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: 2025-12-25 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT03554005
Description: All enrolled participants
Frequency Threshold: 5
Time Frame: Up to 42 weeks
Study: NCT03554005
Study Brief: Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PEG Interferon Alfa-2b 0.75 mcg/kg OW Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. 0 None 0 1 1 1 View
PEG Interferon Alfa-2b 1.5 mcg/kg OW Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. 0 None 1 2 2 2 View
PEG Interferon Alfa-2b 7.5 mcg/kg OW Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. 0 None 3 11 11 11 View
PEG Interferon Alfa-2b 3 mcg/kg OW Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. 0 None 0 2 1 2 View
PEG Interferon Alfa-2b 4.5 mcg/kg OW Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. 0 None 0 2 2 2 View
PEG Interferon Alfa-2b 6 mcg/kg OW Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. 1 None 1 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
JOINT SWELLING SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
EYE IRRITATION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
VISUAL ACUITY REDUCED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ASCITES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GINGIVAL BLEEDING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
HAEMATOCHEZIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
STOMACH DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INJECTION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INJECTION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INJECTION SITE PRURITUS SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INJECTION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INJECTION SITE WARMTH SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
RESPIRATORY SIGHS SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ORAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
STREPTOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
TOOTH ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
INCISION SITE PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
THERMAL BURN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
APPETITE DISORDER SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
INCREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
LOWER EXTREMITY MASS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
MYALGIA INTERCOSTAL SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
DISTURBANCE IN ATTENTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
MEMORY IMPAIRMENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
MENTAL IMPAIRMENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SENSORY DISTURBANCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
APATHY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
FOOD AVERSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
LIBIDO DECREASED SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
SOCIAL PHOBIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
GENITAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
INCREASED UPPER AIRWAY SECRETION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
ACNE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
EXFOLIATIVE RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
HAIR COLOUR CHANGES SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
PHOTOSENSITIVITY REACTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
RASH MACULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
SCAR PAIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
SKIN REACTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
VITILIGO SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
SENSATION OF HEAVINESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
APHASIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
BURNING SENSATION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
NEURALGIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
CIRCULATORY COLLAPSE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View