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 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
NCT ID:
NCT00102960
Description:
Only System Organ Class and Higher Level Terms are reported for 377 participants (ART-Def 125, ART-40W 126 and ART-96W 126)
Frequency Threshold:
5
Time Frame:
4.8 years, the study duration
Study:
NCT00102960
Study Brief:
Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ART-Deferred | For participants with a CD4% of at least 25%, ART deferred until necessary. Once ART therapy was initiated, it was taken continuously. Zidovudine: First Line Regimen: Given twice daily at a dose of 240 mg/m\^2 of body surface area. Dose was adjusted by age as the children grew older. Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight. Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m\^2 Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol. Didanosine: Second Line Regimen: Either 100 mg/m\^2 or 120 mg/m\^2 taken orally twice daily. Dosage depends on age. Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight. Nevirapine: Second Line Regimen: 150 - 200 mg/m\^2 taken orally twice daily. | 23 | None | 79 | 125 | 123 | 125 | View |
| Early ART up to 40 Weeks | For participants with a CD4% of at least 25%, receive 40 weeks of ART until first birthday Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older. Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight. Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m\^2 Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol. Didanosine: Second Line Regimen: Either 100 mg/m\^2 or 120 mg/m\^2 taken orally twice daily. Dosage depends on age. Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight. Nevirapine: Second Line Regimen: 150 - 200 mg/m\^2 taken orally twice daily. | 11 | None | 60 | 126 | 122 | 126 | View |
| Early ART up to 96 Weeks | For participants with a CD4% of at least 25%, receive ART for 96 weeks until second birthday Zidovudine: First Line Regimen: 10 mg/mL taken orally twice per day. Dose was adjusted by age as the children grew older. Lamivudine: First Line Regimen: 4 mg/kg taken orally twice daily Lopinavir/Ritonavir: First Line Regimen: taken orally twice daily. Dosage depends on age and weight. Ritonavir: First Line Regimen taken orally twice a day. Started at 250 mg/m\^2 Abacavir sulfate: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol. Didanosine: Second Line Regimen: Either 100 mg/m\^2 or 120 mg/m\^2 taken orally twice daily. Dosage depends on age. Efavirenz: Second Line Regimen: taken orally once daily. Dosage depends on weight. Nevirapine: Second Line Regimen: 150 - 200 mg/m\^2 taken orally twice daily. | 11 | None | 53 | 126 | 125 | 126 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Kwashiorkor | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Febrile seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Focal seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Generalised tonic-clonic seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Pneumococcal meningitis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Acute renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| Rectovaginal fistula | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 10.1 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Aspiration pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Cerebral palsy | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 10.1 | View |
| Hearing loss unilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 10.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Accidental death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Apparent death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Unknown cause of death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Hepatomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| Liver failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| HIV wasting syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 10.1 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Chickenpox | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Croup | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Cytomegalovirus encephalitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Cytomegalovirus hepatitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Esophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Laryngotracheo bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Miliary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Oesophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Osteomyelitis chronic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pharyngitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pneumococcal pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pneumococcal Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pneumocystis carinii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Septicaemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| TB | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Tuberculous bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Viral meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Burns | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Forearm fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Fracture femur | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Skull fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| AST increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Gamma GT increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Hepatomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| AIDS encephalopathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Candida nappy rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Molluscum Contagiosum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Mucocutaneous Herpes Simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Oral Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Persistent Generalised Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Scabies | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| TB | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Tinea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Tonsilitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Varicella Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Gamma GT Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Nappy rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| ALT Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |