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 @ 10:40 PM
Ignite Modification Date: 2025-12-25 @ 8:11 PM
NCT ID: NCT01059435
Description: Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Frequency Threshold: 5
Time Frame: Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Study: NCT01059435
Study Brief: A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Romosozumab 0.1 mg/kg SC Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab. None None 0 6 4 6 View
Romosozumab 0.3 mg/kg SC Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab. None None 0 6 4 6 View
Romosozumab 1.0 mg/kg SC Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab. None None 0 9 1 9 View
Romosozumab 10.0 mg/kg SC Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab. None None 1 6 5 6 View
Romosozumab 3.0 mg/kg SC Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab. None None 0 6 5 6 View
Romosozumab 5.0 mg/kg SC Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab. None None 0 9 6 9 View
Romosozumab 1.0 mg/kg IV Participants received a single intravenous injection of 1.0 mg/kg romosozumab. None None 0 6 1 6 View
Romosozumab 5.0 mg/kg IV Participants received a single intravenous injection of 5.0 mg/kg romosozumab. None None 0 6 2 6 View
Placebo SC Participants received a single subcutaneous (SC) injection of matching placebo. None None 0 14 9 14 View
Placebo IV Participants received a single intravenous (IV) injection of matching placebo. None None 0 4 2 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
HEPATITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
LIP DRY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
TINEA PEDIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
DERMATITIS CONTACT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.0 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 17.0 View
IRON DEFICIENCY ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 17.0 View
BASEDOW'S DISEASE SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 17.0 View
BLEPHARITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
APHTHOUS STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
ORAL DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
AXILLARY PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
INJECTION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
INJECTION SITE HAEMORRHAGE SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
INJECTION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
THIRST SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
ESCHERICHIA URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
HORDEOLUM SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
MUSCULOSKELETAL DISCOMFORT SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
BREAST TENDERNESS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 17.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
PHARYNGOLARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
DERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View