Study: NCT03116698

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 62 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Application site events
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Immune disorders
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Laboratory test abnormalities
Serious: no
Organ System: Investigations
Frequency: 1 affected / 62 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 62 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 62 at risk

Adverse event: Procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 62 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 57 at risk

Adverse event: Laboratory test abnormalities
Serious: no
Organ System: Investigations
Frequency: 1 affected / 57 at risk

Adverse event: Musculoskeletal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 57 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 57 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Subject died due to cardiovascular disease 23 days after the last study drug application, prior to completing end-of-study procedures. The subject was in the DFD-07 Cream, 2.5% BID group. The Investigator determined it to be unrelated to study drug
Frequency: 1 affected / 62 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject passed out and died at home five days after last study drug application. Autopsy was not performed but the cause of death was reported as COPD. The Investigator determined the death to be unrelated to the study drug,
Frequency: 1 affected / 62 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 62 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Application site events
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 62 at risk

Adverse event: Metabolic disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 62 at risk

Adverse event: Musculoskeletal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 62 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 62 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 62 at risk

Adverse event: Respiratory events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 62 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 62 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 57 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Application site events
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Immune disorders
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 57 at risk

Adverse event: Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 57 at risk

Adverse event: Laboratory test abnormalities
Serious: no
Organ System: Investigations
Frequency: 1 affected / 57 at risk

Adverse event: Metabolic disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Musculoskeletal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 57 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Respiratory events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 57 at risk