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 @ 5:37 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT03003468
Description: None
Frequency Threshold: 0
Time Frame: All-Cause Mortality was monitored up to a maximum of 52 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
Study: NCT03003468
Study Brief: Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Imprime PGG 2 mg/kg Phase Ib (Imprime PGG 2 mg/kg): Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. 3 None 1 3 3 3 View
Imprime PGG 4 mg/kg Phase Ib (Imprime PGG 4 mg/kg): Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Phase II (Imprime PGG 4 mg/kg): Imprime PGG will be dosed at the dose established as the MTD in Phase Ib (4mg/kg) on Day 1, 8, and 15 for Cycles 1-4, and on Day 1 only for Cycles 5-16 of the 21 day cycle. Pembrolizumab will be infused at 200 mg on Day 1 of the 21 day cycle. On day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab infusion. 21 None 9 30 29 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
COLITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
INFUSION RELATED REACTION NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
PERIPHERAL MOTOR NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
PLEURAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
RESPIRATORY FAILURE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
ALLERGIC RHINITIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
CHEST WALL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
CHRONIC KIDNEY DISEASE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
EDEMA LIMBS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
ESOPHAGEAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
EYE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
GINGIVAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
HYPERGLYCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
NEUTROPHIL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
NON-CARDIAC CHEST PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
ORAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
PNEUMONITIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
PROTEINURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
RECURRENT LARYNGEAL NERVE PALSY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
SINUS PAIN NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
ALLERGIC REACTION NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAEv4 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv4 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
BLOATING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
BLURRED VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4 View
BRONCHOSPASM NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
CONJUNCTIVITIS NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEv4 View
ESOPHAGITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
FLASHING LIGHTS NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4 View
GAIT DISTURBANCE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
GASTROESOPHAGEAL REFLUX DISEASE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
HEARING IMPAIRED NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEv4 View
HEMORRHOIDS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
HOT FLASHES NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
HYPERTHYROIDISM NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv4 View
HYPOMAGNESEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOTHYROIDISM NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv4 View
INFUSION RELATED REACTION NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
LUNG INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
LYMPHOCYTE COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
MALAISE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
MOVEMENTS INVOLUNTARY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
MUSCLE WEAKNESS LOWER LIMB NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
PAIN OF SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
PARESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
PELVIC PAIN NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv4 View
PERIPHERAL MOTOR NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
POSTNASAL DRIP NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
PRESYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
PRODUCTIVE COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
RASH ACNEIFORM NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv4 View
SINUSITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
SOMNOLENCE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
TUMOR PAIN NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAEv4 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
URTICARIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
VAGINAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
VOICE ALTERATION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
WEIGHT GAIN NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
FLU LIKE SYMPTOMS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
FLUSHING NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
HYPONATREMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
NASAL CONGESTION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
NECK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
OSTEONECROSIS OF JAW NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
SYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
THROMBOEMBOLIC EVENT NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
TREMOR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
SORE THROAT NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
ACUTE KIDNEY INJURY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View