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 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
NCT ID:
NCT03057366
Description:
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
Frequency Threshold:
0
Time Frame:
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
Study:
NCT03057366
Study Brief:
A Study of [14 C]-Pevonedistat 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 B: Pevonedistat + Paclitaxel and Carboplatin | Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). 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. | 1 | None | 2 | 5 | 5 | 5 | View |
| Part B: Pevonedistat + Docetaxel | Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B. | 1 | None | 1 | 2 | 2 | 2 | View |
| Part A: [14C]-Pevonedistat 25 mg/m^2 | \[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A. | 1 | None | 1 | 8 | 4 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FIBROSARCOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| SARCOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal 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 |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Blood Bilirubin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Platelet Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Blood Urea Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.0) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (21.0) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Mueller's Mixed Tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (21.0) | View |
| Conjunctival Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (21.0) | View |
| Spinal Compression Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| Peripheral Venous Disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.0) | View |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |