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 @ 10:49 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT03137069
Description: One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
Frequency Threshold: 5
Time Frame: Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
Study: NCT03137069
Study Brief: A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 2: GDC-0853 200mg BID Participants received GDC-0853 200mg twice daily from Day 1 to 56. 0 None 0 24 12 24 View
Cohort 1: Placebo Participants received matching placebo twice daily from Day 1 to 56. 0 None 0 13 8 13 View
Cohort 1: GDC-0853 200mg BID Participants received GDC-0853 200mg twice daily from Day 1 to 56. 0 None 3 28 16 28 View
Cohort 2: Placebo Participants received matching placebo up to twice daily from Day 1 to 56. 0 None 0 22 7 22 View
Cohort 2: GDC-0853 50mg QD Participants received GDC-0853 50mg once daily from Day 1 to 56. 0 None 0 23 7 23 View
Cohort 2: GDC-0853 150mg QD Participants received GDC-0853 150mg once daily from Day 1 to 56. 0 None 0 24 13 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
PERIORBITAL CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
FEELING ABNORMAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
EYE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
BONE CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
CHRONIC SPONTANEOUS URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View