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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
NCT ID:
NCT02536105
Description:
Adverse events were collected during the entirety of the study, from consent to completion or withdrawal from the study.
Frequency Threshold:
0
Time Frame:
Baseline (Week 0) to Visit 14 (Week 12) or Drop Visit
Study:
NCT02536105
Study Brief:
PK/PD Pediatric ADHD Classroom Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Methylphenidate HCl ER Tablets 1 | During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase Methylphenidate HCl ER tablets 1 | 0 | None | 0 | 80 | 69 | 80 | View |
| Placebo | During the double-blind period, in one of the 4 study weeks, the study participant will take a blinded placebo instead of one of the the 3 active comparators. Placebo | 0 | None | 0 | 74 | 12 | 74 | View |
| Methylphenidate HCl ER Tablets 2 | During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase Methylphenidate HCl ER tablets 2 | 0 | None | 0 | 73 | 20 | 73 | View |
| Methylphenidate HCl ER for Suspension | During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase Methylphenidate HCl ER for suspension | 0 | None | 0 | 74 | 23 | 74 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Low Appetite | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Emotional Lability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Upper Respiratory Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| GI Distress | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomited | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anger/Aggression/Oppositional Behavior | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dysphoria/Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Ankle Pain/Strain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Strep Throat/Sore Throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Motor Tics | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Bug Bites/Bee Stings | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Otitis Media/Ear Pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Carious Teeth | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Growth Hormone Deficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Muscle Strain/Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Mouth Ulcers/Bad Breath | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Eye Pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Flat Affect | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Toe Fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Heart Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Staring Episodes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Sunburn | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Weight Loss | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Foreign Body Swallowed | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Finger Laceration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |