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 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 1:21 AM
NCT ID: NCT05483933
Description: Serious Treatment-Emergent Adverse Events by Preferred Term
Frequency Threshold: 5
Time Frame: Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Study: NCT05483933
Study Brief: Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mirvetuximab + SL-172154 3.0 mg/kg SL-172154 on Days 8 and 15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle 30 None 17 65 65 65 View
Pegylated Liposomal Doxorubicin + SL-172154 3.0 mg/kg SL-172154 on Days 8 an15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle 12 None 4 21 20 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Small Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchial secretion retention NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cytokine release syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Intestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Spinal cord infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vision Blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Keratopathy NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia 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
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurotoxicity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Small Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View