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 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:07 AM
NCT ID: NCT01228318
Description: The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
Frequency Threshold: 0
Time Frame: Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist.
Study: NCT01228318
Study Brief: Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zoledronic Acid Participants in this arm received a 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel. 0 None 7 34 34 34 View
Placebo Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel. 0 None 6 29 28 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to pancreatitis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hospitalization due to abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization due to community acquired pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization due to neurosyphilis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization due to gastro esphageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Psychiatric hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization due to brochitis and otitis externa NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization related to Graves' Disease NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hospitalization due to sub-acute cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal/sinus drainage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Night sweats SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Numbness/tingling SYSTEMATIC_ASSESSMENT General disorders None View
Rash (head, shoulder, feet) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decreased libido SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Myalgias SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgias SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flulike symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT General disorders None View
Loss of memory SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Motor weakness SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vein distended SYSTEMATIC_ASSESSMENT Vascular disorders None View
Odynophagia SYSTEMATIC_ASSESSMENT General disorders None View
Kaposi sarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tooth ache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Generalized muscle pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Left eye twitching NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain from shingles NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bloody stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Groin pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Muscle cramps (hands, feet, legs) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intermittent nose bleed NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in right ear NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Foot pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Throat pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal tenderness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ankle tenderness/pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arm pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bitter mouth taste NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bladder spasms NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Boil left buttock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bone pain in left hand NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bruising easily NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bump inside mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Burning in chest with excertion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dark spots NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dark urine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Decreased hearing/ear stopped up NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Easily distracted NON_SYSTEMATIC_ASSESSMENT General disorders None View
Entire body heat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Itchy/watery eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Facial acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Frequent urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
General body aches NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hair thinning NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hearing voices NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Herpes outbreak NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hotflashes NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Knee swollen NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower extremity edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lower left leg pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left sided weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Numbness (hands, legs, body) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Loss of balance NON_SYSTEMATIC_ASSESSMENT General disorders None View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain/stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in right knee NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash left forehead NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Right shoulder discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right facial swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Right side weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Right wrist pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Salivation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Scalp pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seeing spots NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Stomach feels tight NON_SYSTEMATIC_ASSESSMENT General disorders None View
Testicular pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal itching NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Welts when skin scratched NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oral pain SYSTEMATIC_ASSESSMENT General disorders None View
Photophobia SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bone pain SYSTEMATIC_ASSESSMENT General disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View