Trial Outcomes & Findings for A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) (NCT NCT01077544)
NCT ID: NCT01077544
Last Updated: 2020-12-29
Results Overview
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
COMPLETED
PHASE1
15 participants
Cycle 1 Day 1
2020-12-29
Participant Flow
Participant milestones
| Measure |
Group 1
1 year to \< 10 years pediatric patients
|
Group 2
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Group 1
1 year to \< 10 years pediatric patients
|
Group 2
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Overall Study
New Cancer Therapy
|
3
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Disease Progression
|
0
|
1
|
Baseline Characteristics
A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
Baseline characteristics by cohort
| Measure |
Group 1
n=8 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=7 Participants
\>= 10 years to \<18 years pediatric patients
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.8 Years
STANDARD_DEVIATION 1.16 • n=5 Participants
|
13.7 Years
STANDARD_DEVIATION 2.81 • n=7 Participants
|
10.0 Years
STANDARD_DEVIATION 4.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Weight
|
24.60 kg
STANDARD_DEVIATION 4.739 • n=5 Participants
|
48.89 kg
STANDARD_DEVIATION 17.533 • n=7 Participants
|
35.93 kg
STANDARD_DEVIATION 17.328 • n=5 Participants
|
|
Height
|
119.9 cm
STANDARD_DEVIATION 7.49 • n=5 Participants
|
158.0 cm
STANDARD_DEVIATION 16.32 • n=7 Participants
|
137.7 cm
STANDARD_DEVIATION 23.02 • n=5 Participants
|
|
Body Mass Index (BMI)
|
16.962 kg/m^2
STANDARD_DEVIATION 1.7654 • n=5 Participants
|
18.944 kg/m^2
STANDARD_DEVIATION 3.4563 • n=7 Participants
|
17.887 kg/m^2
STANDARD_DEVIATION 2.7795 • n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1Population: Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
Outcome measures
| Measure |
Group 1
n=7 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=7 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Summary of Nilotinib Non-compartmental PK Parameters: Cmax
|
405.111 ng/mL
Geometric Coefficient of Variation 42.5
|
402.715 ng/mL
Geometric Coefficient of Variation 35.2
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1Population: Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
Outcome measures
| Measure |
Group 1
n=7 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=7 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Summary of Nilotinib Non-compartmental PK Parameters: Tmax
|
2.000 h
Full Range 163.1050 • Interval 1.02 to 7.08
|
3.000 h
Full Range 140.8314 • Interval 2.0 to 7.88
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1Population: Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
Outcome measures
| Measure |
Group 1
n=7 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=7 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h)
|
4160.969 ng*h/mL
Geometric Coefficient of Variation 38.5
|
5707.368 ng*h/mL
Geometric Coefficient of Variation 51.2
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1Population: Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.
Outcome measures
| Measure |
Group 1
n=7 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=7 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h
|
2795.782 ng*h/mL
Geometric Coefficient of Variation 35.7
|
3393.296 ng*h/mL
Geometric Coefficient of Variation 30.4
|
PRIMARY outcome
Timeframe: Cycle 1 Day 8 - Cycle 1 Day 28Population: Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses
Outcome measures
| Measure |
Group 1
n=7 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=7 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Summary of Nilotinib Steady-state PK Parameters: AUCss
|
15129.182 ng*h/mL
Geometric Coefficient of Variation 38.0
|
14383.076 ng*h/mL
Geometric Coefficient of Variation 33.6
|
PRIMARY outcome
Timeframe: Cycle 1 Day 8 - Cycle 1 day 28Population: Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses
Outcome measures
| Measure |
Group 1
n=7 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=7 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted)
|
15.356 L/h/m^2)
Geometric Coefficient of Variation 38.7
|
15.922 L/h/m^2)
Geometric Coefficient of Variation 37.0
|
PRIMARY outcome
Timeframe: Cycle 1 Day 8 - Cycle 1 Day 28Population: Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose.
Outcome measures
| Measure |
Group 1
n=7 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=7 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Summary of Nilotinib Steady-state PK Parameters: Cmin
|
804.791 ng/mL
Geometric Coefficient of Variation 33.7
|
1072.850 ng/mL
Geometric Coefficient of Variation 20.5
|
SECONDARY outcome
Timeframe: minimum of 12 cycles (28 days per cycle)Population: Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count \< 10 × 109/L; platelet \< 450 × 109/L; basophils \< 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes \< 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.
