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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT04478708
Description:
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
Frequency Threshold:
5
Time Frame:
All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Study:
NCT04478708
Study Brief:
Single and Multiple Ascending Dose Study of AMG 133 in Participants 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 |
|---|---|---|---|---|---|---|---|---|
| Part A SAD Cohort 1 AMG 133 | Participants received a single dose of 21 mg AMG 133 SC. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part A SAD Cohort 2 AMG 133 | Participants received a single dose of 70 mg AMG 133 SC. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part A SAD Cohort 3 AMG 133 | Participants received a single dose of 140 mg AMG 133 SC. | 0 | None | 0 | 7 | 5 | 7 | View |
| Part A SAD Cohort 4 AMG 133 | Participants received a single dose of 280 mg AMG 133 SC. | 0 | None | 0 | 6 | 6 | 6 | View |
| Part A SAD Cohort 5 AMG 133 | Participants received a single dose of 560 mg AMG 133 SC. | 0 | None | 0 | 6 | 5 | 6 | View |
| Part A SAD Cohort 6 AMG 133 | Participants received a single dose of 70 mg AMG 133 IV. | 0 | None | 0 | 6 | 6 | 6 | View |
| Part A SAD SC Placebo (Cohorts 1-5, 11) | Participants received a single dose of placebo SC. | 0 | None | 0 | 12 | 3 | 12 | View |
| Part A SAD IV Placebo (Cohort 6) | Participants received a single dose of placebo IV. | 0 | None | 0 | 2 | 1 | 2 | View |
| Part B MAD Cohort 7 AMG 133 | Participants received multiple doses of 140 mg AMG 133 SC Q4W. | 0 | None | 0 | 6 | 6 | 6 | View |
| Part B MAD Cohort 8 AMG 133 | Participants received multiple doses of 280 mg AMG 133 SC Q4W. | 0 | None | 0 | 6 | 6 | 6 | View |
| Part B MAD Cohort 9 AMG 133 | Participants received multiple doses of 560 mg AMG 133 SC Q4W. | 0 | None | 0 | 8 | 8 | 8 | View |
| Part B MAD Cohort 10 AMG 133 | Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools. | 0 | None | 0 | 10 | 8 | 10 | View |
| Part B MAD Cohorts 7-9 Placebo | Participants received multiple doses of placebo SC Q4W. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part B MAD Cohort 10 Placebo | Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools. | 0 | None | 0 | 3 | 0 | 3 | View |
| Part A SAD Cohort 11 AMG 133 | Participants received a single dose of 840 mg AMG 133 SC. | 0 | None | 0 | 6 | 6 | 6 | View |
| Part C MAD Cohort 12 | Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W. | 0 | None | 0 | 6 | 5 | 6 | View |
| Part C MAD Cohort 13 | Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W. | 0 | None | 0 | 8 | 6 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Eructation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Early satiety | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Breath sounds absent | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Parosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Throat tightness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |