Adverse Events Module

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 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:19 PM
NCT ID: NCT03642132
Description: Both non serious AEs and SAEs were recorded on the case report form.
Frequency Threshold: 5
Time Frame: All-Cause mortality: collected from the signing of Informed Consent (IC) up to 90 calendar days after the last administration of the investigational product (maximum of approximately 3.5 years). Serious and non-serious adverse events (AEs) were collected from the time of the first dose of study treatment through up to 30 days after last dose of study treatment or the start of new anti-cancer drug therapy minus 1 day (maximum of approximately 3.5 years).
Study: NCT03642132
Study Brief: Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chemotherapy +Avelumab -> Avelumab + Talazoparib In chemotherapy period, participants received paclitaxel 175 mg/m\^2 intravenously(IV) over 3 hours followed by carboplatin area under the concentration (AUC) 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles along with avelumab 800 mg administered IV on Day 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received avelumab 800 mg administered IV on Days 1, 15 and 29 of each 6-week cycle in combination with talazoparib 0.75 mg self-administered orally once per day. A cycle was defined as 3 weeks (21 days) in the chemotherapy period and 6 weeks (42 days) in the maintenance period, respectively. 1 None 9 29 29 29 View
Chemotherapy -> Talazoparib In chemotherapy period, participants received paclitaxel 175 mg/m\^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. 0 None 4 13 13 13 View
Chemotherapy + Bevacizumab -> Bevacizumab In chemotherapy period, participants received paclitaxel 175 mg/m\^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. 2 None 15 34 34 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Large intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Incarcerated hernia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v24.1 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v24.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Splenomegaly NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v24.1 View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v24.1 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v24.1 View
Visual field defect NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v24.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Temperature intolerance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v24.1 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v24.1 View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v24.1 View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Vulvovaginal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Blood corticotrophin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Vitamin D deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Cognitive disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Taste disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v24.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v24.1 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v24.1 View
Vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.1 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.1 View
Vulvovaginal burning sensation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.1 View
Vulvovaginal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.1 View
Vulvovaginal pruritus NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Upper-airway cough syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View