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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
NCT ID:
NCT05368558
Description:
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
Frequency Threshold:
5
Time Frame:
All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
Study:
NCT05368558
Study Brief:
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult 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 |
|---|---|---|---|---|---|---|---|---|
| DBP Placebo | Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP). | 0 | None | 0 | 16 | 12 | 16 | View |
| DBP Cariprazine 3 mg | Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP. | 0 | None | 0 | 5 | 2 | 5 | View |
| DBP Cariprazine 6 mg | Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP. | 0 | None | 0 | 13 | 10 | 13 | View |
| BEP Cariprazine 3 mg | Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal modal (most frequent) daily dose during the 18-week BEP. | 0 | None | 1 | 4 | 3 | 4 | View |
| SF DBP Placebo | Safety Follow up (SF) for DBP Placebo participants. | 0 | None | 0 | 5 | 3 | 5 | View |
| SF DBP Cariprazine 3 mg | SF for DBP Cariprazine 3 mg participants. | 0 | None | 0 | 1 | 0 | 1 | View |
| SF DBP Cariprazine 6 mg | SF for DBP Cariprazine 6 mg participants. | 0 | None | 1 | 4 | 2 | 4 | View |
| SF BEP Cariprazine 1.5 mg | SF for BEP Cariprazine 1.5 mg participants. | 0 | None | 0 | 10 | 4 | 10 | View |
| SF BEP Cariprazine 3 mg | SF for BEP Cariprazine 3 mg participants. | 0 | None | 1 | 4 | 0 | 4 | View |
| SF BEP Cariprazine 6 mg | SF for BEP Cariprazine 6 mg participants. | 0 | None | 0 | 10 | 2 | 10 | View |
| BEP Cariprazine 1.5 mg | Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal modal (most frequent) daily dose during the 18-week BEP. | 0 | None | 1 | 10 | 7 | 10 | View |
| BEP Cariprazine 6 mg | Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal (most frequent) daily dose during the 18-week BEP. | 0 | None | 0 | 10 | 6 | 10 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 27.0 | View |
| IRIDOCYCLITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 27.0 | View |
| UVEITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 27.0 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 27.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| DENTAL CARIES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| MOUTH ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| FEELING ABNORMAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| HORDEOLUM | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| PERIODONTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 27.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 27.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| AKATHISIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| EXTRAPYRAMIDAL DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| DYSMENORRHOEA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 27.0 | View |
| SCROTAL ERYTHEMA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 27.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | View |
| DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| DERMATITIS ATOPIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| SKIN FISSURES | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.0 | View |
| CHILLBLAINS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| IMMUNISATION REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| POST VACCINATION SYNDROME | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| POST-TRAUMATIC PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| SKIN ABRASION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| WOUND | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| BLOOD CHLORIDE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| BLOOD SODIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| HIGH DENSITY LIPOPROTEIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| WHITE BLOOD CELL COUNT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| PARKINSONISM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| AGITATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| LOGORRHOEA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| NIGHTMARE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| RESTLESSNESS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| SCHIZOPHRENIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |