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 @ 11:02 PM
Ignite Modification Date: 2025-12-25 @ 8:32 PM
NCT ID: NCT00448669
Description: Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Frequency Threshold: 0
Time Frame: Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years.
Study: NCT00448669
Study Brief: Botswana TDF/FTC Oral HIV Prophylaxis Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo, Condoms, Risk Counseling Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC None None 44 608 536 608 View
TDF-FTC, Condoms, Risk Counseling Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC. None None 42 611 557 611 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Injury, non-fatal NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Wound NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICD9-CM View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICD9-CM View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICD9-CM View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Elevated ALT NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders ICD9-CM View
Hyperamylasemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders ICD9-CM View
Hyperchloremia NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Elevated creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICD9-CM View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders ICD9-CM View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Tonsillitis, acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations ICD9-CM View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Balanitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ICD9-CM View
Breast Abnormalities NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders ICD9-CM View
Chlamydia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations ICD9-CM View
Conjuctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders ICD9-CM View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Contusion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD9-CM View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Dermatomycosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Dermatophytosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Disturbance of Skin Sensation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders ICD9-CM View
Dysmenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICD9-CM View
Edema, limb NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Epistaxis NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Gastroesophageal Reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Generalized Pain NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Genital Herpes NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Gonorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders ICD9-CM View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders ICD9-CM View
Injury, Nonfatal NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ICD9-CM View
Leukorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Oral Disease, Gingiva NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Oral Disease, Teeth NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Pain, Ear NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders ICD9-CM View
Pain, Abdominal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Pain, Acute Musculoskeletal NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Pain, Back NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Pain, Genital NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Pain, Joint NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Pain, Limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD9-CM View
Painful Eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders ICD9-CM View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders ICD9-CM View
Pelvic Inflammatory Disease NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Pharyngitis, Acute NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Polyphagia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders ICD9-CM View
Pruritus, Genital NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Pruritus, Unspecified NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Rash, Unspecified NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Rhinitis NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Shortness of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD9-CM View
Sore Ulcer, Genital NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Sore Ulcer, Oral Cavity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Tonsilitis, Acute NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
Trichomoniasis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Urethral Discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICD9-CM View
Vaginal Candidiasis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Wound NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Blood Urea Nitrogen NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICD9-CM View
Phosphate NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ICD9-CM View
Amylase, Serum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Bilirubin, total NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ICD9-CM View
Bilirubin, direct NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
Sodium NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ICD9-CM View
Potassium NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ICD9-CM View
Bicarbonate NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ICD9-CM View
Chloride NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ICD9-CM View
Abnormal Menses NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders ICD9-CM View
Abscess NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICD9-CM View
Allergy, unspecified NON_SYSTEMATIC_ASSESSMENT General disorders ICD9-CM View
AST/SGOT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View
ALT/SGPT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD9-CM View