Trial Outcomes & Findings for A Study of Nilotinib Versus Imatinib in GIST Patients (NCT NCT00785785)
NCT ID: NCT00785785
Last Updated: 2016-06-16
Results Overview
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
644 participants
Primary outcome timeframe
up to month 37
Results posted on
2016-06-16
Participant Flow
Participant milestones
| Measure |
Imatinib First, Then Nilotinib
patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
|
Nilotinib First, Then Imatinib
patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
|
|---|---|---|
|
Core Phase up to 36 Months
STARTED
|
324
|
320
|
|
Core Phase up to 36 Months
COMPLETED
|
0
|
0
|
|
Core Phase up to 36 Months
NOT COMPLETED
|
324
|
320
|
|
Optional Extension Phase
STARTED
|
39
|
125
|
|
Optional Extension Phase
COMPLETED
|
0
|
0
|
|
Optional Extension Phase
NOT COMPLETED
|
39
|
125
|
Reasons for withdrawal
| Measure |
Imatinib First, Then Nilotinib
patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
|
Nilotinib First, Then Imatinib
patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
|
|---|---|---|
|
Core Phase up to 36 Months
Patients didn't receive 1st line therapy
|
3
|
4
|
|
Core Phase up to 36 Months
Adverse Event
|
31
|
21
|
|
Core Phase up to 36 Months
Abnormal laboratory value
|
1
|
0
|
|
Core Phase up to 36 Months
Abnormal test procedure result
|
2
|
2
|
|
Core Phase up to 36 Months
Withdrawal by Subject
|
16
|
17
|
|
Core Phase up to 36 Months
Lost to Follow-up
|
3
|
7
|
|
Core Phase up to 36 Months
Administrative problems
|
3
|
3
|
|
Core Phase up to 36 Months
Death
|
5
|
8
|
|
Core Phase up to 36 Months
Disease progression
|
139
|
119
|
|
Core Phase up to 36 Months
Protocol deviation
|
5
|
6
|
|
Core Phase up to 36 Months
Study terminated by sponsor
|
116
|
133
|
|
Optional Extension Phase
Adverse Event
|
4
|
5
|
|
Optional Extension Phase
Withdrawal by Subject
|
6
|
6
|
|
Optional Extension Phase
Lost to Follow-up
|
1
|
0
|
|
Optional Extension Phase
Administrative problems
|
2
|
0
|
|
Optional Extension Phase
Death
|
1
|
5
|
|
Optional Extension Phase
Disease progression
|
22
|
70
|
|
Optional Extension Phase
Protocol deviation
|
0
|
2
|
|
Optional Extension Phase
Study terminated by sponsor
|
3
|
37
|
Baseline Characteristics
A Study of Nilotinib Versus Imatinib in GIST Patients
Baseline characteristics by cohort
| Measure |
Imatinib First, Then Nilotinib
n=324 Participants
patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
|
Nilotinib First, Then Imatinib
n=320 Participants
patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
|
Total
n=644 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 12.91 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 12.63 • n=7 Participants
|
57.35 years
STANDARD_DEVIATION 12.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to month 37Population: Full Analysis Set (FAS) consists of all randomized patients for the Core Phase.
