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: 2025-12-25 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT00659802
Description: None
Frequency Threshold: 2.5
Time Frame: 12 weeks
Study: NCT00659802
Study Brief: Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Dose HMPL-004 (1200 mg/Day) HMPL-004 : HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). 0 None 2 75 45 75 View
High Dose HMPL-004 (1800 mg/Day) HMPL-004 : HMPL-004, 600 mg (3 x 200 mg) t.i.d. total of 1800 mg/day. 0 None 2 74 39 74 View
Placebo Placebo, t.i.d. 0 None 2 75 45 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Pilonidal cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Hematocrit decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Grand mal convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Ageusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Gamma-glutamyl transferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Hematocrit decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Edema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Basophilia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View