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 @ 2:28 PM
Ignite Modification Date: 2025-12-25 @ 1:03 PM
NCT ID: NCT01557959
Description: 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Frequency Threshold: 5
Time Frame: None
Study: NCT01557959
Study Brief: Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV 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
Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy) Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity. None None 39 44 44 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Low WBC SYSTEMATIC_ASSESSMENT Investigations None View
low Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Low Hemoglobin SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion (non-malignant) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Low ANC SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Investigations None View
hypocalcemia SYSTEMATIC_ASSESSMENT Investigations None View
hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Investigations None View
serum glutamic pyruvic transaminase SYSTEMATIC_ASSESSMENT Investigations None View
hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
serum glutamic oxaloacetic transaminase SYSTEMATIC_ASSESSMENT Investigations None View
hyperkalemia SYSTEMATIC_ASSESSMENT Investigations None View
Ocular/Visual - Other SYSTEMATIC_ASSESSMENT Eye disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT General disorders None View
Fever without neutropenia SYSTEMATIC_ASSESSMENT General disorders None View
Urinary frequency/urgency SYSTEMATIC_ASSESSMENT General disorders None View
Edema: limb SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Confusion SYSTEMATIC_ASSESSMENT General disorders None View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acidosis SYSTEMATIC_ASSESSMENT Investigations None View
Rash: acne/acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Partial Thromboplastin Time SYSTEMATIC_ASSESSMENT Investigations None View
Pain: Joint SYSTEMATIC_ASSESSMENT General disorders None View
Arthritis (non-septic) SYSTEMATIC_ASSESSMENT General disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain: Bone SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Chest wall SYSTEMATIC_ASSESSMENT General disorders None View
Rash: dermatitis associated with radiation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
"Hemorrhage, GI: Duodenum" SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemorrhage Stomach SYSTEMATIC_ASSESSMENT Vascular disorders None View
"Hemorrhage, CNS" SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hearing: patients without baseline audiogram and not enrolled in a monitoring program SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Flu-like syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Muscle weakness SYSTEMATIC_ASSESSMENT General disorders None View
Nail changes SYSTEMATIC_ASSESSMENT General disorders None View
"Stricture/stenosis (including anastomotic), GI: Esophagus" SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Extremity-limb SYSTEMATIC_ASSESSMENT General disorders None View
Pain (unspecified) SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Pleura SYSTEMATIC_ASSESSMENT General disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
"Hemorrhage, GI: Rectum" SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
"Hemorrhage, pulmonary/upper respiratory: Respiratory tract NOS" SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection with unknown ANC: Blood SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope (fainting) SYSTEMATIC_ASSESSMENT General disorders None View
Vasovagal episode SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Urinary with low grade neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death not associated with CTCAE term: Disease progression NOS SYSTEMATIC_ASSESSMENT General disorders None View
Thrombosis/embolism (vascular access-related) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain: Tumor pain SYSTEMATIC_ASSESSMENT General disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva SYSTEMATIC_ASSESSMENT Infections and infestations None View
"Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided" SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain: External ear SYSTEMATIC_ASSESSMENT General disorders None View
Infection with high grade neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood Infection with high grade neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Low WBC SYSTEMATIC_ASSESSMENT Investigations None View
low Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Low Hemoglobin SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT General disorders None View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Proteinuria SYSTEMATIC_ASSESSMENT Investigations None View
Hair loss SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion (non-malignant) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary/Upper Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neuropathy: sensory SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neuropathy: motor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Low ANC SYSTEMATIC_ASSESSMENT Investigations None View
Pain (unspecified) SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Taste alteration SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Neurology SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dermatology/Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rigors/chills SYSTEMATIC_ASSESSMENT General disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Investigations None View
hypoglycemia SYSTEMATIC_ASSESSMENT Investigations None View
hypercalcemia SYSTEMATIC_ASSESSMENT Investigations None View
hypocalcemia SYSTEMATIC_ASSESSMENT Investigations None View
hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
Bicarbonate serum-low SYSTEMATIC_ASSESSMENT Investigations None View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Investigations None View
hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
serum glutamic pyruvic transaminase SYSTEMATIC_ASSESSMENT Investigations None View
hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain: Head/headache SYSTEMATIC_ASSESSMENT General disorders None View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
serum glutamic oxaloacetic transaminase SYSTEMATIC_ASSESSMENT Investigations None View
hyperkalemia SYSTEMATIC_ASSESSMENT Investigations None View
hypernatremia SYSTEMATIC_ASSESSMENT Investigations None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ocular/Visual - Other SYSTEMATIC_ASSESSMENT Eye disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT General disorders None View
Fever without neutropenia SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection - Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Auditory/Ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Edema: head and neck SYSTEMATIC_ASSESSMENT Vascular disorders None View
Edema: limb SYSTEMATIC_ASSESSMENT Vascular disorders None View
Edema: trunk/genital SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn/dyspepsia SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Confusion SYSTEMATIC_ASSESSMENT General disorders None View
Pruritus/itching SYSTEMATIC_ASSESSMENT General disorders None View
Mood alteration: Agitation SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT General disorders None View
Depression SYSTEMATIC_ASSESSMENT General disorders None View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain: Abdomen SYSTEMATIC_ASSESSMENT General disorders None View
Acidosis SYSTEMATIC_ASSESSMENT Investigations None View
Rash: acne/acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Partial Thromboplastin Time SYSTEMATIC_ASSESSMENT Investigations None View
Alkalosis SYSTEMATIC_ASSESSMENT Investigations None View
Pain: Joint SYSTEMATIC_ASSESSMENT General disorders None View
Arthritis (non-septic) SYSTEMATIC_ASSESSMENT General disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain: Back SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Bone SYSTEMATIC_ASSESSMENT General disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils: Bronchus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchospasm wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain: Chest/thorax SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Chest wall SYSTEMATIC_ASSESSMENT General disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hemorrhage respiratory SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neuropathy: cranial: CN VII Motor-face; Sensory-taste SYSTEMATIC_ASSESSMENT General disorders None View
Glomerular filtration rate SYSTEMATIC_ASSESSMENT Investigations None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
"Watery eye (epiphora, tearing)" SYSTEMATIC_ASSESSMENT Eye disorders None View
Rash: hand-foot skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Memory impairment SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhage GI: Oral cavity SYSTEMATIC_ASSESSMENT Vascular disorders None View
Muscle weakness SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Muscle SYSTEMATIC_ASSESSMENT General disorders None View
Nail changes SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Extremity-limb SYSTEMATIC_ASSESSMENT General disorders None View
Palpitations SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Throat/pharynx/larynx SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Pleura SYSTEMATIC_ASSESSMENT General disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash: dermatitis associated with radiation: Chemoradiation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils: Skin (cellulitis) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils: Vagina SYSTEMATIC_ASSESSMENT Infections and infestations None View
blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain: Buttock SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Tumor pain SYSTEMATIC_ASSESSMENT General disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils: Nose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mucositis/stomatitis Oral cavity SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemorrhage pulmonary/upper respiratory SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva SYSTEMATIC_ASSESSMENT Infections and infestations None View
"Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower" SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neuropathy: cranial: CN VIII Hearing and balance SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View