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Nilotinib
n=324 Participants
nilotinib 400 mg twice a day
|
Imatinib
n=320 Participants
imatinib 400 mg once daily
|
|---|---|---|
|
Time to Progression Free Survival (PFS)
|
25.9 months
Interval 0.0 to 32.8
|
29.7 months
Interval 0.0 to 36.1
|
Adverse Events
Nilotinib
Serious events: 80 serious events
Other events: 291 other events
Deaths: 0 deaths
Imatinib
Serious events: 85 serious events
Other events: 289 other events
Deaths: 0 deaths
Crossover Nilotinib
Serious events: 15 serious events
Other events: 28 other events
Deaths: 0 deaths
Crossover Imatinib
Serious events: 26 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nilotinib
n=321 participants at risk
Exposure to Nilotinib only
|
Imatinib
n=316 participants at risk
Exposure to Imatinib only
|
Crossover Nilotinib
n=39 participants at risk
exposure to imatinib and then nilotinib
|
Crossover Imatinib
n=125 participants at risk
exposure to nilotinib and then imatinib
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
6/321
|
0.95%
3/316
|
5.1%
2/39
|
2.4%
3/125
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Acute myocardial infarction
|
0.62%
2/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Angina pectoris
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Cardiac disorders
Angina unstable
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Cardiac arrest
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Cardiac disorders
Cardiac failure congestive
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Palpitations
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Pericardial effusion
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
15/321
|
3.8%
12/316
|
10.3%
4/39
|
2.4%
3/125
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Anal fissure
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Ascites
|
0.62%
2/321
|
0.32%
1/316
|
0.00%
0/39
|
1.6%
2/125
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/321
|
0.00%
0/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Constipation
|
0.93%
3/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Diarrhoea
|
0.31%
1/321
|
1.3%
4/316
|
0.00%
0/39
|
1.6%
2/125
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Gastritis
|
0.62%
2/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
5/321
|
1.6%
5/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Haematemesis
|
0.31%
1/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Ileus
|
0.62%
2/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
4/321
|
0.63%
2/316
|
2.6%
1/39
|
2.4%
3/125
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Nausea
|
0.62%
2/321
|
0.63%
2/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/321
|
0.00%
0/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Subileus
|
0.62%
2/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
5/321
|
0.95%
3/316
|
2.6%
1/39
|
3.2%
4/125
|
|
General disorders
Asthenia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
General disorders
Death
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
General disorders
Disease progression
|
0.00%
0/321
|
0.00%
0/316
|
2.6%
1/39
|
0.80%
1/125
|
|
General disorders
Face oedema
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
General disorders
Fatigue
|
0.00%
0/321
|
0.63%
2/316
|
0.00%
0/39
|
0.80%
1/125
|
|
General disorders
General physical health deterioration
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
General disorders
Generalised oedema
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
General disorders
Multi-organ failure
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.80%
1/125
|
|
General disorders
Oedema mucosal
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
General disorders
Oedema peripheral
|
0.31%
1/321
|
0.95%
3/316
|
2.6%
1/39
|
0.00%
0/125
|
|
General disorders
Pain
|
0.00%
0/321
|
0.00%
0/316
|
5.1%
2/39
|
0.80%
1/125
|
|
General disorders
Performance status decreased
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
General disorders
Pyrexia
|
0.62%
2/321
|
1.9%
6/316
|
0.00%
0/39
|
2.4%
3/125
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Hepatobiliary disorders
Cholangitis
|
0.62%
2/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Hepatobiliary disorders
Hepatic failure
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/321
|
0.00%
0/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Hepatobiliary disorders
Jaundice
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.31%
1/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Immune system disorders
Hypersensitivity
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Abdominal infection
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Infections and infestations
Appendicitis
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Bacterial sepsis
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Bronchitis
|
0.00%
0/321
|
0.32%
1/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Infections and infestations
Cellulitis
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Ear infection
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Eye infection
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Gastroenteritis
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Helicobacter gastritis
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Infection
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Infectious pleural effusion
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Lung infection
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Periodontitis
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Peritonitis
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Pneumonia
|
0.93%
3/321
|
1.3%
4/316
|
2.6%
1/39
|
0.80%
1/125
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/321
|
0.00%
0/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Sepsis
|
0.62%
2/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Septic shock
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Upper respiratory tract infection
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Urinary tract infection
|
1.2%
4/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Infections and infestations
Viral infection
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Injury, poisoning and procedural complications
Overdose
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Investigations
Blood bilirubin increased
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Investigations
Blood creatinine increased
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Investigations
Blood potassium decreased
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Investigations
Lipase increased
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Investigations
Weight decreased
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.2%
4/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
2.4%
3/125
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.93%
3/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.31%
1/321
|
0.95%
3/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
3/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.93%
3/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract neoplasm
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Altered state of consciousness
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Cerebral infarction
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Cerebral ischaemia
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Cognitive disorder
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Complex partial seizures
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Convulsion
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Dizziness
|
0.00%
0/321
|
0.00%
0/316
|
5.1%
2/39
|
0.00%
0/125
|
|
Nervous system disorders
Epilepsy
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Headache
|
0.31%
1/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Loss of consciousness
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Migraine
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Myelitis transverse
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Sciatica
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Nervous system disorders
Syncope
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/321
|
0.63%
2/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Renal and urinary disorders
Pollakiuria
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/321
|
0.00%
0/316
|
2.6%
1/39
|
0.80%
1/125
|
|
Renal and urinary disorders
Renal failure acute
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
2/321
|
0.32%
1/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/321
|
0.00%
0/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/321
|
0.32%
1/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Surgical and medical procedures
Cytoreductive surgery
|
0.00%
0/321
|
0.00%
0/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Surgical and medical procedures
Gastrectomy
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Surgical and medical procedures
Tumour excision
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Vascular disorders
Deep vein thrombosis
|
0.31%
1/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Vascular disorders
Femoral artery occlusion
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Vascular disorders
Hypotension
|
0.31%
1/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.62%
2/321
|
0.00%
0/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Vascular disorders
Thrombosis
|
0.00%
0/321
|
0.00%
0/316
|
2.6%
1/39
|
0.00%
0/125
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/321
|
0.32%
1/316
|
0.00%
0/39
|
0.00%
0/125
|
Other adverse events
| Measure |
Nilotinib
n=321 participants at risk
Exposure to Nilotinib only
|
Imatinib
n=316 participants at risk
Exposure to Imatinib only
|
Crossover Nilotinib
n=39 participants at risk
exposure to imatinib and then nilotinib
|
Crossover Imatinib
n=125 participants at risk
exposure to nilotinib and then imatinib
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
38/321
|
19.3%
61/316
|
17.9%
7/39
|
16.0%
20/125
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
4/321
|
11.1%
35/316
|
2.6%
1/39
|
8.0%
10/125
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
4/321
|
13.3%
42/316
|
2.6%
1/39
|
8.8%
11/125
