Trial Outcomes & Findings for A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST) (NCT NCT01039519)
NCT ID: NCT01039519
Last Updated: 2016-03-10
Results Overview
Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks. * CR: disappearance of all target lesions and non-target lesions and no new lesions * PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions * SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Week 16 up to Week 47
Results posted on
2016-03-10
Participant Flow
Thirty-one patients were screened; 4 of the 31 were screen failures.
Participant milestones
| Measure |
Ganetespib 200 mg/m^2
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Treatment
STARTED
|
27
|
|
Treatment
COMPLETED
|
0
|
|
Treatment
NOT COMPLETED
|
27
|
|
Survival Follow-up
STARTED
|
27
|
|
Survival Follow-up
COMPLETED
|
0
|
|
Survival Follow-up
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Ganetespib 200 mg/m^2
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Treatment
Progressive disease
|
20
|
|
Treatment
Treatment failure
|
2
|
|
Treatment
Adverse Event
|
3
|
|
Treatment
Physician Decision
|
2
|
|
Survival Follow-up
Death
|
23
|
|
Survival Follow-up
Sponsor decision
|
4
|
Baseline Characteristics
A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
Baseline characteristics by cohort
| Measure |
Ganetespib 200 mg/m^2
n=27 Participants
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight
|
74.94 kg
STANDARD_DEVIATION 22.095 • n=5 Participants
|
|
Height
|
171.57 cm
STANDARD_DEVIATION 10.295 • n=5 Participants
|
|
Body Surface Area (BSA)
|
1.863 m^2
STANDARD_DEVIATION 0.2909 • n=5 Participants
|
|
Time from Initial Gastrointestinal Stromal Tumor (GIST) Diagnosis to Consent
|
68.71 months
STANDARD_DEVIATION 34.699 • n=5 Participants
|
|
Time from Metastatic/Unresectable GIST Diagnosis to Consent
|
46.77 months
STANDARD_DEVIATION 28.606 • n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
13 participants
n=5 Participants
|
|
Any Prior Exposure to Heat Shock Protein 90 (HSP90) Inhibitors
Yes
|
5 participants
n=5 Participants
|
|
Any Prior Exposure to Heat Shock Protein 90 (HSP90) Inhibitors
No
|
21 participants
n=5 Participants
|
|
Any Prior Exposure to Heat Shock Protein 90 (HSP90) Inhibitors
Unknown
|
1 participants
n=5 Participants
|
|
Prior Systemic Treatment for GIST
Yes
|
27 participants
n=5 Participants
|
|
Prior Systemic Treatment for GIST
No
|
0 participants
n=5 Participants
|
|
Number of Prior Systemic Treatment Regimens for GIST
|
5.85 regimens
STANDARD_DEVIATION 2.476 • n=5 Participants
|
|
Best Response From Prior Systemic Treatment
Complete response
|
3 participants
n=5 Participants
|
|
Best Response From Prior Systemic Treatment
Partial response
|
6 participants
n=5 Participants
|
|
Best Response From Prior Systemic Treatment
Stable Disease
|
17 participants
n=5 Participants
|
|
Best Response From Prior Systemic Treatment
Progressive disease
|
1 participants
n=5 Participants
|
|
Best Response From Prior Systemic Treatment
Unknown
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16 up to Week 47Population: Full analysis set which included participants receiving at least one dose of study medication.
Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks. * CR: disappearance of all target lesions and non-target lesions and no new lesions * PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions * SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions
Outcome measures
| Measure |
Ganetespib 200 mg/m^2
n=27 Participants
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
|
18.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16 up to Week 47Population: Full analysis set
Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study. * CR: disappearance of all target lesions and non-target lesions and no new lesions * PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions
Outcome measures
| Measure |
Ganetespib 200 mg/m^2
n=27 Participants
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 47Population: Full analysis set
PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as * at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or * the appearance of 1 or more new lesions or * the unequivocal progression of existing nontarget lesions
Outcome measures
| Measure |
Ganetespib 200 mg/m^2
n=27 Participants
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Kaplan-Meier Estimate of Progression Free Survival (PFS)
|
1.8 months
Interval 1.6 to 3.5
|
SECONDARY outcome
Timeframe: Day 1 up to week 97Population: Full analysis set
Overall survival was defined as the time from first dose to death or the date last known alive.
