Trial Outcomes & Findings for Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide (NCT NCT02966301)
NCT ID: NCT02966301
Last Updated: 2022-05-09
Results Overview
Clinical response will be evaluated based on the Working Group Report 2015, published by the National Institute of Health Consensus. Response definition is as follows: * Complete remission (CR) is defined as complete disappearance of any sign of chronic GvHD. * Partial remission (PR) is defined as a significant improvement as defined by the organ or site specific measurement scale without progression in any other organ or site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
six months
Results posted on
2022-05-09
Participant Flow
Participant milestones
| Measure |
Arsenic Trioxide Injectable Solution
Single arm : Arsenic trioxide Injectable Solution
Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
The study duration will be 2 years (12 months recruitment + 12 months follow-up).
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
Full Analysis Set (FAS)
|
20
|
|
Overall Study
Safety Analysis (SA)
|
21
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Arsenic Trioxide Injectable Solution
Single arm : Arsenic trioxide Injectable Solution
Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
The study duration will be 2 years (12 months recruitment + 12 months follow-up).
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arsenic Trioxide
n=21 Participants
Single arm : Arsenic trioxide
Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8-10 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
The study duration was 3.5 years (36 months recruitment + 12 months follow-up).
|
|---|---|
|
Age, Continuous
|
62 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
21 participants
n=21 Participants
|
|
Diagnosis of chronic GvHD requiring systemic immunosuppressive therapy confirmed,
|
21 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: six monthsPopulation: All patients who entered the study, completed their first cycle of ATO and for whom the response at Week 6 after diagnosis of chronic GvHD has been evaluated.
Clinical response will be evaluated based on the Working Group Report 2015, published by the National Institute of Health Consensus. Response definition is as follows: * Complete remission (CR) is defined as complete disappearance of any sign of chronic GvHD. * Partial remission (PR) is defined as a significant improvement as defined by the organ or site specific measurement scale without progression in any other organ or site.
Outcome measures
| Measure |
Interventional
n=20 Participants
Single arm : Arsenic trioxide Injectable Solution
Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
The study duration will be 2 years (12 months recruitment + 12 months follow-up).
|
|---|---|
|
Number of Participants With Complete or Partial Remission of Chronic Graft Versus Host Disease After a First Line Treatment With Arsenic Trioxide
|
15 Participants
|
SECONDARY outcome
Timeframe: Average dose of Prednisone at 6 months after the first infusion of ATOPopulation: All patients who entered the study, completed their first cycle of ATO and for whom the response at Week 6 after diagnosis of chronic GvHD has been evaluated.
Average dose in mg/kg/day of prednisone or prednisone equivalent
Outcome measures
| Measure |
Interventional
n=20 Participants
Single arm : Arsenic trioxide Injectable Solution
Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
The study duration will be 2 years (12 months recruitment + 12 months follow-up).
|
|---|---|
|
Average Dose of Corticosteroids
|
0.22 mg/kg/day
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 6 months after first ATO infusionPopulation: FAS
Treatment failure were defined by: * Initiation of a new systemic treatment for chronic GvHD; * Recurrent or progressive malignancy; * Death
Outcome measures
| Measure |
Interventional
n=20 Participants
Single arm : Arsenic trioxide Injectable Solution
Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
The study duration will be 2 years (12 months recruitment + 12 months follow-up).
|
|---|---|
|
Failure Free Survival
|
90 percentage of participants
Interval 65.6 to 97.4
|
SECONDARY outcome
Timeframe: 12 months after the first infusion of ATO for each patientPopulation: Safety Analysis Population
Tolerability and safety of ATO in combination with Prednisone, with or without Ciclosporine, in patients with chronic GvHD after allo-SCT. Adverse events follow-up for all patients throughout the study
Outcome measures
| Measure |
Interventional
n=21 Participants
Single arm : Arsenic trioxide Injectable Solution
Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
The study duration will be 2 years (12 months recruitment + 12 months follow-up).
|
|---|---|
|
Number of Adverse Events
|
197 number of events
|
SECONDARY outcome
Timeframe: 12 months after first ATO infusionPopulation: FAS
Non-Relapse Mortality (NRM) of infectious and non-infectious origin
Outcome measures
| Measure |
Interventional
n=20 Participants
Single arm : Arsenic trioxide Injectable Solution
Arsenic Trioxide Injectable Solution: Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
The study duration will be 2 years (12 months recruitment + 12 months follow-up).
|
|---|---|
|
Cumulative Incidence for Non-relapse Mortality (NRM)
|
5 percentage of participants
Interval 0.3 to 21.1
|
Adverse Events
Arsenic Trioxide Infusion
Serious events: 21 serious events
Other events: 21 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arsenic Trioxide Infusion
n=21 participants at risk
Single arm : Arsenic trioxide Injectable Solution
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection viral
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Nervous system disorders
Encephalopathy
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Nervous system disorders
Epilepsy
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Oedema peripheral
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Hepatobiliary disorders
Hepatitis acute
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Hepatobiliary disorders
Hepatotoxicity
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Septic shock
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Urinary tract infection
|
14.3%
3/21 • Number of events 3 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Genital herpes
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Oropharyngeal candidiasis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Escherichia pyelonephritis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
Other adverse events
| Measure |
Arsenic Trioxide Infusion
n=21 participants at risk
Single arm : Arsenic trioxide Injectable Solution
|
|---|---|
|
General disorders
Oedema peripheral
|
33.3%
7/21 • Number of events 8 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Vascular disorders
Hyperaemia
|
4.8%
1/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Vascular disorders
Thrombosis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Vascular disorders
Venous thrombosis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Immune system disorders
Drug hypersensitivity
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Immune system disorders
Hypogammaglobulinaemia
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Asthenia
|
14.3%
3/21 • Number of events 3 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Chest pain
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Cyst
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Face oedema
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Influenza like illness
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Medical device pain
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Mucosal inflammation
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Pain
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
General disorders
Pyrexia
|
23.8%
5/21 • Number of events 7 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Psychiatric disorders
Insomnia
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Psychiatric disorders
Irritability
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Psychiatric disorders
Sleep disorder
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Injury, poisoning and procedural complications
Scar
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Investigations
Cardiac murmur
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Investigations
CD4 lymphocytes decreased
|
4.8%
1/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Investigations
Electrocardiogram QT prolonged
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Cardiac disorders
Angina pectoris
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Cardiac disorders
Atrial fibrillation
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
9/21 • Number of events 10 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
3/21 • Number of events 3 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Blood and lymphatic system disorders
Anaemia
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Nervous system disorders
Dysgeusia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Nervous system disorders
Paraesthesia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Nervous system disorders
Peroneal nerve palsy
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Nervous system disorders
Seizure
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Eye disorders
Dry eye
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Eye disorders
Keratitis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Eye disorders
Ocular discomfort
|
4.8%
1/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Eye disorders
Vision blurred
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Eye disorders
Visual acuity reduced
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
3/21 • Number of events 4 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Diarrhoea
|
38.1%
8/21 • Number of events 10 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Odynophagia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Hepatobiliary disorders
Hepatocellular injury
|
9.5%
2/21 • Number of events 4 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
3/21 • Number of events 3 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Skin and subcutaneous tissue disorders
Lichenification
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • Number of events 3 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Endocrine disorders
Cushing's syndrome
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Metabolism and nutrition disorders
Fluid retention
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.0%
4/21 • Number of events 5 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Metabolism and nutrition disorders
Malnutrition
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Bronchitis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Campylobacter infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Conjunctivitis
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Cytomegalovirus infection
|
9.5%
2/21 • Number of events 3 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Device related infection
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Epstein-Barr virus infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Escherichia urinary tract infection
|
9.5%
2/21 • Number of events 2 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Fungal infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Genital herpes
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Genital infection fungal
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Klebsiella infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Oral herpes
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Pseudomonal bacteraemia
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Respiratory syncytial virus infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Rhinovirus infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Staphylococcal infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Staphylococcal sepsis
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • Number of events 7 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Viral infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
4.8%
1/21 • Number of events 1 • For each patient the specific period over which data on adverse events were collected is 1 year after inclusion in the clinical study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place