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 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT03894618
Description: None
Frequency Threshold: 5
Time Frame: Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
Study: NCT03894618
Study Brief: SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SL-279252 (0.01 mg/kg S1) 0.01 mg/kg of IV SL-279252 (Schedule 1) 1 None 0 1 1 1 View
SL-279252 (1.0 mg/kg S2) 1.0 mg/kg of IV SL-279252 (Schedule 2) 5 None 2 6 5 6 View
SL-279252 (0.0001 mg/kg S1) 0.0001 mg/kg of IV SL-279252 (Schedule 1) 1 None 0 1 1 1 View
SL-279252 (0.001 mg/kg S1) 0.001 mg/kg of IV SL-279252 (Schedule 1) 1 None 1 1 1 1 View
SL-279252 (0.003 mg/kg S1) 0.003 mg/kg of IV SL-279252 (Schedule 1) 2 None 0 2 2 2 View
SL-279252 (0.03 mg/kg S1) 0.03 mg/kg of IV SL-279252 (Schedule 1) 0 None 0 2 2 2 View
SL-279252 (0.1 mg/kg S1) 0.1 mg/kg of IV SL-279252 (Schedule 1) 3 None 1 3 3 3 View
SL-279252 (0.3 mg/kg S1) 0.3 mg/kg of IV SL-279252 (Schedule 1) 4 None 1 4 4 4 View
SL-279252 (1.0 mg/kg S1) 1.0 mg/kg of IV SL-279252 (Schedule 1) 4 None 3 6 4 6 View
SL-279252 (3.0 mg/kg S1) 3.0 mg/kg of IV SL-279252 (Schedule 1) 5 None 1 6 6 6 View
SL-279252 (6.0 mg/kg S1) 6.0 mg/kg of IV SL-279252 (Schedule 1) 4 None 1 4 3 4 View
SL-279252 (12.0 mg/kg S1) 12.0 mg/kg of IV SL-279252 (Schedule 1) 2 None 0 4 4 4 View
SL-279252 (24.0 mg/kg S1) 24.0 mg/kg of IV SL-279252 (Schedule 1) 0 None 1 2 2 2 View
SL-279252 (0.3 mg/kg S2) 0.3 mg/kg of IV SL-279252 (Schedule 2) 2 None 0 4 4 4 View
SL-279252 (3.0 mg/kg S2) 3.0 mg/kg of IV SL-279252 (Schedule 2) 3 None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
infected neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
inguinal hernia, obstructive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
mouth haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
subarachnoid haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
acetabulum fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
diffuse large B-cell lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
hemiparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cancer pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
cancer pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders None View
neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anorectal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
faeces discoloured NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
large intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
face oedema NON_SYSTEMATIC_ASSESSMENT General disorders None View
gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders None View
localised oedema NON_SYSTEMATIC_ASSESSMENT General disorders None View
oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
hyperphosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
sacral pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
anosmia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dyskinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pulmonary congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
rhonci NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sinus pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
thoracic haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
corneal abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
blood iron decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
eyelid function disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
blood creatine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View