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 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
NCT ID:
NCT01986933
Description:
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality.
Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
Frequency Threshold:
5
Time Frame:
baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
Study:
NCT01986933
Study Brief:
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B) | Data from Part A, Part B and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. | 0 | None | 3 | 53 | 37 | 53 | View |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B) | Data from Part A, Part B and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. | 0 | None | 3 | 54 | 35 | 54 | View |
| Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B) | Data from Part A, Part B and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B. | 0 | None | 9 | 52 | 35 | 52 | View |
| Placebo (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 0 | None | 1 | 53 | 27 | 53 | View |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 0 | None | 0 | 54 | 23 | 54 | View |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 0 | None | 3 | 52 | 27 | 52 | View |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 0 | None | 1 | 53 | 29 | 53 | View |
| Nemoliozumab (2.0 mg/kg) Q8W (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. | 0 | None | 5 | 52 | 25 | 52 | View |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B) | Data from Part A, Part B and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. | 0 | None | 4 | 52 | 33 | 52 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dermatitis exfoliative | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pyoderma | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Grand mal convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Non-alcoholic steatohepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |