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 @ 11:24 PM

Ignite Modification Date: 2025-12-25 @ 9:10 PM

NCT ID: NCT02129556

Description: Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.

Frequency Threshold: 0

Time Frame: From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.

Study: NCT02129556

Study Brief: Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast 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

Phase Ib	HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. All 6 patients in Phase I were combined when reporting clinical measures for secondary outcomes adverse events for stronger response rates.	4	None	4	6	6	6	View
Phase II (PD-L1+ and PD-L1-)	HER2-positive, PD-L1 expressing or PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. For adverse events, Phase II cohorts were combined since PD-L1 status does not affect toxicity.	25	None	25	52	50	52	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Gastroenteritis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Takotsubo cardiomyopathy	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Shoulder pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
CNS metastases	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Vertigo	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Disease progression	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Death	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Upper respiratory infection	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Breast infection	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Bile duct dilatation	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Catheter-related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Plural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Intracranial hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Cognitive disturbance	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Acute renal impairment	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Retinal vein occlusion	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Pericardial effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Hepatic hemorrhage	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Lambert-Eaton syndrome	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
GGT increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Paresthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Neurological paresis	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Aphasia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Glioblastoma multiforme	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Drug-induced liver injury	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Autoimmune hepatitis	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Pulmonary embolism	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Sore throat	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Fever	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Lymph node pain	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Reactive thrombocytosis	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Pericardial effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinus tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Takotsubo cardiomyopathy	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Hearing impaired	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Vertigo	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Hyperthyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Hypothyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Dry eye	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Retinal vascular disorder	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Visual field defect left lower quadrants	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain, intermittent	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dry mouth	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastritis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastroenteritis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastroesophageal reflux disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Mucositis oral	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea with weight loss	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Tongue mycosis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Anemia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Diaphoresis	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Edema limbs	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Edema trunk	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fever	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Flu-like symptoms	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hoarseness	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Infusion related reaction	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Left breast tumour bleeding	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Localized edema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Malaise	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Non-cardiac chest pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Bile duct dilatation	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Autoimmune disorder	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Bronchial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Catheter-related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Dental	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Esophageal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Laryngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pharyngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Rhinitis infective	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Upper respiratory infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Yeasts in the stool	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Drug induced liver injury	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Ggt increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypercalcemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Leucocyte count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lipase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lymphocyte count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Serum amylase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight loss	SYSTEMATIC_ASSESSMENT	Investigations	None	View
White blood cell decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Anorexia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypercalcemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperglycemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperkalemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperuricemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoalbuminemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypocalcemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Bone pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Buttock pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Shoulder pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Stiffness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Aphasia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Aphonia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Ataxia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Balance disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Cognitive disturbance	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysgeusia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysphasia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Loss of hand motor traction	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Memory impairment	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Paresthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Static cerebellar syndrom	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Tremor	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Vasovagal reaction	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Acute renal impairment	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Chronic kidney disease	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
UTI	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Breast pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Bronchopulmonary hemorrhage	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis: seasonal	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Laryngeal inflammation	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Productive cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory distress	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Shortness of breath	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Sinus disorder	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Viral upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Cutaneous rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Cutaneous toxicity on legs and arms	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dry skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Erysipelas	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Hyperhidrosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Palmar-plantar erythrodysesthesia syndrome	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Photosensitivity	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash - face	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash acneiform	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash maculo-papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Redness ankle and feet	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Shingles	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Hot flashes	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Intracranial hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Lymphedema	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Lymphedema right leg	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Thromboembolic event	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View