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 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
NCT ID:
NCT04132518
Description:
Safety population included all participants in Group B who were treated with Sculptra or randomized to no-treatment group and participant in Group A who were treated with Sculptra.
Frequency Threshold:
5
Time Frame:
From start of study product administration up to 2 years 4 months
Study:
NCT04132518
Study Brief:
Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group A: Sculptra | Participants in Group A received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. | 0 | None | 2 | 16 | 10 | 16 | View |
| Group B: Sculptra | Participants in Group B received up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and were followed up for 24 months. | 0 | None | 7 | 124 | 15 | 124 | View |
| Group B: Control | Participants in Group B did not receive any treatment and followed up for 12 months. | 0 | None | 0 | 63 | 4 | 63 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | 22.0 | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 22.0 | View |
| Removal of internal fixation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 22.0 | View |
| Gallbladder polyp | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.0 | View |
| Cardiac neoplasm unspecific | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.0 | View |
| Lumbar vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 22.0 | View |
| Basedow's disease | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 22.0 | View |
| Meningioma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Implant site nodule | NON_SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.0 | View |
| Eyelid oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | 22.0 | View |
| Xerophthalmia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | 22.0 | View |
| Cheilitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Large intestine polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Gallbladder polyp | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Vulvovaginal mycotic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Animal bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 22.0 | View |
| Calcium deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Synovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Cervix disorder | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 22.0 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Alopecia areata | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Seborrhoeic dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Skin fissures | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Arteriosclerosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Tooth disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Menopausal symptoms | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 22.0 | View |
| Menstrual disorder | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 22.0 | View |
| Pulmonary fibrosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |