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 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
NCT ID:
NCT04102020
Description:
None
Frequency Threshold:
5
Time Frame:
All-cause mortality and adverse event tables include events reported from the time of informed consent to the interim cutoff date of 05OCT2022. The median time on follow-up was 446, 687, 389 days for Part 1 VEN400_AZA20, VEN400_AZA36, VEN400_AZA50 and 67.5, 275 days for Part 3 Dose Level 1 (VEN400_CC200), Dose Level 2 (VEN400_CC300), respectively.
Study:
NCT04102020
Study Brief:
A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2 | Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles. Venetoclax: Tablet: Oral Azacitidine: Subcutaneous (SC) or intravenous (IV) injection | 1 | None | 5 | 20 | 20 | 20 | View |
| Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD). Venetoclax: Tablet: Oral Azacitidine: Oral Tablet | 1 | None | 5 | 30 | 29 | 30 | View |
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD. Venetoclax: Tablet: Oral Azacitidine: Oral Tablet | 1 | None | 3 | 16 | 16 | 16 | View |
| Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2 | Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles. Venetoclax: Tablet: Oral Azacitidine: Subcutaneous (SC) or intravenous (IV) injection | 3 | None | 5 | 23 | 21 | 23 | View |
| Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2 | Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles. Venetoclax: Tablet: Oral Azacitidine: Subcutaneous (SC) or intravenous (IV) injection | 5 | None | 7 | 23 | 22 | 23 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| CARDIAC TAMPONADE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.0 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| ANORECTAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| BACILLUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PSEUDOMONAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| EUGLYCAEMIC DIABETIC KETOACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| HAEMORRHAGIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVID-19 PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| TINNITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.0 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| ANAL FISTULA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| APHTHOUS ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| DENTAL CARIES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| FREQUENT BOWEL MOVEMENTS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| GINGIVAL BLEEDING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| GINGIVAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| GINGIVAL SWELLING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| INJECTION SITE REACTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.0 | View |
| HYPERTRANSAMINASAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.0 | View |
| SEASONAL ALLERGY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |
| ASYMPTOMATIC COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| BACTERIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| GINGIVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| HERPES SIMPLEX | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PERIORBITAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PHARYNGOTONSILLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| RESPIRATORY TRACT INFECTION VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| SOFT TISSUE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| TINEA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| LIMB INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| BILIRUBIN CONJUGATED INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| BLOOD LACTATE DEHYDROGENASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| BLOOD UREA INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| DYSLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| HYPERURICAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| HYPOURICAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| ACROCHORDON | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| VULVOVAGINAL DRYNESS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| RHINITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| ASTEATOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| DERMAL CYST | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| MACULE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| NIGHT SWEATS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| PAPULE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| PURPURA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| SKIN EXFOLIATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| SUPERFICIAL VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |