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 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
NCT ID:
NCT02980705
Description:
It is the approximate duration over which adverse event data were collected.
Analysis of adverse events was performed in 3 Parts:
Part 1: SUNPG1622→Placebo; from Day 1 to Week 24 Part 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52 Part 3: Washout period between Week 52 and Week 72. In Part 3 of the study, all subjects underwent IMP washout and no subjects received SUNPG1622.
Frequency Threshold:
0.5
Time Frame:
Week 72
Study:
NCT02980705
Study Brief:
Efficacy and Safety Study of SUNPG1622
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1: SUNPG1622 or Placebo | Group 1: SUNPG1622 or Placebo; From Baseline to Week 24. Safety results are provided per the following: Group 1: Subjects recieved either SUNPG1622 or Placebo | 0 | None | 0 | 101 | 12 | 101 | View |
| Part 2: Treatment Follow-up (SUNPG16221 Dose Injection) | Group 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52. Safety results are provided per the following: Group 2: Subjects recieved SUNPG1622 | 0 | None | 1 | 101 | 13 | 101 | View |
| Part 3: Washout | Group 3: Washout period between Week 52 and Week 72. Safety results are provided per the following: Group 3: washout period | 0 | None | 3 | 101 | 0 | 101 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hyperplasia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fibroadenoma of breast | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Pancreatic carcinoma metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hyperplasia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Glucose tolerance impaired | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injection site joint erythema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |