Trial Outcomes & Findings for Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) (NCT NCT01974752)
NCT ID: NCT01974752
Last Updated: 2017-01-05
Results Overview
Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). 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
152 participants
Primary outcome timeframe
From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
Results posted on
2017-01-05
Participant Flow
Participant milestones
| Measure |
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
Placebo + Dacarbazine 1000 mg/m2
Placebo + Dacarbazine 1000 mg/m2
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
32
|
|
Overall Study
COMPLETED
|
60
|
17
|
|
Overall Study
NOT COMPLETED
|
37
|
15
|
Reasons for withdrawal
| Measure |
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
Placebo + Dacarbazine 1000 mg/m2
Placebo + Dacarbazine 1000 mg/m2
|
|---|---|---|
|
Overall Study
Death
|
33
|
11
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Other Eligibility Criteria
|
0
|
1
|
Baseline Characteristics
Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT)
Baseline characteristics by cohort
| Measure |
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
n=97 Participants
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
Placebo + Dacarbazine 1000 mg/m2
n=32 Participants
Placebo + Dacarbazine 1000 mg/m2
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 Years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
59.6 Years
STANDARD_DEVIATION 11.28 • n=7 Participants
|
60.6 Years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
|
Age, Customized
<55 years
|
26 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Customized
>=55 years To <65 years
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
46 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Gender
Female
|
42 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Gender
Male
|
55 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
96 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015Population: All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).
Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). 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 |
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
n=97 Participants
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
Placebo + Dacarbazine 1000 mg/m2
n=32 Participants
Placebo + Dacarbazine 1000 mg/m2
|
|---|---|---|
|
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.
|
82 number of progression events
Interval 2.8 to 2.8
|
24 number of progression events
Interval 1.8 to 1.8
|
SECONDARY outcome
Timeframe: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015Population: Full Analysis Set
ORR at Week 6 using BICR according to RECIST 1.1
Outcome measures
| Measure |
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
n=97 Participants
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
Placebo + Dacarbazine 1000 mg/m2
n=32 Participants
Placebo + Dacarbazine 1000 mg/m2
|
|---|---|---|
|
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR
|
3 number of responders
|
0 number of responders
|
SECONDARY outcome
Timeframe: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015Population: All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).
Percent change in tumour size at Week 6 using BICR according to RECIST 1.1
Outcome measures
| Measure |
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
n=92 Participants
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
Placebo + Dacarbazine 1000 mg/m2
n=27 Participants
Placebo + Dacarbazine 1000 mg/m2
|
|---|---|---|
|
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR
|
6.94 percent change
Standard Deviation 18.001 • Interval 6.94 to 6.94
|
19.76 percent change
Standard Deviation 38.264 • Interval 19.76 to 19.76
|
SECONDARY outcome
Timeframe: From Randomization, up until death assessed up to 15th May 2015Population: All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).
Overall Survival
Outcome measures
| Measure |
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
n=97 Participants
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
Placebo + Dacarbazine 1000 mg/m2
n=32 Participants
Placebo + Dacarbazine 1000 mg/m2
|
|---|---|---|
|
Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine
|
34 Number of Overall Survival Events
|
14 Number of Overall Survival Events
|
Adverse Events
Placebo + Dacarbazine 1000 mg/m2
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
Serious events: 20 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Dacarbazine 1000 mg/m2
n=32 participants at risk
Placebo + Dacarbazine 1000 mg/m2
|
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
n=97 participants at risk
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 2 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
0.00%
0/97 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
General disorders
ASTHENIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
General disorders
CHEST PAIN
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
General disorders
PYREXIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
2.1%
2/97 • Number of events 2 • From informed consent up until end of double blind period
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Infections and infestations
STREPTOCOCCAL BACTERAEMIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
2.1%
2/97 • Number of events 2 • From informed consent up until end of double blind period
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/32 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
Other adverse events
| Measure |
Placebo + Dacarbazine 1000 mg/m2
n=32 participants at risk
Placebo + Dacarbazine 1000 mg/m2
|
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
n=97 participants at risk
