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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT01029704
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
Study: NCT01029704
Study Brief: Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Segment 1 (Dose Escalation): EGT0001442 10mg Received 10mg of EGT0001442 once daily for 28 days 0 None 0 5 3 5 View
Segment 1 (Dose Escalation): EGT0001442 20mg Received 20mg of EGT0001442 once daily for 28 days 0 None 0 5 3 5 View
Segment 1 (Dose Escalation): EGT0001442 50mg Received 50mg of EGT0001442 once daily for 28 days 0 None 0 5 2 5 View
Placebo Received no drug (EGT0001442) during 28 days 0 None 0 28 4 28 View
EGT0001442 5mg Received 5mg of EGT0001442 per day for 28 days 0 None 1 24 3 24 View
EGT0001442 10mg Received 10mg of EGT0001442 per day for 28 days 0 None 1 23 6 23 View
EGT0001442 20mg Received 20mg of EGT0001442 per day for 28 days 0 None 0 28 6 28 View
EGT0001442 50mg Received 50mg of EGT0001442 per day for 28 days 0 None 0 26 6 26 View
Segment 1 (Dose Escalation): EGT0001442 5mg Received 5mg of EGT0001442 once daily for 28 days 0 None 0 5 3 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leucopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Balanitis candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Vulvovaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View