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: 2025-12-26 @ 5:18 PM
Ignite Modification Date: 2025-12-26 @ 5:18 PM
NCT ID: NCT03330106
Description: Safety Population for Part A included all participants who received at least 1 dose of pevonedistat during Part A. Safety population for Part B included all participants who continued to Part B and received at least 1 dose of study drugs during Part B. For Part A, MedDRA Version 22.0 was used and for Part B MedDRA version 24.0 was used.
Frequency Threshold: 5
Time Frame: From first dose of study drug up to approximately 188 weeks (up to approximately 3.6 years)
Study: NCT03330106
Study Brief: A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A: Pevonedistat 25 mg/m^2 + Pevonedistat 50 mg/m^2 Pevonedistat 25 mg/m\^2, infusion, intravenously (IV), once on Day 1, followed by pevonedistat 50 mg/m\^2, infusion, IV, once on Day 8 in Part A. 2 None 3 22 13 22 View
Part A: Pevonedistat 50 mg/m^2 + Pevonedistat 25 mg/m^2 Pevonedistat 50 mg/m\^2, infusion, IV, once on Day 1, followed by pevonedistat 25 mg/m\^2, infusion, IV, once on Day 8 in Part A. 4 None 5 22 17 22 View
Part B: Pevonedistat 25 mg/m^2 + Docetaxel Pevonedistat 25 mg/m\^2 in combination with docetaxel 75 mg/m\^2, infusion, IV, once on Day 1 followed by pevonedistat 25 mg/m\^2 IV, once on Days 3 and 5 in each 21-day treatment cycle for up to Cycle 45 or symptomatic deterioration or progressive disease (PD), or until treatment is discontinued for another reason. Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B. 2 None 13 23 23 23 View
Part B: Pevonedistat 20 mg/m^2 + Carboplatin + Paclitaxel Pevonedistat 20 mg/m\^2 in combination with carboplatin area under the plasma concentration (AUC) at the dose of 5 mg/min/mL, infusion, IV and paclitaxel 175 mg/m\^2, infusion, IV, once on Day 1 in each 21-day treatment cycle followed by pevonedistat 20 mg/m\^2 IV, once on Days 3 and 5 in each 21-day treatment cycle for up to 20 cycles or symptomatic deterioration or PD, or until treatment is discontinued for another reason. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B. 0 None 5 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Fallopian tube cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA22.0 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA22.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Disseminated varicella zoster virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA22.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA22.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA22.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA22.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA22.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA22.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Drooling SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Vitamin D decreased SYSTEMATIC_ASSESSMENT Investigations 22.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA22.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA22.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA22.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA22.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA22.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA22.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA22.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA22.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA22.0 View
Macule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA22.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA22.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA22.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA22.0 View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA22.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA22.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA22.0 View
Incision site oedema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA22.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA22.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA22.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA22.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA22.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA22.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA22.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA22.0 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA22.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA22.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA22.0 View