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 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
NCT ID:
NCT00035932
Description:
None
Frequency Threshold:
5
Time Frame:
The AE data below represents data from start of study in November 2001 through the last locked database of the study, 18 November 2009.
Study:
NCT00035932
Study Brief:
Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With 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 |
|---|---|---|---|---|---|---|---|---|
| ATV400/SQV | ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | None | None | 22 | 110 | 95 | 110 | View |
| LPV/RTV | lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | None | None | 19 | 118 | 104 | 118 | View |
| ATV300/RTV | atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | None | None | 22 | 119 | 101 | 119 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| GLAUCOMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| PERICARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CARDIAC TAMPONADE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ANEURYSM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| PELVIC VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| DRUG ABUSE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| ALCOHOL ABUSE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| DRUG DEPENDENCE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| MAJOR DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| SUICIDAL IDEATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| HEPATIC CIRRHOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CONVULSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| TENSION HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CAROTID ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| DEPRESSED LEVEL OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| HAEMATEMESIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DIARRHOEA HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| LOWER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ABSCESS LIMB | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ANAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| NEUROSYPHILIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CRYPTOCOCCOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| LOBAR PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PYELONEPHRITIS ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| GASTROENTERITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| MENINGITIS TUBERCULOUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| OESOPHAGEAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CLOSTRIDIUM DIFFICILE COLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| POSTOPERATIVE WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| RENAL TUBULAR ACIDOSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| HOSPITALISATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 12.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| HYPERLACTACIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| METABOLIC ACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| PROSTATITIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| OVARIAN CYST | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| VAGINAL PROLAPSE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| MENSTRUATION IRREGULAR | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| HEAD INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| FOOT FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| SPINAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| LOWER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| OSTEONECROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| RESPIRATORY DISTRESS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| CYST | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| LYMPHOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| ANAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| NON-HODGKIN'S LYMPHOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| SQUAMOUS CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| OCULAR ICTERUS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| LIPASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| BLOOD TRIGLYCERIDES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| JAUNDICE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| LIPOATROPHY | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| LIPODYSTROPHY ACQUIRED | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |