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 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
NCT ID:
NCT02007434
Description:
None
Frequency Threshold:
0
Time Frame:
84 days
Study:
NCT02007434
Study Brief:
Patient Experience Study of Deoxycholic Acid Injection
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. | None | None | 0 | 17 | 17 | 17 | View |
| Paradigm 1 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. | None | None | 0 | 3 | 3 | 3 | View |
| Paradigm 2 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. | None | None | 0 | 17 | 17 | 17 | View |
| Paradigm 2 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. | None | None | 0 | 4 | 4 | 4 | View |
| Paradigm 3 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. | None | None | 0 | 16 | 16 | 16 | View |
| Paradigm 3 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | None | None | 0 | 4 | 4 | 4 | View |
| Paradigm 4 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | None | None | 0 | 18 | 18 | 18 | View |
| Paradigm 4 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | None | None | 0 | 4 | 4 | 4 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Application site alopecia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site anaesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site dysaesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Skin tightness | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Injection site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (16.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |