Trial Outcomes & Findings for Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus (NCT NCT00504348)
NCT ID: NCT00504348
Last Updated: 2020-03-24
Results Overview
Overall survival (OS) was calculated from the day on which the protocol treatment was started until death due to any cause. Participants still alive were censored at the date they were last known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
25 participants
Primary outcome timeframe
52 weeks
Results posted on
2020-03-24
Participant Flow
Participant milestones
| Measure |
Prospective Investigation Group
Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.
Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Prospective Investigation Group
Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.
Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
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|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus
Baseline characteristics by cohort
| Measure |
Prospective Investigation Group
n=25 Participants
Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.
Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
|
|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksOverall survival (OS) was calculated from the day on which the protocol treatment was started until death due to any cause. Participants still alive were censored at the date they were last known to be alive.
Outcome measures
| Measure |
Prospective Investigation Group
n=25 Participants
Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.
Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
|
|---|---|
|
Overall Survival
|
88.0 percentage of participants
Interval 67.3 to 96.0
|
SECONDARY outcome
Timeframe: 52 weeksPatients were considered to have reached the progression if they died, or if they met all the following criteria; (1) ≥10% decline from baseline FVC or ≥15mmHg increase in baseline resting P(A-a)O2, (2) a worsening of interstitial pneumonitis findings by chest CT compared to the most recent study, confirmed by a radiologist, and (3) exclusion of pneumocystis pneumonia, cytomegalovirus pneumonia, and other pulmonary infection on clinical ground.
Outcome measures
| Measure |
Prospective Investigation Group
n=25 Participants
Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.
Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
|
|---|---|
|
Progression-free Survival
|
76.4 percentage of participants
Interval 51.8 to 89.5
|
Adverse Events
Prospective Investigation Group
Serious events: 11 serious events
Other events: 25 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Prospective Investigation Group
n=25 participants at risk
Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.
Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
24.0%
6/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
zoster
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Infections and infestations
Nocardiosis
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cytomegalovirus pneumonitis
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumocystis jiroveci pneumonia
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Eye disorders
Cataract
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Hepatobiliary disorders
Liver cirrhosis
|
4.0%
1/25 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
Other adverse events
| Measure |
Prospective Investigation Group
n=25 participants at risk
Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be continued for the first 28 days after which be subsequently tapered according to a predefined guideline. Up to two courses of pulse intravenous glucocorticoid therapy are allowed during that period.
Tacrolimus: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
24.0%
6/25 • Number of events 8 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Infections and infestations
Zoster
|
16.0%
4/25 • Number of events 5 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Infections and infestations
Bronchitis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Infections and infestations
Cystitis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Infections and infestations
Gastroenteritis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Infections and infestations
Onychomycosis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Infections and infestations
Oral candidiasis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Infections and infestations
Pharyngeal candidiasis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
3/25 • Number of events 3 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Cushingoid appearance
|
20.0%
5/25 • Number of events 5 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Diabetes mellitus
|
28.0%
7/25 • Number of events 8 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Dyslipidemia
|
28.0%
7/25 • Number of events 7 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Glucose intolerance
|
24.0%
6/25 • Number of events 6 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Hyperkalemia
|
16.0%
4/25 • Number of events 4 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Hypoglycemia
|
12.0%
3/25 • Number of events 3 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Dehydration
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Hypomagnesemia
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Hypophosphatemia
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Endocrine disorders
Hyperlipidemia
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Psychiatric disorders
Insomnia
|
20.0%
5/25 • Number of events 6 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Nervous system disorders
Tremor
|
28.0%
7/25 • Number of events 7 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Nervous system disorders
Hypesthesia
|
12.0%
3/25 • Number of events 5 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Eye disorders
Cataract
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Eye disorders
Conjunctival hemorrhage
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Eye disorders
Conjunctivitis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Cardiac disorders
Ventricular extrasystole
|
12.0%
3/25 • Number of events 3 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Vascular disorders
Hypertension
|
24.0%
6/25 • Number of events 8 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Vascular disorders
Hypotension
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
36.0%
9/25 • Number of events 10 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
36.0%
9/25 • Number of events 9 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
6/25 • Number of events 7 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
5/25 • Number of events 5 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • Number of events 3 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Upper abdominal pain
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Cheilitis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Colon polyp
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Erosive gastritis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Hepatobiliary disorders
Fatty liver
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Hepatobiliary disorders
Liver disorder
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.0%
4/25 • Number of events 4 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous hemorrhage
|
16.0%
4/25 • Number of events 5 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
12.0%
3/25 • Number of events 3 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
12.0%
3/25 • Number of events 3 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
General disorders
Peripheral edema
|
16.0%
4/25 • Number of events 4 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Asteatotic eczema
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
General disorders
Feeling unwell
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
16.0%
4/25 • Number of events 4 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
8.0%
2/25 • Number of events 2 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
|
Renal and urinary disorders
Renal dysfunction
|
12.0%
3/25 • Number of events 3 • All adverse events observed between the first dose and 28 days after the last dose of tacrolimus.
Testing for safety was performed at set intervals and consisted of vital signs and physical examinations, laboratory testing, and evaluation for adverse events and serious adverse events.
|
Additional Information
Kazuki Takada, M.D.
Tokyo Medical and Dental University
Phone: 81-3-3813-6111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place