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 @ 12:58 AM
Ignite Modification Date: 2025-12-25 @ 11:12 PM
NCT ID: NCT03170193
Description: Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Frequency Threshold: 5
Time Frame: From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Study: NCT03170193
Study Brief: AMG 529 First in Human Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received a single dose of matching placebo by either subcutaneous or intravenous injection. 0 None 0 12 3 12 View
AMG 529 21 mg SC Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection. 0 None 0 6 0 6 View
AMG 529 70 mg SC Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection. 0 None 0 6 0 6 View
AMG 529 210 mg SC Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection. 0 None 0 6 2 6 View
AMG 529 420 mg SC Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection. 0 None 0 6 2 6 View
AMG 529 700 mg SC Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection. 0 None 0 6 3 6 View
AMG 529 70 mg IV Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection. 0 None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View