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: 2025-12-24 @ 5:22 PM
Ignite Modification Date: 2025-12-24 @ 5:22 PM
NCT ID: NCT03952650
Description: None
Frequency Threshold: 0
Time Frame: One month for pilot phase; eight months for main phase; seven months for booster phase
Study: NCT03952650
Study Brief: Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1a - Pilot/Safety: Dosing Interval on Days: 1 Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ 0 None 0 4 1 4 View
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57. 1 None 1 90 88 90 View
2a - Pilot/Safety: Dosing Interval on Days: 1 Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ 0 None 0 4 1 4 View
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57. 0 None 0 60 59 60 View
3a - Pilot/Safety: Dosing Interval on Days: 1 Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with chloroquine 2 days prior \& 5 days post PfSPZ 0 None 0 4 2 4 View
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57 Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57. 0 None 1 54 51 54 View
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57 Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57. 0 None 0 36 36 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accident at home SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysentery SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye burns SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Forearm fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genital infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genitourinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection site oedema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intercostal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Malaria SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Parasitic gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyoderma SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Strangulated umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Systolic hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Typhoid fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders None View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View