITCHINESS OF EYES NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
LIGHT HEADED NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
LOOSE STOOLS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LOSS OF APPETITE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LOTS OF GAS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MILD DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MILD RASH IN THE BUTTOCK NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
MOUTH SORES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NOSE BLEED NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PAIN ON ABDOMEN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PAIN ON FOOT NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAINFUL ITCHY & TENDER SCALP NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON CHEST NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON FACE, CHEST AND SHOULDER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON FACE, CHEST, AND BEHIND EARS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON FACE, SCALP AND CHEST NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON FACE, SCALP, CHEST NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON FACE, SCALP, CHEST, BACK, EXTREMITIES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON FOOT NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON FOREHEAD/NOSE/CHEST NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RAW NOSE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RED ITCHY FACE RASH ON CHEEKS & NOSE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RED PUFFY EYES NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
RED RASH-FACE PEELING & NOW WHITE HEAD PIMPLES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RED RASH-FACE,NOSE, & CHEST NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RED RASH-FACE-NECK-CHEST & SCALP-ITCHY NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RED,BUMPY FACE & CHEST RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RUNNY NOSE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SEEING BLACK SPOTS AND FLASHING LIGHTS IN LEFT EYE NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
SHORT OF BREATH EASILY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SHORT OF BREATH-DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SHOULDER PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SORE THROAT NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SWOLLEN FACE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SWOLLEN LEFT KNEE NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ULCER ON MUCOUS MEMBRANE IN MOUTH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
VOMIT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View