Trial Outcomes & Findings for BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy. (NCT NCT01658436)
NCT ID: NCT01658436
Last Updated: 2016-05-02
Results Overview
PFS rate at 16 weeks was defined as a binary variable. Patients were considered as 'progression free' after 16 weeks if they had an overall lesion response of complete response (CR) partial response ('PR) or stable disease (SD)' and "progressed" if they had an overall lesion response of 'Progressive disease (PD) at the scan which occurred on day 105 after start of treatment, or later. Patients whose 16 weeks tumor assessment was unknown, missing or outside the window was not considered as 'progression free' and was considered a "failure" and counted only in the denominator for the estimation of the 16 week progression free rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
16 weeks after the first BEZ235 administration.
Results posted on
2016-05-02
Participant Flow
This was a Phase II, two-stage, multicenter study, where Stage 1 was a singlearm,open label design and Stage 2 was planned to be a randomized, double-blind study. However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.
Initially , the patients were started at BEZ235 400mg bid dose regimen. The preliminary safety \& tolerability data fro first 3 patients treated at this dose showed all patients reported AEs leading to dose interruption. It was decided to decrease the dose of BEZ235 to 300mg bid dose regimen.
Participant milestones
| Measure |
BEZ235 300 mg
Oral BEZ235 300 mg bid was investigated in stage 1 of study
|
BEZ235 400 mg Bid
Oral BEZ235 400 mg bid was investigated in stage 1 of study
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
11
|
Reasons for withdrawal
| Measure |
BEZ235 300 mg
Oral BEZ235 300 mg bid was investigated in stage 1 of study
|
BEZ235 400 mg Bid
Oral BEZ235 400 mg bid was investigated in stage 1 of study
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Progressive disease
|
12
|
4
|
|
Overall Study
Study terminated by sponsor
|
0
|
1
|
|
Overall Study
Subject/guardian decision
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
Baseline characteristics by cohort
| Measure |
BEZ235 300 mg/400 mg Bid
n=31 Participants
Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
|
|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks after the first BEZ235 administration.Population: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as 'Analysis Set Stage 1' (AS1).
PFS rate at 16 weeks was defined as a binary variable. Patients were considered as 'progression free' after 16 weeks if they had an overall lesion response of complete response (CR) partial response ('PR) or stable disease (SD)' and "progressed" if they had an overall lesion response of 'Progressive disease (PD) at the scan which occurred on day 105 after start of treatment, or later. Patients whose 16 weeks tumor assessment was unknown, missing or outside the window was not considered as 'progression free' and was considered a "failure" and counted only in the denominator for the estimation of the 16 week progression free rate.
Outcome measures
| Measure |
BEZ235 300 mg/400 mg Bid
n=31 Participants
Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
|
|---|---|
|
Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review
|
51.6 Percentage of participants
Interval 35.7 to 67.3
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to 31 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as 'Analysis Set Stage 1' (AS1).
Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.
Outcome measures
| Measure |
BEZ235 300 mg/400 mg Bid
n=31 Participants
Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
|
|---|---|
|
Stage 1- Overall Response Rate (ORR)
Partial response
|
0.0 Percentage of participants
|
|
Stage 1- Overall Response Rate (ORR)
Complete response
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to 31 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as 'Analysis Set Stage 1' (AS1).
Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.
Outcome measures
| Measure |
BEZ235 300 mg/400 mg Bid
n=31 Participants
Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
|
|---|---|
|
Stage 1 - Disease Control Rate
|
71.0 Percentage of participants
Interval 54.8 to 83.9
|
Adverse Events
BEZ235 300 mg Bid
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
BEZ235 400 mg Bid
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BEZ235 300 mg Bid
n=20 participants at risk
BEZ235 300 mg bid
|
BEZ235 400 mg Bid
n=11 participants at risk
BEZ235 400 mg bid
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Cardiac disorders
CARDIAC ARREST
|
5.0%
1/20
|
0.00%
0/11
|
|
Cardiac disorders
LEFT VENTRICULAR HYPERTROPHY
|
0.00%
0/20
|
9.1%
1/11
|
|
Cardiac disorders
SYSTOLIC DYSFUNCTION
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.0%
2/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
VOMITING
|
5.0%
1/20
|
0.00%
0/11
|
|
General disorders
PYREXIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.00%
0/20
|
9.1%
1/11
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
0.00%
0/20
|
9.1%
1/11
|
|
Infections and infestations
ERYSIPELAS
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
INFECTION
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
SEPSIS
|
10.0%
2/20
|
0.00%
0/11
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
5.0%
1/20
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
5.0%
1/20
|
0.00%
0/11
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/20
|
9.1%
1/11
|
Other adverse events
| Measure |
BEZ235 300 mg Bid
n=20 participants at risk
BEZ235 300 mg bid
|
BEZ235 400 mg Bid
n=11 participants at risk
BEZ235 400 mg bid
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/20
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/20
|
18.2%
2/11
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/20
|
9.1%
1/11
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
5.0%
1/20
|
0.00%
0/11
|
|
Cardiac disorders
CARDIAC FAILURE
|
5.0%
1/20
|
0.00%
0/11
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/20
|
9.1%
1/11
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
10.0%
2/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
30.0%
6/20
|
18.2%
2/11
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
10.0%
2/20
|
36.4%
4/11
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
ASCITES
|
5.0%
1/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.0%
4/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
DIARRHOEA
|
80.0%
16/20
|
54.5%
6/11
|
|
Gastrointestinal disorders
DRY MOUTH
|
10.0%
2/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.0%
2/20
|
18.2%
2/11
|
|
Gastrointestinal disorders
GASTROINTESTINAL MOTILITY DISORDER
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.0%
1/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
5.0%
1/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
MELAENA
|
5.0%
1/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
NAUSEA
|
45.0%
9/20
|
54.5%
6/11
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
5.0%
1/20
|
18.2%
2/11
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
STOMATITIS
|
30.0%
6/20
|
45.5%
5/11
|
|
Gastrointestinal disorders
TOOTH DISCOLOURATION
|
0.00%
0/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
VOMITING
|
30.0%
6/20
|
36.4%
4/11
|
|
General disorders
ASTHENIA
|
20.0%
4/20
|
27.3%
3/11
|
|
General disorders
FACE OEDEMA
|
5.0%
1/20
|
0.00%
0/11
|
|
General disorders
FATIGUE
|
35.0%
7/20
|
27.3%
3/11
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
10.0%
2/20
|
0.00%
0/11
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
5.0%
1/20
|
18.2%
2/11
|
|
General disorders
OEDEMA
|
0.00%
0/20
|
9.1%
1/11
|
|
General disorders
OEDEMA PERIPHERAL
|
20.0%
4/20
|
27.3%
3/11
|
|
General disorders
PAIN
|
0.00%
0/20
|
9.1%
1/11
|
|
General disorders
PYREXIA
|
20.0%
4/20
|
9.1%
1/11
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/20
|
9.1%
1/11
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
10.0%
2/20
|
9.1%
1/11
|
|
Hepatobiliary disorders
HYPERTRANSAMINASAEMIA
|
0.00%
0/20
|
18.2%
2/11
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
5.0%
1/20
|
0.00%
0/11
|
|
Immune system disorders
HYPERSENSITIVITY
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
BRONCHITIS
|
10.0%
2/20
|
0.00%
0/11
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/20
|
9.1%
1/11
|
|
Infections and infestations
FOLLICULITIS
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
GINGIVITIS
|
0.00%
0/20
|
9.1%
1/11
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/20
|
9.1%
1/11
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/20
|
9.1%
1/11
|
|
Infections and infestations
ORAL HERPES
|
5.0%
1/20
|
18.2%
2/11
|
|
Infections and infestations
PARONYCHIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/20
|
9.1%
1/11
|
|
Infections and infestations
RHINITIS
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.00%
0/20
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
CONTRAST MEDIA REACTION
|
5.0%
1/20
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
10.0%
2/20
|
0.00%
0/11
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
10.0%
2/20
|
0.00%
0/11
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/20
|
9.1%
1/11
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
BLOOD CREATININE INCREASED
|
5.0%
1/20
|
9.1%
1/11
|
|
Investigations
BLOOD IRON DECREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
BLOOD POTASSIUM INCREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
EJECTION FRACTION DECREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
15.0%
3/20
|
18.2%
2/11
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/20
|
9.1%
1/11
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
PLATELET COUNT DECREASED
|
5.0%
1/20
|
0.00%
0/11
|
|
Investigations
WEIGHT DECREASED
|
10.0%
2/20
|
18.2%
2/11
|
|
Investigations
WHITE BLOOD CELLS URINE
|
0.00%
0/20
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
30.0%
6/20
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/20
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
35.0%
7/20
|
36.4%
4/11
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
10.0%
2/20
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.0%
1/20
|
27.3%
3/11
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.0%
1/20
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
15.0%
3/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
5.0%
1/20
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
MUSCLE ATROPHY
|
5.0%
1/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
10.0%
2/20
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
5.0%
1/20
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.0%
1/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
15.0%
3/20
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
10.0%
2/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.0%
1/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.0%
1/20
|
0.00%
0/11
|
|
Nervous system disorders
DIZZINESS
|
5.0%
1/20
|
0.00%
0/11
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/20
|
9.1%
1/11
|
|
Nervous system disorders
HEADACHE
|
5.0%
1/20
|
0.00%
0/11
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/20
|
18.2%
2/11
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/20
|
9.1%
1/11
|
|
Nervous system disorders
MIGRAINE
|
5.0%
1/20
|
0.00%
0/11
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/20
|
9.1%
1/11
|
|
Nervous system disorders
TREMOR
|
5.0%
1/20
|
9.1%
1/11
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/20
|
9.1%
1/11
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/20
|
9.1%
1/11
|
|
Psychiatric disorders
DEPRESSION
|
5.0%
1/20
|
0.00%
0/11
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/20
|
9.1%
1/11
|
|
Psychiatric disorders
INSOMNIA
|
5.0%
1/20
|
9.1%
1/11
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
5.0%
1/20
|
0.00%
0/11
|
|
Renal and urinary disorders
DYSURIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/20
|
9.1%
1/11
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
5.0%
1/20
|
0.00%
0/11
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/20
|
9.1%
1/11
|
|
Reproductive system and breast disorders
VULVOVAGINAL DRYNESS
|
0.00%
0/20
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
CATARRH
|
0.00%
0/20
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
30.0%
6/20
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.0%
1/20
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/20
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.0%
1/20
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.0%
1/20
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
5.0%
1/20
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/20
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/20
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
5.0%
1/20
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
15.0%
3/20
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
HAND DERMATITIS
|
5.0%
1/20
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
5.0%
1/20
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
5.0%
1/20
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
NAIL TOXICITY
|
5.0%
1/20
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
5.0%
1/20
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
5.0%
1/20
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/20
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.0%
1/20
|
18.2%
2/11
|
|
Skin and subcutaneous tissue disorders
RASH
|
10.0%
2/20
|
27.3%
3/11
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/20
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
0.00%
0/20
|
9.1%
1/11
|
|
Vascular disorders
FLUSHING
|
0.00%
0/20
|
9.1%
1/11
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/20
|
9.1%
1/11
|
|
Vascular disorders
HYPERTENSION
|
15.0%
3/20
|
0.00%
0/11
|
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