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 @ 7:45 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT00216203
Description: Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
Frequency Threshold: 0
Time Frame: Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Study: NCT00216203
Study Brief: Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung 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
Pemetrexed + Cetuximab Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer. Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles Cetuximab: Cetuximab 400 mg/m2, week 1, day 1 Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle None None 11 36 32 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CNS CEREBROVASCULAR ISCHEMIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
DEATH NOT ASSOCIATED WITH CTCAE TERM / DISEASE PROGRESSION NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
DYSPNEA (SHORTNESS OF BREATH) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / LUNG NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
INFECTION - OTHER (SPECIFY, __) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BONE (OSTEOMYELITIS) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
PNEUMONITIS/PULMONARY INFILTRATES NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
PTT (PARTIAL THROMBOPLASTIN TIME) NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAEv3 View
RASH: ACNE/ACNEIFORM NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
AUDITORY/EAR - OTHER NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEv3 View
BILIRUBIN (HYPERBILIRUBINEMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
BRONCHOSPASM, WHEEZING NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
CALCIUM, SERUM-LOW (HYPOCALCEMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
COAGULATION - OTHER NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
CONFUSION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
CONSTITUTIONAL SYMPTOMS - OTHER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
DERMATOLOGY/SKIN - OTHER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
DYSPNEA (SHORTNESS OF BREATH) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
EDEMA: HEAD AND NECK NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
EDEMA: LIMB NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
EYELID DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv3 View
FATIGUE (ASTHENIA, LETHARGY, MALAISE) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
GASTROINTESTINAL - OTHER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
HAIR LOSS/ALOPECIA (SCALP OR BODY) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
HEARTBURN/DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
HEMOGLOBIN NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
HEMORRHAGE, GI / ANUS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / LUNG NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
HEMORRHAGE/BLEEDING - OTHER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
HEMORRHOIDS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
HYPOXIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / UNGUAL (NAILS) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
INFECTION - OTHER NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / CONJUNCTIVA NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / MUCOSA NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
LEUKOCYTES (TOTAL WBC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
METABOLIC/LABORATORY - OTHER NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
MOOD ALTERATION / AGITATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv3 View
MOOD ALTERATION / ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv3 View
MOOD ALTERATION / DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv3 View
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAEv3 View
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / PHARYNX NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAEv3 View
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv3 View
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv3 View
NAIL CHANGES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
NEUROPATHY: CRANIAL / CN VIII HEARING AND BALANCE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
NEUROPATHY: SENSORY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
NEUTROPHILS/GRANULOCYTES (ANC/AGC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
OBSTRUCTION/STENOSIS OF AIRWAY / BRONCHUS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
OTITIS, EXTERNAL EAR (NON-INFECTIOUS) NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEv3 View
PAIN / ABDOMEN NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
PAIN / BACK NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
PAIN / BONE NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv3 View
PAIN / CHEST WALL NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
PAIN / CHEST/THORAX NOS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
PAIN / FACE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
PAIN / HEAD/HEADACHE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
PAIN / JOINT NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv3 View
PAIN / MUSCLE NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv3 View
PAIN / PLEURA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
PAIN / TUMOR PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
PAIN / URETHRA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv3 View
PAIN - OTHER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
PERICARDIAL EFFUSION (NON-MALIGNANT) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv3 View
PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS) NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv3 View
PLATELETS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
PNEUMONITIS/PULMONARY INFILTRATES NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
POTASSIUM, SERUM-LOW (HYPOKALEMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
PROCTITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
PRURITUS/ITCHING NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
PULMONARY/UPPER RESPIRATORY - OTHER NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
RASH/DESQUAMATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
RASH: ACNE/ACNEIFORM NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
RASH: HAND-FOOT SKIN REACTION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
RIGORS/CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
SKIN BREAKDOWN/DECUBITUS ULCER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
SODIUM, SERUM-LOW (HYPONATREMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv3 View
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv3 View
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv3 View
SWEATING (DIAPHORESIS) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
TASTE ALTERATION (DYSGEUSIA) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
TREMOR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
URINARY FREQUENCY/URGENCY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv3 View
URTICARIA (HIVES, WELTS, WHEALS) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
WEIGHT LOSS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View