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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT02937766
Description: None
Frequency Threshold: 0
Time Frame: Approximately 66 days
Study: NCT02937766
Study Brief: Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal 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
Treatment A Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) None None 1 30 17 30 View
Treatment B Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) None None 0 30 13 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site paraesthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site pruritis SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 19.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 19.0 View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 19.0 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 19.0 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 19.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 19.0 View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 19.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 19.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 19.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 19.0 View