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
|
|---|---|---|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 6 • From informed consent up until end of double blind period
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
12.5%
4/32 • Number of events 6 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 6 • From informed consent up until end of double blind period
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/32 • From informed consent up until end of double blind period
|
9.3%
9/97 • Number of events 10 • From informed consent up until end of double blind period
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
9.4%
3/32 • Number of events 4 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
4.1%
4/97 • Number of events 4 • From informed consent up until end of double blind period
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
12.4%
12/97 • Number of events 14 • From informed consent up until end of double blind period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
2.1%
2/97 • Number of events 3 • From informed consent up until end of double blind period
|
|
Nervous system disorders
DIZZINESS
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
6.2%
6/97 • Number of events 7 • From informed consent up until end of double blind period
|
|
Nervous system disorders
DYSGEUSIA
|
9.4%
3/32 • Number of events 4 • From informed consent up until end of double blind period
|
11.3%
11/97 • Number of events 11 • From informed consent up until end of double blind period
|
|
Nervous system disorders
HEADACHE
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
13.4%
13/97 • Number of events 13 • From informed consent up until end of double blind period
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/32 • From informed consent up until end of double blind period
|
6.2%
6/97 • Number of events 7 • From informed consent up until end of double blind period
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
9.3%
9/97 • Number of events 9 • From informed consent up until end of double blind period
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 6 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
6.2%
6/97 • Number of events 6 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
30.9%
30/97 • Number of events 37 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
3.1%
3/97 • Number of events 3 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
0.00%
0/97 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.5%
4/32 • Number of events 5 • From informed consent up until end of double blind period
|
14.4%
14/97 • Number of events 15 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
56.7%
55/97 • Number of events 60 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
0.00%
0/32 • From informed consent up until end of double blind period
|
12.4%
12/97 • Number of events 14 • From informed consent up until end of double blind period
|
|
Vascular disorders
HYPERTENSION
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
19.6%
19/97 • Number of events 19 • From informed consent up until end of double blind period
|
|
Blood and lymphatic system disorders
ANAEMIA
|
12.5%
4/32 • Number of events 6 • From informed consent up until end of double blind period
|
18.6%
18/97 • Number of events 22 • From informed consent up until end of double blind period
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
34.4%
11/32 • Number of events 14 • From informed consent up until end of double blind period
|
25.8%
25/97 • Number of events 35 • From informed consent up until end of double blind period
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
12.5%
4/32 • Number of events 4 • From informed consent up until end of double blind period
|
26.8%
26/97 • Number of events 39 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
CONSTIPATION
|
43.8%
14/32 • Number of events 19 • From informed consent up until end of double blind period
|
38.1%
37/97 • Number of events 46 • From informed consent up until end of double blind period
|
|
General disorders
ASTHENIA
|
12.5%
4/32 • Number of events 5 • From informed consent up until end of double blind period
|
20.6%
20/97 • Number of events 21 • From informed consent up until end of double blind period
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
6.2%
2/32 • Number of events 3 • From informed consent up until end of double blind period
|
6.2%
6/97 • Number of events 6 • From informed consent up until end of double blind period
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
6.2%
2/32 • Number of events 4 • From informed consent up until end of double blind period
|
4.1%
4/97 • Number of events 5 • From informed consent up until end of double blind period
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/32 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 5 • From informed consent up until end of double blind period
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 5 • From informed consent up until end of double blind period
|
|
Nervous system disorders
PARAESTHESIA
|
6.2%
2/32 • Number of events 4 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 5 • From informed consent up until end of double blind period
|
|
Psychiatric disorders
INSOMNIA
|
12.5%
4/32 • Number of events 4 • From informed consent up until end of double blind period
|
8.2%
8/97 • Number of events 8 • From informed consent up until end of double blind period
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
19.6%
19/97 • Number of events 23 • From informed consent up until end of double blind period
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
4.1%
4/97 • Number of events 4 • From informed consent up until end of double blind period
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/32 • From informed consent up until end of double blind period
