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 @ 11:19 PM
Ignite Modification Date: 2025-12-25 @ 9:01 PM
NCT ID: NCT01489956
Description: Adverse events reported for all enrolled subjects
Frequency Threshold: 5
Time Frame: Enrollment through last study visit (up to 6 months after last immunization)
Study: NCT01489956
Study Brief: A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Immucothel Alone (Part A) Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete. None None 0 13 4 13 View
Immucothel + Montanide (Part A) If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed. None None 0 0 0 0 View
Immucothel Alone or Immucothel + Montanide (Part B) Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35. None None 0 6 4 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Basophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Basophil percentage increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Eosinophil percentage increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Haematocrit increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Mean cell haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Red blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Breast reconstruction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View