Trial Outcomes & Findings for Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma (NCT NCT02296164)

Last Updated: 2020-03-04

Results Overview

The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment.

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

12 Months

Results posted on

2020-03-04

Participant Flow

The study registered 301 consecutive adult patients (Only registered/not enrolled:1; Enrolled: 300) diagnosed with MF-CTCL and being treated with Valchlor, regardless of other MF-CTCL therapies received before or at enrollment. All patients were enrolled from 46 participating centers/clinics in university-affiliated or community hospitals in the US

All consecutive MF-CTCL patients being treated with Valchlor were invited to enroll in this study. Two patients were not eligible as they were not on Valchlor at time of study start

Participant milestones

Participant milestones
Measure	MF-CTCL Patients Receiving Valchlor Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient-completed questionnaires for symptoms and QOL, there were no specific or mandated clinical assessments performed, and patients did not receive experimental intervention or treatment as a consequence of their participation in this study. Continuation in the study was not contingent on continuation of Valchlor. Valchlor: Valchlor gel 0.016%
Overall Study STARTED	298
Overall Study COMPLETED	188
Overall Study NOT COMPLETED	110

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MF-CTCL Patients Receiving Valchlor n=298 Participants Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient completed questionnaires for symptoms and Quality Of Life. Valchlor: Valchlor gel 0.016%
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	162 Participants n=5 Participants
Age, Categorical >=65 years	136 Participants n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants
Sex: Female, Male Male	179 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=5 Participants
Race/Ethnicity, Customized African American	45 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	29 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/other Pacific Islander	6 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or ≥2 races/ethnicities	2 Participants n=5 Participants
Race/Ethnicity, Customized Not Disclosed	203 Participants n=5 Participants
Region of Enrollment United States	298 Participants n=5 Participants
diagnosed with MF-CTCL and being treated with Valchlor.	298 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment.

Outcome measures

Outcome measures
Measure	MF-CTCL Patients Receiving Valchlor n=298 Participants Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient completed questionnaires for symptoms and Quality Of Life. Valchlor: Valchlor gel 0.016%
Treatment Responders Using Body Surface Area (BSA) at 12 Months	44 Participants

Adverse Events

MF-CTCL Patients Receiving Valchlor

Serious events: 23 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MF-CTCL Patients Receiving Valchlor n=298 participants at risk Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient completed questionnaires for symptoms and Quality Of Life. Valchlor: Valchlor gel 0.016%
Skin and subcutaneous tissue disorders Skin ulcer	0.67% 2/298 • Number of events 2 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Gastrointestinal disorders Abdominal pain	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
General disorders Asthenia	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
General disorders Death	0.67% 2/298 • Number of events 2 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
General disorders Fatigue	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
General disorders Multi-organ failure	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
General disorders Non-cardiac chest pain	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
General disorders Pyrexia	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Bacteraemia	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Bronchitis	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Clostridium difficile colitis	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Device related sepsis	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Endocarditis bacterial	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Osteomyelitis	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Pneumonia	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Sepsis	1.0% 3/298 • Number of events 3 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Infections and infestations Staphylococcal bacteraemia	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Injury, poisoning and procedural complications Fall	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Injury, poisoning and procedural complications Pulmonary contusion	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Injury, poisoning and procedural complications Rib fracture	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Injury, poisoning and procedural complications Wrist fracture	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Investigations Liver function test abnormal	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Metabolism and nutrition disorders Decreased appetite	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Metabolism and nutrition disorders Failure to thrive	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large cell lymphoma T- and null-cell types	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis fungoides	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer with HLT skin neoplasm malignant and unspecified (exc. Melanoma)	0.67% 2/298 • Number of events 2 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Nervous system disorders Cerebrovascular accident	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Nervous system disorders Depressed level of consciousness	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Renal and urinary disorders Renal failure acute	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Surgical and medical procedures Packed red blood cell transfusion	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Vascular disorders Aortic aneurysm	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Vascular disorders Deep vein thrombosis	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Vascular disorders Haematoma	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Vascular disorders Jugular vein thrombosis	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Vascular disorders Venous thrombosis limb	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Blood and lymphatic system disorders Anaemia	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Cardiac disorders Atrial fibrillation	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Cardiac disorders Bradycardia	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Cardiac disorders Cardiac arrest	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Cardiac disorders Cardiac failure congestive	0.34% 1/298 • Number of events 1 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.

Other adverse events

Other adverse events
Measure	MF-CTCL Patients Receiving Valchlor n=298 participants at risk Patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. With the exception of protocol-required patient completed questionnaires for symptoms and Quality Of Life. Valchlor: Valchlor gel 0.016%
Skin and subcutaneous tissue disorders Dermatitis	12.8% 38/298 • Number of events 38 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Skin and subcutaneous tissue disorders Erythema	5.0% 15/298 • Number of events 15 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Skin and subcutaneous tissue disorders Pruritus	9.7% 29/298 • Number of events 29 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
Skin and subcutaneous tissue disorders Skin irritation	7.4% 22/298 • Number of events 22 • The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years). The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death. Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis). Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.

Additional Information

Bill Bailey

Helsinn Therapeutics (U.S.), Inc.

Phone: +1 732 603 2848

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place