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 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
NCT ID:
NCT04199351
Description:
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
Frequency Threshold:
5
Time Frame:
All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
Study:
NCT04199351
Study Brief:
Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity
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 1 (Part A): AMG 171 Dose A | Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1. | 0 | None | 0 | 7 | 5 | 7 | View |
| Cohort 1b (Part A): AMG 171 Dose B | Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1. | 0 | None | 0 | 6 | 6 | 6 | View |
| Placebo (Cohort 4 Replaced) | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses. | 0 | None | 0 | 2 | 0 | 2 | View |
| Placebo (Cohorts 2-5) | Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo. | 0 | None | 0 | 8 | 3 | 8 | View |
| Cohort 2 (Part B): AMG 171 Dose A Q2W | Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses. | 0 | None | 0 | 7 | 7 | 7 | View |
| Cohort 3 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses. | 0 | None | 0 | 8 | 5 | 8 | View |
| Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C | Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 5 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. | 0 | None | 0 | 6 | 5 | 6 | View |
| Placebo (Cohort 1 and 1b) | Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1. | 0 | None | 0 | 4 | 0 | 4 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 24.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Bowel movement irregularity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Libido decreased | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 24.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |