Trial Outcomes & Findings for Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea (NCT NCT00582426)
NCT ID: NCT00582426
Last Updated: 2015-05-04
Results Overview
The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
COMPLETED
PHASE3
139 participants
6 month overall
2015-05-04
Participant Flow
Participant milestones
| Measure |
Octreotide Long Acting Release
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
71
|
|
Overall Study
COMPLETED
|
48
|
58
|
|
Overall Study
NOT COMPLETED
|
20
|
13
|
Reasons for withdrawal
| Measure |
Octreotide Long Acting Release
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Protocol Violation
|
6
|
2
|
|
Overall Study
Death
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Disease Progression
|
2
|
2
|
|
Overall Study
Use of illicit drugs
|
1
|
0
|
Baseline Characteristics
Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea
Baseline characteristics by cohort
| Measure |
Octreotide Long Acting Release
n=68 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=71 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
55.85 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 month overallPopulation: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the "Octreotide Long Acting Release" Arm discontinued due to exclusion criteria after visit 1.
The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=67 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=71 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Percentage of Participants Developing Diarrhea (Grade 1 to 4)
|
76.1 Percentage of Participants
Interval 64.7 to 84.7
|
78.9 Percentage of Participants
Interval 68.0 to 86.8
|
SECONDARY outcome
Timeframe: 6 months overallPopulation: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.
Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=51 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=56 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Number of Episodes of Diarrhea by Patient
|
21.6 Episodes/patients/day
Standard Deviation 24.3
|
20.4 Episodes/patients/day
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: at each cycle (28 days per cycle)Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. "n" indicates patients with observations during each cycle.
Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.)
Outcome measures
| Measure |
Octreotide Long Acting Release
n=51 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=56 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Number of Episodes of Diarrhea by Patient by Cycle
Cycle 1 (n=20, 18)
|
2.6 Episodes/patient/cycle
Standard Deviation 2.2
|
2.2 Episodes/patient/cycle
Standard Deviation 2
|
|
Number of Episodes of Diarrhea by Patient by Cycle
Cycle 2 (n=36,38)
|
8.2 Episodes/patient/cycle
Standard Deviation 6.8
|
5.9 Episodes/patient/cycle
Standard Deviation 6.2
|
|
Number of Episodes of Diarrhea by Patient by Cycle
Cycle 3 (n=33,39)
|
6.9 Episodes/patient/cycle
Standard Deviation 7.8
|
6.7 Episodes/patient/cycle
Standard Deviation 6.5
|
|
Number of Episodes of Diarrhea by Patient by Cycle
Cycle 4 (n=24, 27)
|
8.6 Episodes/patient/cycle
Standard Deviation 7.1
|
7.1 Episodes/patient/cycle
Standard Deviation 7.1
|
|
Number of Episodes of Diarrhea by Patient by Cycle
Cycle 5 (n=20,29)
|
8.1 Episodes/patient/cycle
Standard Deviation 7.1
|
7 Episodes/patient/cycle
Standard Deviation 8.8
|
|
Number of Episodes of Diarrhea by Patient by Cycle
Cycle 6 (n=22, 22)
|
6.1 Episodes/patient/cycle
Standard Deviation 6.9
|
5.8 Episodes/patient/cycle
Standard Deviation 5.3
|
|
Number of Episodes of Diarrhea by Patient by Cycle
Cycle 7 (n= 16, 20)
|
4.8 Episodes/patient/cycle
Standard Deviation 6.3
|
6.6 Episodes/patient/cycle
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 6 months overallPopulation: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.
Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=51 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=56 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Percentage of Patients by Grade of Diarrhea
Grade 1
|
41.2 Percentage of Participants
|
26.8 Percentage of Participants
|
|
Percentage of Patients by Grade of Diarrhea
Grade 2
|
25.5 Percentage of Participants
|
51.8 Percentage of Participants
|
|
Percentage of Patients by Grade of Diarrhea
Grade 3
|
33.3 Percentage of Participants
|
21.4 Percentage of Participants
|
|
Percentage of Patients by Grade of Diarrhea
Grade 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 months overallPopulation: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.
Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=257 Episodes of Diarrhea
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=272 Episodes of Diarrhea
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Percentage of Episodes by Grade
Grade 1
|
65.4 Percentage of Episodes
|
66.9 Percentage of Episodes
|
|
Percentage of Episodes by Grade
Grade 2
|
23.3 Percentage of Episodes
|
27.2 Percentage of Episodes
|
|
Percentage of Episodes by Grade
Grade 3
|
11.3 Percentage of Episodes
|
5.9 Percentage of Episodes
|
|
Percentage of Episodes by Grade
Grade 4
|
0 Percentage of Episodes
|
0 Percentage of Episodes
|
SECONDARY outcome
Timeframe: 6 months overallPopulation: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient discontinued from the Octreotide LAR arm due to exclusion criteria after visit 1.
For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=67 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=71 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea
|
26.9 Percentage of participants
Interval 17.7 to 38.5
|
11.3 Percentage of participants
Interval 5.8 to 20.7
|
SECONDARY outcome
Timeframe: 6 months overallPopulation: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the "Octreotide Long Acting Release" Arm discontinued due to exclusion criteria after visit 1.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=67 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=71 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Percentage of Participants Who Need Opioids for Control of Diarrhea
|
1.5 Percentage of Participants
Interval 0.3 to 8.0
|
1.4 Percentage of Participants
Interval 0.2 to 7.6
|
SECONDARY outcome
Timeframe: 6 months overallPopulation: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the "Octreotide Long Acting Release" Arm discontinued due to exclusion criteria after visit 1.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=67 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=71 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Percentage of Patients Hospitalized Due to Diarrhea
|
6 Percentage of patients
|
4.2 Percentage of patients
|
SECONDARY outcome
Timeframe: 6 months overallPopulation: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the "Octreotide Long Acting Release" Arm discontinued due to exclusion criteria after visit 1.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=67 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=71 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea
|
4.5 Percentage of Participants
Interval 1.5 to 12.4
|
7.0 Percentage of Participants
Interval 3.0 to 15.4
|
SECONDARY outcome
Timeframe: Day 56, Day 84, Day 112, Day 140, Day 168Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. "N" in each category indicates the number of patients analyzed with observations at that timepoint.
Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as \> 20 mm with conventional techniques (CT, MRI) or as \> 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=68 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=71 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)
Day 56 (N=11,2)
|
45.5 Percentage of Participants
Interval 21.3 to 72.0
|
0.0 Percentage of Participants
Interval 0.0 to 65.8
|
|
Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)
Day 84 (N=5,3)
|
60.0 Percentage of Participants
Interval 23.1 to 88.2
|
100 Percentage of Participants
Interval 43.8 to 100.0
|
|
Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)
Day 112 (N=1,1)
|
100 Percentage of Participants
Interval 20.7 to 100.0
|
0.0 Percentage of Participants
Interval 0.0 to 79.3
|
|
Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)
Day 140 (N=9,1)
|
44.4 Percentage of Participants
Interval 18.9 to 73.3
|
100 Percentage of Participants
Interval 20.7 to 100.0
|
|
Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)
Day 168 (N=2,1)
|
100 Percentage of Participants
Interval 34.2 to 100.0
|
100 Percentage of Participants
Interval 20.7 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to Day 168Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.
Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point.
Outcome measures
| Measure |
Octreotide Long Acting Release
n=68 Participants
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
|
Standard Treatment
n=71 Participants
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
|
|---|---|---|
|
Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D)
|
0.5 Units on a scale
Standard Deviation 1.9
|
3.4 Units on a scale
Standard Deviation 2.0
|
Adverse Events
Octreotide LAR
Standard Treatment
Serious adverse events
| Measure |
Octreotide LAR
n=68 participants at risk
|
Standard Treatment
n=71 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/68
|
0.00%
0/71
|
|
Cardiac disorders
Cardiac failure congestiv
|
0.00%
0/68
|
1.4%
1/71
|
|
Endocrine disorders
Diabetes mellitus
|
0.00%
0/68
|
1.4%
1/71
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/68
|
1.4%
1/71
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/68
|
1.4%
1/71
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
5/68
|
5.6%
4/71
|
|
Gastrointestinal disorders
Gastrointestinal obstruct
|
2.9%
2/68
|
2.8%
2/71
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/68
|
1.4%
1/71
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/68
|
0.00%
0/71
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/68
|
1.4%
1/71
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/68
|
1.4%
1/71
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/68
|
1.4%
1/71
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/68
|
1.4%
1/71
|
|
General disorders
Mucosal inflammation
|
1.5%
1/68
|
0.00%
0/71
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/68
|
0.00%
0/71
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/68
|
2.8%
2/71
|
|
Investigations
Blood alkaline phosphatas
|
0.00%
0/68
|
1.4%
1/71
|
|
Investigations
International normalised
|
1.5%
1/68
|
0.00%
0/71
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/68
|
1.4%
1/71
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/68
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
2.9%
2/68
|
0.00%
0/71
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
|
1.5%
1/68
|
0.00%
0/71
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/68
|
2.8%
2/71
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/68
|
1.4%
1/71
|
|
Vascular disorders
Arterial occlusive diseas
|
0.00%
0/68
|
1.4%
1/71
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/68
|
1.4%
1/71
|
Other adverse events
| Measure |
Octreotide LAR
n=68 participants at risk
|
Standard Treatment
n=71 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.1%
15/68
|
15.5%
11/71
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.2%
11/68
|
23.9%
17/71
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.3%
7/68
|
11.3%
8/71
|
|
Endocrine disorders
Diabetes mellitus
|
5.9%
4/68
|
4.2%
3/71
|
|
Endocrine disorders
Hypothyroidism
|
7.4%
5/68
|
2.8%
2/71
|
|
Eye disorders
Lacrimation increased
|
2.9%
2/68
|
7.0%
5/71
|
|
Gastrointestinal disorders
Abdominal distension
|
8.8%
6/68
|
8.5%
6/71
|
|
Gastrointestinal disorders
Abdominal pain
|
27.9%
19/68
|
32.4%
23/71
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.8%
6/68
|
8.5%
6/71
|
|
Gastrointestinal disorders
Constipation
|
10.3%
7/68
|
5.6%
4/71
|
|
Gastrointestinal disorders
Diarrhoea
|
79.4%
54/68
|
78.9%
56/71
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/68
|
8.5%
6/71
|
|
Gastrointestinal disorders
Gastritis
|
8.8%
6/68
|
1.4%
1/71
|
|
Gastrointestinal disorders
Nausea
|
48.5%
33/68
|
64.8%
46/71
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
20/68
|
22.5%
16/71
|
|
General disorders
Asthenia
|
16.2%
11/68
|
16.9%
12/71
|
|
General disorders
Fatigue
|
5.9%
4/68
|
5.6%
4/71
|
|
General disorders
Mucosal inflammation
|
10.3%
7/68
|
4.2%
3/71
|
|
General disorders
Mucositis
|
17.6%
12/68
|
28.2%
20/71
|
|
General disorders
Oedema peripheral
|
8.8%
6/68
|
7.0%
5/71
|
|
General disorders
Pain
|
11.8%
8/68
|
1.4%
1/71
|
|
General disorders
Pyrexia
|
13.2%
9/68
|
15.5%
11/71
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.9%
4/68
|
0.00%
0/71
|
|
Infections and infestations
Influenza
|
8.8%
6/68
|
15.5%
11/71
|
|
Investigations
Blood alkaline phosphatas
|
2.9%
2/68
|
7.0%
5/71
|
|
Investigations
Gamma-glutamyltransferase
|
8.8%
6/68
|
8.5%
6/71
|
|
Investigations
Weight decreased
|
7.4%
5/68
|
2.8%
2/71
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
17/68
|
19.7%
14/71
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
4/68
|
8.5%
6/71
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.3%
7/68
|
7.0%
5/71
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.2%
9/68
|
12.7%
9/71
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
3/68
|
11.3%
8/71
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
1/68
|
5.6%
4/71
|
|
Nervous system disorders
Dizziness
|
8.8%
6/68
|
2.8%
2/71
|
|
Nervous system disorders
Headache
|
16.2%
11/68
|
16.9%
12/71
|
|
Nervous system disorders
Neuropathy peripheral
|
26.5%
18/68
|
29.6%
21/71
|
|
Nervous system disorders
Paraesthesia
|
10.3%
7/68
|
7.0%
5/71
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/68
|
7.0%
5/71
|
|
Psychiatric disorders
Insomnia
|
8.8%
6/68
|
9.9%
7/71
|
|
Renal and urinary disorders
Dysuria
|
1.5%
1/68
|
7.0%
5/71
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/68
|
7.0%
5/71
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/68
|
5.6%
4/71
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
4.4%
3/68
|
5.6%
4/71
|
|
Vascular disorders
Hypertension
|
7.4%
5/68
|
7.0%
5/71
|
|
Vascular disorders
Hypotension
|
1.5%
1/68
|
5.6%
4/71
|
Additional Information
Study Director
Novartis
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.
- Publication restrictions are in place
Restriction type: OTHER