Outcome measures
| Measure |
Group 1
n=5 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=6 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)
Yes
|
5 Participants
|
5 Participants
|
|
Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)
No
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: minimum of 12 cycles (28 days per cycle)Population: FAS consist of all patients (pts) who passed screening \& are enrolled into study. Patients may or may not have taken study drug. One (1) Ph+ CML patient in Group 2 was Ph+ at baseline \& discontinued study prior to subsequent cytogenetic assessment. This pt doesn't appear in any cytogenic response category.
Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is \> 0% to 35%, minor cytogenetic response (mCyR) is \> 35% to 65%, minimal response is \> 65% to 95% and no response is \> 95% Ph+ metaphases in the BM.
Outcome measures
| Measure |
Group 1
n=5 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=6 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Number of Ph+ CML Participants With Cytogenic Response
Complete cytogenic response (CCyR)
|
2 Participants
|
2 Participants
|
|
Number of Ph+ CML Participants With Cytogenic Response
Partial cytogenic response (PCyR)
|
0 Participants
|
1 Participants
|
|
Number of Ph+ CML Participants With Cytogenic Response
Minor cytogenic response (mCyR)
|
0 Participants
|
1 Participants
|
|
Number of Ph+ CML Participants With Cytogenic Response
Minimal
|
0 Participants
|
0 Participants
|
|
Number of Ph+ CML Participants With Cytogenic Response
None
|
0 Participants
|
0 Participants
|
|
Number of Ph+ CML Participants With Cytogenic Response
Absence of Ph+ at baseline
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: minimum of 12 cycles (28 days per cycle)Population: Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
The bcr-abl gene fusion encodes for a BCR-ABL fusion protein. Depending on the precise location of the fusion, the molecular weight of this protein can range from 185 to 210 kDa. Consequently BCR-ABL is referred to as p185 or p210 transcript. For the patients expressing the major BCR-ABL transcript p210, molecular response was defined and reported as the percent ratio of BCR-ABL transcripts/control gene transcripts converted to a reference standard according to the International Scale (IS). A major molecular response (MMR) is defined as a BCR-ABL/control gene ratio ≤ 0.1% (equal to a 3 log reduction in BCR-ABL transcripts) on the IS. In this study, the control gene was abl.
Outcome measures
| Measure |
Group 1
n=5 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=6 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Number of Ph+ CML Participants With Major Molecular Response (MMR)
Yes
|
1 Participants
|
2 Participants
|
|
Number of Ph+ CML Participants With Major Molecular Response (MMR)
No
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: minimum of 12 cycles (28 days per cycle)Population: Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease.
Outcome measures
| Measure |
Group 1
n=3 Participants
1 year to \< 10 years pediatric patients
|
Group 2
n=1 Participants
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Efficacy Endpoints for Ph+ ALL Patients
Complete Remission with platelet recovery
|
2 Participants
|
1 Participants
|
|
Efficacy Endpoints for Ph+ ALL Patients
Complete Remission w/incomplete platelet recovery
|
0 Participants
|
0 Participants
|
|
Efficacy Endpoints for Ph+ ALL Patients
Partial remission
|
0 Participants
|
0 Participants
|
|
Efficacy Endpoints for Ph+ ALL Patients
Stable disease
|
1 Participants
|
0 Participants
|
|
Efficacy Endpoints for Ph+ ALL Patients
Progressive disease
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1
Group 2
Serious adverse events
| Measure |
Group 1
n=8 participants at risk
1 year to \< 10 years pediatric patients
|
Group 2
n=7 participants at risk
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8
|
28.6%
2/7
|
|
Gastrointestinal disorders
Appendix disorder
|
12.5%
1/8
|
0.00%
0/7
|
|
General disorders
Influenza like illness
|
12.5%
1/8
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
12.5%
1/8
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8
|
14.3%
1/7
|
Other adverse events
| Measure |
Group 1
n=8 participants at risk
1 year to \< 10 years pediatric patients
|
Group 2
n=7 participants at risk
\>= 10 years to \<18 years pediatric patients
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/8
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8
|
14.3%
1/7
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8
|
28.6%
2/7
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8
|
28.6%
2/7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8
|
14.3%
1/7
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
14.3%
1/7
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8
|
42.9%
3/7
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
42.9%
3/7
|
|
Gastrointestinal disorders
Odynophagia
|
12.5%
1/8
|
0.00%
0/7
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8
|
14.3%
1/7
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8
|
42.9%
3/7
|
|
General disorders
Asthenia
|
0.00%
0/8
|
14.3%
1/7
|
|
General disorders
Catheter site pain
|
12.5%
1/8
|
0.00%
0/7
|
|
General disorders
Fatigue
|
25.0%
2/8
|
0.00%
0/7
|
|
General disorders
Malaise
|
0.00%
0/8
|
14.3%
1/7
|
|
General disorders
Mucosal inflammation
|
0.00%
0/8
|
14.3%
1/7
|
|
General disorders
Pyrexia
|
12.5%
1/8
|
14.3%
1/7
|
|
General disorders
Xerosis
|
12.5%
1/8
|
0.00%
0/7
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
25.0%
2/8
|
28.6%
2/7
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8
|
14.3%
1/7
|
|
Infections and infestations
Device related infection
|
12.5%
1/8
|
0.00%
0/7
|
|
Infections and infestations
Ear infection
|
12.5%
1/8
|
0.00%
0/7
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8
|
28.6%
2/7
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/8
|
14.3%
1/7
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
12.5%
1/8
|
0.00%
0/7
|
|
Infections and infestations
Lip infection
|
0.00%
0/8
|
14.3%
1/7
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
4/8
|
0.00%
0/7
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8
|
14.3%
1/7
|
|
Infections and infestations
Otitis media
|
12.5%
1/8
|
0.00%
0/7
|
|
Infections and infestations
Rhinitis
|
37.5%
3/8
|
14.3%
1/7
|
|
Infections and infestations
Skin infection
|
0.00%
0/8
|
28.6%
2/7
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/8
|
14.3%
1/7
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8
|
14.3%
1/7
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8
|
14.3%
1/7
|
|
Investigations
Alanine aminotransferase increased
|
37.5%
3/8
|
14.3%
1/7
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
3/8
|
0.00%
0/7
|
|
Investigations
Bilirubin conjugated increased
|
12.5%
1/8
|
14.3%
1/7
|
|
Investigations
Blood bilirubin increased
|
25.0%
2/8
|
42.9%
3/7
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/8
|
14.3%
1/7
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8
|
28.6%
2/7
|
|
Investigations
Blood phosphorus decreased
|
12.5%
1/8
|
0.00%
0/7
|
|
Investigations
Blood sodium decreased
|
12.5%
1/8
|
0.00%
0/7
|
|
Investigations
Blood urea increased
|
0.00%
0/8
|
28.6%
2/7
|
|
Investigations
Blood uric acid increased
|
0.00%
0/8
|
28.6%
2/7
|
|
Investigations
Electrocardiogram QT prolonged
|
12.5%
1/8
|
0.00%
0/7
|
|
Investigations
Haematocrit decreased
|
0.00%
0/8
|
14.3%
1/7
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8
|
14.3%
1/7
|
|
Investigations
Neutrophil count increased
|
0.00%
0/8
|
14.3%
1/7
|
|
Investigations
Platelet count decreased
|
0.00%
0/8
|
14.3%
1/7
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/8
|
14.3%
1/7
|
|
Investigations
Weight decreased
|
12.5%
1/8
|
0.00%
0/7
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8
|
14.3%
1/7
|
|
Investigations
White blood cell count increased
|
0.00%
0/8
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
1/8
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8
|
42.9%
3/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
37.5%
3/8
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/8
|
14.3%
1/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
25.0%
2/8
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
50.0%
4/8
|
28.6%
2/7
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8
|
14.3%
1/7
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8
|
0.00%
0/7
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8
|
14.3%
1/7
|
|
Nervous system disorders
Syncope
|
0.00%
0/8
|
14.3%
1/7
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
12.5%
1/8
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8
|
28.6%
2/7
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
12.5%
1/8
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
12.5%
1/8
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8
|
28.6%
2/7
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/8
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Eczema
|
25.0%
2/8
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
12.5%
1/8
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
12.5%
1/8
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8
|
28.6%
2/7
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
12.5%
1/8
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
12.5%
1/8
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8
|
14.3%
1/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER