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 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
NCT ID:
NCT01104792
Description:
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability.
Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Frequency Threshold:
5
Time Frame:
52 weeks
Study:
NCT01104792
Study Brief:
Long-term Study of Cariprazine 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 |
|---|---|---|---|---|---|---|---|---|
| Cariprazine | Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks. | 0 | None | 59 | 586 | 419 | 586 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Autoimmune thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Medical device pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Comminuted fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Gun shot wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Muscle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Brain injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Hypoglycaemic unconsciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Psychomotor hyperactivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Hallucination, auditory | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Schizophrenia, paranoid type | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Homicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Psychotic behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (14.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Social stay hospitalisation | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (14.0) | View |
| Hospitalisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Akathisia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Extrapyramidal disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |