Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:18 PM
Ignite Modification Date: 2025-12-25 @ 2:55 PM
NCT ID: NCT00845650
Description: None
Frequency Threshold: 5
Time Frame: From the time of infusion through Day 90.
Study: NCT00845650
Study Brief: Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AIGIV 3.5 mg/kg (Cohort A) AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. 0 None 1 30 28 30 View
Gamunex 90 mg/kg (Cohort A) Gamunex 90 mg/kg total IgG as a single intravenous infusion. 0 None 0 5 5 5 View
Gamunex 180 mg/kg (Cohort B) Gamunex 180 mg/kg total IgG as a single intravenous infusion. 0 None 1 14 11 14 View
AIGIV 14.0 mg/kg (Cohort C) AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. 0 None 0 29 29 29 View
Gamunex 360 mg/kg (Cohort C) Gamunex 360 mg/kg total IgG as a single intravenous infusion. 0 None 0 16 15 16 View
AIGIV 7.0 mg/kg (Cohort B) AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. 0 None 1 31 29 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intra-uterine death SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders None View
Infusion site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders None View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Bacteria urine SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations None View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations None View
Heart rate decreased SYSTEMATIC_ASSESSMENT Investigations None View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations None View
Nitrite urine SYSTEMATIC_ASSESSMENT Investigations None View
Protein urine SYSTEMATIC_ASSESSMENT Investigations None View
Respiratory rate increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View