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 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
NCT ID:
NCT01412060
Description:
Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study.
Double-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
Adverse events data was reported in periods as per the treatment received.
Frequency Threshold:
5
Time Frame:
First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
Study:
NCT01412060
Study Brief:
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants 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 - Open-label Phase | Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase. | 0 | None | 50 | 765 | 425 | 765 | View |
| Placebo - Double-blind Treatment Phase | Participants received placebo orally once a day for 26 to 72 weeks. | 0 | None | 14 | 99 | 28 | 99 | View |
| Cariprazine - Double-blind Treatment Phase | Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks. | 0 | None | 14 | 101 | 35 | 101 | View |
| Open-label - Safety Follow-up Phase | Participants received no treatment during the 4 weeks Safety Follow-up Phase. | 0 | None | 6 | 765 | 0 | 765 | View |
| Placebo - Safety Follow-up Phase | Participants received no treatment during the 4 weeks Safety Follow-up Phase. | 0 | None | 2 | 99 | 0 | 99 | View |
| Cariprazine - Safety Follow-up Phase | Participants received no treatment during the 4 weeks Safety Follow-up Phase. | 0 | None | 0 | 101 | 0 | 101 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Psychiatric evaluation | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Psychotic behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (17.1) | View |
| Generalised tonic-clonic seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Middle ear effusion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (17.1) | View |
| Otitis media acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| Tachycardia paroxysmal | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Schizophrenia, paranoid type | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Social stay hospitalisation | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (17.1) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Drug abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Extrapyramidal disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Foreign body | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Intentional product misuse | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (17.1) | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Victim of crime | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (17.1) | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Drug ineffective | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.1) | View |
| Multiple injuries | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Akathisia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Extrapyramidal disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |