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 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
NCT ID:
NCT01654250
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01654250
Study Brief:
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo (OL Phase; DB Phase) | Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week. | None | None | 0 | 44 | 31 | 44 | View |
| NWP09 (OL Phase; DB Phase) | NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week. | None | None | 0 | 42 | 33 | 42 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Increased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Mood swings | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Initial insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Middle insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Aggression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Anger | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Change in sustained attention | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Emotional poverty | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Onychophagia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gingival pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Streptococcal impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Tic | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Aphonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Psychomotor hyperactivity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Feeling jittery | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Burns first degree | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Conjunctival abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Nail injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Radius fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Snake bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Subcutaneous haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Allergic bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Sneezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Excessive eye blinking | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Ocular hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Visual impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 15.0 | View |
| Blood pressure systolic increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 15.0 | View |
| Enuresis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |