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 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
NCT ID:
NCT03789318
Description:
None
Frequency Threshold:
0
Time Frame:
Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
Study:
NCT03789318
Study Brief:
Study in Subjects Undergoing Complete Abdominoplasty
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CA-008 15 mg (0.15 mg/mL) | Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 15 mg: 15 mg CA-008 reconstituted in saline. | 0 | None | 1 | 12 | 10 | 12 | View |
| Placebo for Cohorts 2 and 3 | Cohorts 2 \& 3: Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery | 0 | None | 0 | 12 | 11 | 12 | View |
| CA-008 5 mg (0.05 mg/mL) Cohort 1 | Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). CA-008 5 mg: 5 mg CA-008 reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery | 0 | None | 2 | 9 | 9 | 9 | View |
| Placebo for Cohort 1 | Cohort 1: Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery | 0 | None | 0 | 9 | 8 | 9 | View |
| CA-008 10 mg (0.1 mg/mL) | Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 10 mg: 10 mg CA-008 reconstituted in saline. | 0 | None | 1 | 12 | 11 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Lip oedema | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.0 | View |
| Incision site cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Abdominal wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Airway complication of anaesthesia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Flap necrosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Incision site pruritus | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Post procedural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Seroma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Respiratory tract congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Pruritus generalized | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Rash macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.0 | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.0 | View |