|
11.3%
11/97 • Number of events 12 • From informed consent up until end of double blind period
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
0.00%
0/97 • From informed consent up until end of double blind period
|
|
Eye disorders
VISION BLURRED
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
10.3%
10/97 • Number of events 11 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
11.3%
11/97 • Number of events 12 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
9.4%
3/32 • Number of events 4 • From informed consent up until end of double blind period
|
8.2%
8/97 • Number of events 8 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
DIARRHOEA
|
21.9%
7/32 • Number of events 11 • From informed consent up until end of double blind period
|
44.3%
43/97 • Number of events 83 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
9.3%
9/97 • Number of events 9 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
11.3%
11/97 • Number of events 12 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
0.00%
0/97 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 5 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
NAUSEA
|
18.8%
6/32 • Number of events 12 • From informed consent up until end of double blind period
|
61.9%
60/97 • Number of events 92 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
STOMATITIS
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
15.5%
15/97 • Number of events 16 • From informed consent up until end of double blind period
|
|
Gastrointestinal disorders
VOMITING
|
18.8%
6/32 • Number of events 7 • From informed consent up until end of double blind period
|
27.8%
27/97 • Number of events 36 • From informed consent up until end of double blind period
|
|
General disorders
CHILLS
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 6 • From informed consent up until end of double blind period
|
|
General disorders
FACE OEDEMA
|
0.00%
0/32 • From informed consent up until end of double blind period
|
6.2%
6/97 • Number of events 7 • From informed consent up until end of double blind period
|
|
General disorders
FATIGUE
|
46.9%
15/32 • Number of events 16 • From informed consent up until end of double blind period
|
44.3%
43/97 • Number of events 49 • From informed consent up until end of double blind period
|
|
General disorders
OEDEMA PERIPHERAL
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
43.3%
42/97 • Number of events 47 • From informed consent up until end of double blind period
|
|
General disorders
PYREXIA
|
15.6%
5/32 • Number of events 6 • From informed consent up until end of double blind period
|
8.2%
8/97 • Number of events 9 • From informed consent up until end of double blind period
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
3.1%
3/97 • Number of events 3 • From informed consent up until end of double blind period
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/32 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 5 • From informed consent up until end of double blind period
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
0.00%
0/97 • From informed consent up until end of double blind period
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 6 • From informed consent up until end of double blind period
|
|
Infections and infestations
URINARY TRACT INFECTION
|
9.4%
3/32 • Number of events 3 • From informed consent up until end of double blind period
|
9.3%
9/97 • Number of events 9 • From informed consent up until end of double blind period
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
15.6%
5/32 • Number of events 7 • From informed consent up until end of double blind period
|
28.9%
28/97 • Number of events 36 • From informed consent up until end of double blind period
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
15.6%
5/32 • Number of events 8 • From informed consent up until end of double blind period
|
29.9%
29/97 • Number of events 36 • From informed consent up until end of double blind period
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
6.2%
2/32 • Number of events 3 • From informed consent up until end of double blind period
|
8.2%
8/97 • Number of events 8 • From informed consent up until end of double blind period
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
37.1%
36/97 • Number of events 40 • From informed consent up until end of double blind period
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
3.1%
1/32 • Number of events 1 • From informed consent up until end of double blind period
|
6.2%
6/97 • Number of events 8 • From informed consent up until end of double blind period
|
|
Investigations
PLATELET COUNT DECREASED
|
9.4%
3/32 • Number of events 4 • From informed consent up until end of double blind period
|
7.2%
7/97 • Number of events 10 • From informed consent up until end of double blind period
|
|
Investigations
WEIGHT DECREASED
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
1.0%
1/97 • Number of events 1 • From informed consent up until end of double blind period
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
28.1%
9/32 • Number of events 9 • From informed consent up until end of double blind period
|
17.5%
17/97 • Number of events 18 • From informed consent up until end of double blind period
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
6.2%
2/32 • Number of events 3 • From informed consent up until end of double blind period
|
5.2%
5/97 • Number of events 6 • From informed consent up until end of double blind period
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
6.2%
2/32 • Number of events 2 • From informed consent up until end of double blind period
|
6.2%
6/97 • Number of events 8 • From informed consent up until end of double blind period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place