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 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
NCT ID:
NCT05419505
Description:
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
Frequency Threshold:
5
Time Frame:
From Day 1 (after dose) through Day 180
Study:
NCT05419505
Study Brief:
Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1: CCH-aaes Dose Evaluation-Test (ISR) | Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mL). | 0 | None | 0 | 0 | 22 | 22 | View |
| Cohort 1: CCH-aaes Dose Evaluation-Control (ISR) | Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 0 | None | 0 | 0 | 22 | 22 | View |
| Cohort 2: CCH-aaes Concentration Evaluation-Test (ISR) | Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL). | 0 | None | 0 | 0 | 13 | 14 | View |
| Cohort 2: CCH-aaes Concentration Evaluation -Control (ISR) | Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 0 | None | 0 | 0 | 13 | 14 | View |
| Cohort 3: CCH-aaes Injection Depth Evaluation-Test (ISR) | Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch. | 0 | None | 0 | 0 | 5 | 5 | View |
| Cohort 3: CCH-aaes Injection Depth Evaluation-Control (ISR) | Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch. | 0 | None | 0 | 0 | 5 | 5 | View |
| Cohort 4: CCH-aaes Injection Method Evaluation-Test (ISR) | Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections. | 0 | None | 0 | 0 | 7 | 7 | View |
| Cohort 4: CCH-aaes Injection Method Evaluation-Control (ISR) | Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections. | 0 | None | 0 | 0 | 7 | 7 | View |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation-Test (ISR) | Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive. | 0 | None | 0 | 0 | 10 | 10 | View |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation-Control (ISR) | Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 0 | None | 0 | 0 | 10 | 10 | View |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation -Test (ISR) | Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart. | 0 | None | 0 | 0 | 19 | 19 | View |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation-Control (ISR) | Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart. | 0 | None | 0 | 0 | 19 | 19 | View |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Test (ISR) | Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen. | 0 | None | 0 | 0 | 7 | 7 | View |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Control (ISR) | Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 0 | None | 0 | 0 | 6 | 7 | View |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Test (ISR) | Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen. | 0 | None | 0 | 0 | 7 | 7 | View |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Control (ISR) | Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 0 | None | 0 | 0 | 7 | 7 | View |
| Cohort 1: Systemic/Non-ISR AEs | Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 1. | 0 | None | 0 | 22 | 4 | 22 | View |
| Cohort 2: Systemic/Non-ISR AEs | Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 2. | 0 | None | 0 | 14 | 0 | 14 | View |
| Cohort 3: Systemic/Non-ISR AEs | Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 3. | 0 | None | 0 | 5 | 3 | 5 | View |
| Cohort 4: Systemic/Non-ISR AEs | Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 4. | 0 | None | 0 | 7 | 0 | 7 | View |
| Cohort 5: Systemic/Non-ISR AEs | Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 5. | 0 | None | 0 | 10 | 0 | 10 | View |
| Cohort 6: Systemic/Non-ISR AEs | Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 6. | 0 | None | 0 | 19 | 4 | 19 | View |
| Cohort 7a: Systemic/Non-ISR AEs | Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 7a. | 0 | None | 0 | 7 | 0 | 7 | View |
| Cohort 7b: Systemic/Non-ISR AEs | Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 7b. | 0 | None | 0 | 7 | 2 | 7 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Benign breast neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |
| Insulin resistance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Bacterial vaginosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site discolouration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site papule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |