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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:44 PM
NCT ID: NCT03004469
Description: The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Frequency Threshold: 0
Time Frame: From the start of the IMP up to 28 weeks
Study: NCT03004469
Study Brief: Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
P-3074 + Finasteride Placebo Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks. 0 None 4 181 74 181 View
P-3074 Vehicle + Finasteride Placebo Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks. 0 None 5 181 73 181 View
Oral Finasteride + P-3074 Vehicle Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks. 0 None 1 84 40 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Exposure via father NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Skull fractured base NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Anogenital warts NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Nasal septum deviation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumothorax spontaneous NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Libido decreased NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Loss of libido NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Stress NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Balanoposthitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Sinus arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Blepharitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anal pruritus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Inguinal hernia perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Application site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Hepatocellular injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hypertransaminasaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Dust allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Anorectal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Epididymitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastritis helminthic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastrointestinal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Infected bite NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Otitis externa NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Periodontitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pertussis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pulpitis dental NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rash pustular NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Testicular abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Ligament rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Meniscus injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Skin injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin unconjugated increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood pressure systolic increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood uric acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Crystal urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Red blood cells urine positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Stress echocardiogram abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
White blood cells urine positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Vitamin B12 deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Vitamin D deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Anogenital warts NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cervicogenic headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Head discomfort NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Burnout syndrome NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Initial insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Sexual dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Catarrh NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Nasal pruritus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dermal cyst NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Diffuse alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Papule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritus generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash vesicular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Sebaceous gland disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin burning sensation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin plaque NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Vitiligo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
High risk sexual behaviour NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 19.0 View
Stress at work NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 19.0 View