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 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
NCT ID:
NCT04206332
Description:
Solicited AEs collected through systematic assessment for IP recipients and unsolicited AEs collected for IP and/or CHMI recipients through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Counted twice: 10 in Part A who enrolled in Part B. Not counted: Group 6 and some in Groups 5 (n=8), 7 (n=3) and 14 (n=1) who received no IP/CHMI.
Frequency Threshold:
5
Time Frame:
Unsolicited adverse event (AE) data collection included AEs of all severities for the CIS43LS and/or CHMI recipients only. Unsolicited AEs were recorded from the date of investigational product (IP) administration through the Day 28 post-product administration visit and from CHMI through the Day 28 post-CHMI visit. After and between the indicated time periods, only serious AEs (SAEs) and new chronic medical conditions were recorded as AEs through the last expected study visit at Week 24.
Study:
NCT04206332
Study Brief:
Trial to Evaluate CIS43LS in Healthy Adults
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 A, Group 1: CIS43LS (5 mg/kg IV) | CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. | 0 | None | 0 | 4 | 4 | 4 | View |
| Part A, Group 2: CIS43LS (5 mg/kg SC) | CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. | 0 | None | 0 | 4 | 4 | 4 | View |
| Part A, Group 3: CIS43LS (20 mg/kg IV) | CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.. | 0 | None | 0 | 5 | 2 | 5 | View |
| Part A, Group 4A: CIS43LS (40 mg/kg IV) | CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. | 0 | None | 0 | 5 | 3 | 5 | View |
| Part C, Group 16: CHMI Controls | Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI) Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 6 | 0 | 6 | View |
| Part A, Group 4B: CIS43LS (40 mg/kg IV) | CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. | 0 | None | 0 | 3 | 2 | 3 | View |
| Part B, Group 7: CIS43LS (20 mg/kg IV) | CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV/SC or 20 mg/kg IV in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 4 | 3 | 4 | View |
| Part B, Group 8: CHMI [CIS43LS (40 mg/kg IV) in Part A] | Part B, Group 8 participants included participants previously enrolled in Part A who received CIS43LS (40 mg/kg IV) in the first part of the study but did not receive CIS43LS in Part B of the study. Group 8 participants were enrolled to complete the controlled human malaria infection (CHMI). Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 2 | 0 | 2 | View |
| Part B, Group 9: CIS43LS (40 mg/kg IV) | CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 1 | 4 | 2 | 4 | View |
| Part B, Group 10: CHMI Controls | Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI) Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 6 | 1 | 6 | View |
| Part C, Group 11: CIS43LS (1 mg/kg IV) | CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 7 | 5 | 7 | View |
| Part C, Group 12: CIS43LS (5 mg/kg IV) | CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 4 | 3 | 4 | View |
| Part C, Group 13: CIS43LS (5 mg/kg SC) | CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 4 | 4 | 4 | View |
| Part C, Group 14: CIS43LS (10 mg/kg IV) | CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 3 | 2 | 3 | View |
| Part C, Group 15: CIS43LS (10 mg/kg SC) | CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain). | 0 | None | 0 | 4 | 4 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Perirectal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Muscle Strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Administration site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Administration site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Lipoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Conjunctivitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Administration site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Administration site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Fibula Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Pain In Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Rotator Cuff Syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Menstruation Irregular | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Upper-Airway Cough Syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Skin Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |