Adverse Events Module

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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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT03989102
Description: None
Frequency Threshold: 1
Time Frame: Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4
Study: NCT03989102
Study Brief: Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 3 Participants received 3 doses of saline injection via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection. 0 None 0 100 43 100 View
Arm 1 Participants received 3 doses of PfSPZ Vaccine (9 x10\^5) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection. 0 None 0 100 51 100 View
Arm 2 Participants received 3 doses of PfSPZ Vaccine (1.8 x10\^6) via direct venous inoculation (DVI) at 1, 8, 29 days. Oral antimalarial treatment with artemether/lumefantrine (AL) was given 2 weeks prior to 1st and 3rd injection. 1 None 0 100 43 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site edema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pruritus (localized) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritis (generalized) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vessel puncture site erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders None View