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.62%
2/321
|
1.6%
5/316
|
5.1%
2/39
|
0.80%
1/125
|
|
Eye disorders
Eyelid oedema
|
1.6%
5/321
|
17.4%
55/316
|
0.00%
0/39
|
15.2%
19/125
|
|
Eye disorders
Lacrimation increased
|
0.93%
3/321
|
6.6%
21/316
|
0.00%
0/39
|
2.4%
3/125
|
|
Eye disorders
Periorbital oedema
|
0.62%
2/321
|
18.4%
58/316
|
0.00%
0/39
|
7.2%
9/125
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
17/321
|
3.8%
12/316
|
2.6%
1/39
|
0.80%
1/125
|
|
Gastrointestinal disorders
Abdominal pain
|
19.6%
63/321
|
19.3%
61/316
|
15.4%
6/39
|
14.4%
18/125
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.8%
38/321
|
4.7%
15/316
|
2.6%
1/39
|
4.0%
5/125
|
|
Gastrointestinal disorders
Constipation
|
15.3%
49/321
|
7.6%
24/316
|
7.7%
3/39
|
2.4%
3/125
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
46/321
|
33.5%
106/316
|
5.1%
2/39
|
13.6%
17/125
|
|
Gastrointestinal disorders
Nausea
|
22.7%
73/321
|
33.2%
105/316
|
30.8%
12/39
|
16.0%
20/125
|
|
Gastrointestinal disorders
Stomatitis
|
3.1%
10/321
|
4.4%
14/316
|
5.1%
2/39
|
0.80%
1/125
|
|
Gastrointestinal disorders
Vomiting
|
15.9%
51/321
|
20.6%
65/316
|
12.8%
5/39
|
8.0%
10/125
|
|
General disorders
Asthenia
|
8.4%
27/321
|
9.2%
29/316
|
0.00%
0/39
|
4.8%
6/125
|
|
General disorders
Face oedema
|
1.6%
5/321
|
13.6%
43/316
|
0.00%
0/39
|
10.4%
13/125
|
|
General disorders
Fatigue
|
20.6%
66/321
|
20.6%
65/316
|
17.9%
7/39
|
9.6%
12/125
|
|
General disorders
Oedema peripheral
|
9.0%
29/321
|
21.5%
68/316
|
5.1%
2/39
|
13.6%
17/125
|
|
General disorders
Pyrexia
|
7.2%
23/321
|
9.5%
30/316
|
7.7%
3/39
|
3.2%
4/125
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
19.6%
63/321
|
3.5%
11/316
|
7.7%
3/39
|
2.4%
3/125
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
25/321
|
6.0%
19/316
|
2.6%
1/39
|
0.80%
1/125
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
8/321
|
5.4%
17/316
|
0.00%
0/39
|
0.80%
1/125
|
|
Investigations
Alanine aminotransferase increased
|
14.0%
45/321
|
5.7%
18/316
|
12.8%
5/39
|
2.4%
3/125
|
|
Investigations
Amylase increased
|
2.5%
8/321
|
4.1%
13/316
|
5.1%
2/39
|
1.6%
2/125
|
|
Investigations
Aspartate aminotransferase increased
|
7.2%
23/321
|
4.7%
15/316
|
5.1%
2/39
|
1.6%
2/125
|
|
Investigations
Blood alkaline phosphatase increased
|
2.2%
7/321
|
0.95%
3/316
|
7.7%
3/39
|
1.6%
2/125
|
|
Investigations
Blood bilirubin increased
|
10.0%
32/321
|
1.3%
4/316
|
5.1%
2/39
|
0.80%
1/125
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.8%
9/321
|
0.63%
2/316
|
10.3%
4/39
|
0.80%
1/125
|
|
Investigations
Haemoglobin decreased
|
3.1%
10/321
|
6.3%
20/316
|
7.7%
3/39
|
4.0%
5/125
|
|
Investigations
Lipase increased
|
8.4%
27/321
|
7.3%
23/316
|
2.6%
1/39
|
4.8%
6/125
|
|
Investigations
Neutrophil count decreased
|
0.62%
2/321
|
7.6%
24/316
|
2.6%
1/39
|
5.6%
7/125
|
|
Investigations
Weight decreased
|
8.4%
27/321
|
6.3%
20/316
|
7.7%
3/39
|
2.4%
3/125
|
|
Investigations
White blood cell count decreased
|
0.93%
3/321
|
6.6%
21/316
|
0.00%
0/39
|
8.8%
11/125
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
40/321
|
15.8%
50/316
|
12.8%
5/39
|
4.0%
5/125
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.7%
15/321
|
2.2%
7/316
|
5.1%
2/39
|
1.6%
2/125
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.62%
2/321
|
1.6%
5/316
|
5.1%
2/39
|
0.80%
1/125
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.8%
9/321
|
6.0%
19/316
|
0.00%
0/39
|
6.4%
8/125
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
20/321
|
16.8%
53/316
|
7.7%
3/39
|
8.0%
10/125
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
20/321
|
4.7%
15/316
|
5.1%
2/39
|
2.4%
3/125
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
32/321
|
5.7%
18/316
|
7.7%
3/39
|
2.4%
3/125
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
18/321
|
14.9%
47/316
|
2.6%
1/39
|
1.6%
2/125
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.1%
39/321
|
5.4%
17/316
|
5.1%
2/39
|
1.6%
2/125
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
22/321
|
5.1%
16/316
|
5.1%
2/39
|
2.4%
3/125
|
|
Nervous system disorders
Dizziness
|
6.9%
22/321
|
6.0%
19/316
|
5.1%
2/39
|
3.2%
4/125
|
|
Nervous system disorders
Dysgeusia
|
3.1%
10/321
|
2.8%
9/316
|
5.1%
2/39
|
2.4%
3/125
|
|
Nervous system disorders
Headache
|
16.8%
54/321
|
7.6%
24/316
|
12.8%
5/39
|
1.6%
2/125
|
|
Psychiatric disorders
Insomnia
|
6.5%
21/321
|
6.3%
20/316
|
2.6%
1/39
|
1.6%
2/125
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
28/321
|
6.6%
21/316
|
2.6%
1/39
|
2.4%
3/125
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
17/321
|
6.6%
21/316
|
5.1%
2/39
|
4.0%
5/125
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.3%
33/321
|
4.1%
13/316
|
2.6%
1/39
|
2.4%
3/125
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
19/321
|
6.6%
21/316
|
0.00%
0/39
|
2.4%
3/125
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.1%
39/321
|
7.9%
25/316
|
10.3%
4/39
|
1.6%
2/125
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.7%
89/321
|
14.6%
46/316
|
10.3%
4/39
|
9.6%
12/125
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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 the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER