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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
NCT ID: NCT01470651
Description: Side effects form listed: Nervousness, Irritability, Headaches, Nausea, Insomnia, Shortness of Breath, Difficulty Concentrating, Appetite/weight loss, Taste change, Dry mouth, Diarrhea, muscle aches, rash, fever, rectal pain, and two "other" fields. Side effect onset was defined as a two point increase (on a 5 point scale) from baseline.
Frequency Threshold: 0
Time Frame: Baseline readings were collected two weeks before randomization to placebo or Armodafinil until 16 weeks after randomization. Measurements weekly until post-randomization week 12 at which point they were taken every other week.
Study: NCT01470651
Study Brief: Armodafinil for Patients Starting Hepatitis C Virus Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Armodafinil Active medication Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks None None 0 13 12 13 View
Sugar Pill Inactive pill, matched to look like active medication Placebo Comparator: Inactive pill, matched to look like active medication None None 0 13 13 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Appetite or weight change SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Taste Change SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fever SYSTEMATIC_ASSESSMENT Immune system disorders None View
Rectal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty in Concentration SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tingling Feeling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Plantar Fascitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Allergy Symptoms SYSTEMATIC_ASSESSMENT Immune system disorders None View
Testicular Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Emotional instability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Swollen Eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Altered Sense of Smell SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizzyness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
feeling cold SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View