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 @ 4:13 AM
Ignite Modification Date: 2025-12-26 @ 3:12 AM
NCT ID: NCT03713320
Description: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Frequency Threshold: 5
Time Frame: All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months
Study: NCT03713320
Study Brief: SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cobomarsen (Randomized) Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion 0 None 2 19 18 19 View
Vorinostat (Randomized) Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules 0 None 1 18 18 18 View
Cobomarsen (Crossover) For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion 0 None 0 7 5 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Superinfection of Skin Lesions SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Crystal urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Deafness unilateral SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastoenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Overgrowth bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pain in extermity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Palmar erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Parosmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Seborrhoeic keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Skin bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin plaque SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin weeping SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Superinfection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Superinfection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Tumour flare SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Tumour inflammation SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urine abnormality SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Urine albumin/creatinine ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
White blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Bacterial test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood alkaline phosphatase increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View