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:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-25 @ 1:45 PM
NCT ID:
NCT02980692
Description:
None
Frequency Threshold:
5
Time Frame:
72 week
Study:
NCT02980692
Study Brief:
Efficacy and Safety Study of SUNPG1623
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: SUNPG1623 I | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | 0 | None | 2 | 78 | 17 | 78 | View |
| Part 1 : SUNPG1623 II | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | 0 | None | 2 | 79 | 18 | 79 | View |
| Part 1 : SUNPG1623 Dose III | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | 0 | None | 2 | 77 | 16 | 77 | View |
| Part 1 : SUNPG1623 Dose IV | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48 | 0 | None | 1 | 78 | 22 | 78 | View |
| Part 1 : Placebo | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48 | 0 | None | 2 | 79 | 18 | 79 | View |
| Part 2: SUNPG1623 I | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | 0 | None | 0 | 78 | 14 | 78 | View |
| Part 2 : SUNPG1623 II | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | 0 | None | 0 | 79 | 11 | 79 | View |
| Part 2 : SUNPG1623 Dose III | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | 0 | None | 0 | 77 | 6 | 77 | View |
| Part 2: Week 24 - 48: SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24 | Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48 | 0 | None | 3 | 78 | 18 | 78 | View |
| Part 2: Week 24 - 48: Placebo Moved to SUNPG1623 II After Week 24 | Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48 | 0 | None | 1 | 79 | 9 | 79 | View |
| Part 3: SUNPG1623 I | Wash-out period | 1 | None | 3 | 78 | 8 | 78 | View |
| Part 3 : SUNPG1623 II | Wash-out period | 0 | None | 1 | 79 | 1 | 79 | View |
| Part 3 : SUNPG1623 Dose III | Wash-out period | 0 | None | 1 | 77 | 3 | 77 | View |
| Part 3 :Wash-out Period (SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24) | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Part 2 : Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48 Part 3 : wash-out period | 0 | None | 1 | 78 | 8 | 78 | View |
| Part 3 : Wash-out Period (Placebo Moved to SUNPG1623 II After Week 24) | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Part 2 : Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48 Part 3 : wash-out period | 0 | None | 2 | 79 | 8 | 79 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ovarian cyst ruptured | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Multiple sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chronic tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Intraductal proliferative breast lesion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Parathyroid tumour benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Lumbar radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sleep Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |