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: 2025-12-24 @ 9:45 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT01857232
Description: None
Frequency Threshold: 5.0
Time Frame: 7 Days
Study: NCT01857232
Study Brief: Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
APD403 20MG ACUTE (day 1): IV OND + APD403 20 mg • DELAYED (days 2 to 4): Oral APD403 20 mg 0 None 3 68 21 68 View
Control ACUTE (day 1): IV OND + FOS + DEX • DELAYED (days 2 to 4): Oral DEX 2 None 8 66 36 66 View
Placebo ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo 0 None 12 66 47 66 View
APD403 10MG ACUTE (day 1): IV OND + APD403 20 mg • DELAYED (days 2 to 4): Oral APD403 10 mg 0 None 2 63 34 63 View
ADP403 40MG ACUTE (day 1): IV OND + APD403 20 mg • DELAYED (days 2 to 4): Oral APD403 40 mg 0 None 4 65 28 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Electrocardiogram QT Prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Blood Creatine Increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.1 View
Duodenal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Blood Prolactin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
General Physical Condition Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Mucosal Dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View