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 @ 2:29 PM
Ignite Modification Date:
2025-12-25 @ 1:03 PM
NCT ID:
NCT01626859
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01626859
Study Brief:
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MP-214 3mg | MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks. | None | None | 0 | 11 | 11 | 11 | View |
| MP-214 6mg | MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks. | None | None | 2 | 16 | 15 | 16 | View |
| MP-214 9mg | MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks. | None | None | 0 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Schizophrenia | None | Psychiatric disorders | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sinus tachycardia | None | Cardiac disorders | MedDRA 16.1 | View |
| Hyperprolactinaemia | None | Endocrine disorders | MedDRA 16.1 | View |
| Abnormal sensation in eye | None | Eye disorders | MedDRA 16.1 | View |
| Cataract | None | Eye disorders | MedDRA 16.1 | View |
| Conjunctivitis | None | Eye disorders | MedDRA 16.1 | View |
| Abdominal discomfort | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Abdominal tenderness | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dental caries | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Faeces hard | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Gastritis | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Haematochezia | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Irritable bowel syndrome | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Mucous stools | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Paraesthesia oral | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Salivary hypersecretion | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 16.1 | View |
| Chest discomfort | None | General disorders | MedDRA 16.1 | View |
| Chills | None | General disorders | MedDRA 16.1 | View |
| Feeling abnormal | None | General disorders | MedDRA 16.1 | View |
| Irritability | None | General disorders | MedDRA 16.1 | View |
| Malaise | None | General disorders | MedDRA 16.1 | View |
| Pyrexia | None | General disorders | MedDRA 16.1 | View |
| Hepatic function abnormal | None | Hepatobiliary disorders | MedDRA 16.1 | View |
| Seasonal allergy | None | Immune system disorders | MedDRA 16.1 | View |
| Enteritis infectious | None | Infections and infestations | MedDRA 16.1 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 16.1 | View |
| Hordeolum | None | Infections and infestations | MedDRA 16.1 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA 16.1 | View |
| Pulpitis dental | None | Infections and infestations | MedDRA 16.1 | View |
| Tinea infection | None | Infections and infestations | MedDRA 16.1 | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Excoriation | None | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Laceration | None | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Ligament sprain | None | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Thermal burn | None | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Tooth fracture | None | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA 16.1 | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA 16.1 | View |
| Blood cholesterol increased | None | Investigations | MedDRA 16.1 | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA 16.1 | View |
| Blood lactate dehydrogenase increased | None | Investigations | MedDRA 16.1 | View |
| Blood prolactin increased | None | Investigations | MedDRA 16.1 | View |
| Blood triglycerides increased | None | Investigations | MedDRA 16.1 | View |
| Blood uric acid increased | None | Investigations | MedDRA 16.1 | View |
| Blood urine present | None | Investigations | MedDRA 16.1 | View |
| Gamma-glutamyltransferase increased | None | Investigations | MedDRA 16.1 | View |
| Heart rate increased | None | Investigations | MedDRA 16.1 | View |
| Liver function test abnormal | None | Investigations | MedDRA 16.1 | View |
| Red blood cell count increased | None | Investigations | MedDRA 16.1 | View |
| Thyroxine free increased | None | Investigations | MedDRA 16.1 | View |
| Weight decreased | None | Investigations | MedDRA 16.1 | View |
| White blood cell count increased | None | Investigations | MedDRA 16.1 | View |
| Dyslipidaemia | None | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Electrolyte depletion | None | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Metabolic disorder | None | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Akathisia | None | Nervous system disorders | MedDRA 16.1 | View |
| Athetosis | None | Nervous system disorders | MedDRA 16.1 | View |
| Dizziness | None | Nervous system disorders | MedDRA 16.1 | View |
| Dizziness postural | None | Nervous system disorders | MedDRA 16.1 | View |
| Dyskinesia | None | Nervous system disorders | MedDRA 16.1 | View |
| Extrapyramidal disorder | None | Nervous system disorders | MedDRA 16.1 | View |
| Facial spasm | None | Nervous system disorders | MedDRA 16.1 | View |
| Headache | None | Nervous system disorders | MedDRA 16.1 | View |
| Restless legs syndrome | None | Nervous system disorders | MedDRA 16.1 | View |
| Sedation | None | Nervous system disorders | MedDRA 16.1 | View |
| Somnolence | None | Nervous system disorders | MedDRA 16.1 | View |
| Tremor | None | Nervous system disorders | MedDRA 16.1 | View |
| Hallucination, visual | None | Psychiatric disorders | MedDRA 16.1 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 16.1 | View |
| Restlessness | None | Psychiatric disorders | MedDRA 16.1 | View |
| Schizophrenia | None | Psychiatric disorders | MedDRA 16.1 | View |
| Suicidal ideation | None | Psychiatric disorders | MedDRA 16.1 | View |
| Urinary retention | None | Renal and urinary disorders | MedDRA 16.1 | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Cold sweat | None | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Haemorrhage subcutaneous | None | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Hyperkeratosis | None | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Ingrowing nail | None | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Seborrhoeic dermatitis | None | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Skin erosion | None | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Hot flush | None | Vascular disorders | MedDRA 16.1 | View |
| Hypertension | None | Vascular disorders | MedDRA 16.1 | View |