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 @ 5:36 PM
Ignite Modification Date: 2025-12-25 @ 3:07 PM
NCT ID: NCT02331368
Description: None
Frequency Threshold: 0
Time Frame: All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any serious adverse event (SAE), or follow up to a serious adverse event that occurred from the time the consent was signed through 90 days following cessation of treatment, or the initiation of new anti-multiple myeloma therapy (excluding maintenance treatment as specified in this protocol), whichever was earlier, was recorded.
Study: NCT02331368
Study Brief: Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anti-PD-1 (MK-3475) Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses. 0 None 14 32 30 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood and Lymphatic Disorder, Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infections and infestations - Other NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neoplasms benign, malignant and unspecified NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, thoracic and mediastinal disorders - Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radiculitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest pain - cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Endocrine disorders - Other NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye disorders - Other NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders - Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoidal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neck edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Autoimmune disorder NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bladder infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infections and infestations - Other NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucosal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis externa NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Papulopustular rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cholesterol high NON_SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cystitis noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Postnasal drip NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bullous dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury, poisoning and procedural complications - Other NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Investigations - Other NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Movements involuntary NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Radiculitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinus pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Genital edema NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Reproductive system and breast disorders - Other NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Laryngeal inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin and subcutaneous tissue disorders - Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Surgical and medical procedures - Other NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View