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 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
NCT ID:
NCT01377233
Description:
Adverse events were monitored at all study visits incl. screening, baseline, completion/withdrawal and safety follow-up visits. All adverse events observed by investigators or reported by patients were recorded. Results from relevant clinical safety tests were also recorded as adverse events if considered clinically significant by the investigator.
Frequency Threshold:
5
Time Frame:
Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)
Study:
NCT01377233
Study Brief:
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine 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 |
|---|---|---|---|---|---|---|---|---|
| Zicronapine Open-label 10 mg Daily | Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label | None | None | 0 | 46 | 8 | 46 | View |
| Zicronapine Basis Dose 10 mg Daily | Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind | None | None | 0 | 11 | 8 | 11 | View |
| Zicronapine Low Dose 20 mg Once Weekly | Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind | None | None | 1 | 10 | 4 | 10 | View |
| Zicronapine Med Dose 30 mg Once Weekly | Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind | None | None | 1 | 11 | 4 | 11 | View |
| Zicronapine High Dose 45 mg Once Weekly | Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind | None | None | 1 | 10 | 9 | 10 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Accidental Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Limb Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Road Traffic Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Rheumatoid Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Sedation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Tardive Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Drug Abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Libido Decreased | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Psychotic Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Treatment Noncompliance | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (14.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Musculoskeletal Stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Trismus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Pruritus Generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |