Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT01582269
Description: * Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Frequency Threshold: 5
Time Frame: Baseline Up to 11 years 4 months
Study: NCT01582269
Study Brief: A Study in Recurrent Glioblastoma (GB)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A: Galunisertib * Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle. * Treatment continued until disease progression, death, or discontinuation criteria were met. 37 None 21 40 34 40 View
Arm B: Galunisertib + Lomustine * Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle. * Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator. * Treatment continued until disease progression, death, or discontinuation criteria were met. 75 None 31 78 69 78 View
Arm C: Lomustine + Placebo * Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator. * Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle. * Treatment continued until disease progression, death, or discontinuation criteria were met. 38 None 15 39 31 39 View
Arm C: Lomustine + Placebo (Placebo Alone) • Participants randomized to Arm C who did not receive the planned treatment but received Galunisertib-matched placebo alone were categorized under this group. 1 None 1 1 0 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Clostridium colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Varicella zoster virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Meningitis chemical SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Eastern cooperative oncology group performance status worsened SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Electrocardiogram repolarisation abnormality SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Facial paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Iiird nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Non-24-hour sleep-wake disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Psychotic disorder due to a general medical condition SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Subdural hygroma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Hirsutism SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View