Outcome measures
| Measure |
Ganetespib 200 mg/m^2
n=27 Participants
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Kaplan-Meier Estimate of Overall Survival
|
10.3 months
Interval 5.8 to 13.6
|
SECONDARY outcome
Timeframe: Day 2 to Day 10Population: Participants from one investigative site who provided consent for the PET/CT imaging.
PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines \[Young H, Eur J Cancer, 1999\]. Tumor response was considered a complete response (CR) or a partial response (PR).
Outcome measures
| Measure |
Ganetespib 200 mg/m^2
n=12 Participants
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 51Population: Full analysis set
Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event. Dose modification includes dose delay and dose reduction.
Outcome measures
| Measure |
Ganetespib 200 mg/m^2
n=27 Participants
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Count of Participants With Treatment-Emergent Adverse Events (AEs)
>=1 AE with severity grade >=3
|
15 participants
|
|
Count of Participants With Treatment-Emergent Adverse Events (AEs)
>=1 AE
|
27 participants
|
|
Count of Participants With Treatment-Emergent Adverse Events (AEs)
>= 1 SAE
|
10 participants
|
|
Count of Participants With Treatment-Emergent Adverse Events (AEs)
>=1 AE leading to dose modification
|
10 participants
|
|
Count of Participants With Treatment-Emergent Adverse Events (AEs)
>=1 AE with an outcome of death
|
1 participants
|
|
Count of Participants With Treatment-Emergent Adverse Events (AEs)
>=1 AE leading to dose interruption
|
1 participants
|
|
Count of Participants With Treatment-Emergent Adverse Events (AEs)
>=1 AE leading to study drug discontinuation
|
3 participants
|
Adverse Events
Ganetespib 200 mg/m^2
Serious events: 10 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ganetespib 200 mg/m^2
n=27 participants at risk
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Colonic fistula
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Intussusception
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Hepatobiliary disorders
Hepatic pain
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Infection
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Amylase increased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Blood bilirubin increased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Lipase increased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Psychiatric disorders
Confusional state
|
3.7%
1/27 • Day 1 up to Week 51
|
Other adverse events
| Measure |
Ganetespib 200 mg/m^2
n=27 participants at risk
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
9/27 • Day 1 up to Week 51
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Cardiac disorders
Tachycardia
|
11.1%
3/27 • Day 1 up to Week 51
|
|
Cardiac disorders
Arrhythmia superventribular
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Ear and labyrinth disorders
Ear discomfort
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Eye disorders
Eye pain
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Eye disorders
Vision blurred
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Diarrhoea
|
81.5%
22/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Nausea
|
48.1%
13/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Vomiting
|
37.0%
10/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Constipation
|
25.9%
7/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Abdominal distension
|
22.2%
6/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Abdominal pain
|
18.5%
5/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Abdominal discomfort
|
14.8%
4/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Abdominal pain lower
|
14.8%
4/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Abdominal tenderness
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Retching
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Anal fissure
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Ascites
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Frequent bowel movements
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Haematochezia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Proctalgia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Gastrointestinal disorders
Stomatitis
|
3.7%
1/27 • Day 1 up to Week 51
|
|
General disorders
Fatigue
|
55.6%
15/27 • Day 1 up to Week 51
|
|
General disorders
Asthenia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
General disorders
Malaise
|
7.4%
2/27 • Day 1 up to Week 51
|
|
General disorders
Pyrexia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
General disorders
Chest pain
|
3.7%
1/27 • Day 1 up to Week 51
|
|
General disorders
Chills
|
3.7%
1/27 • Day 1 up to Week 51
|
|
General disorders
Early satiety
|
3.7%
1/27 • Day 1 up to Week 51
|
|
General disorders
Feeling jittery
|
3.7%
1/27 • Day 1 up to Week 51
|
|
General disorders
Influenza like illness
|
3.7%
1/27 • Day 1 up to Week 51
|
|
General disorders
Localised oedema
|
3.7%
1/27 • Day 1 up to Week 51
|
|
General disorders
Oedema
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Bronchitis
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Candidiasis
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Ear infection
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Eye infection bacterial
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Fungal skin infection
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Gastroenteritis viral
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Labyrinthitis
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
3/27 • Day 1 up to Week 51
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
3/27 • Day 1 up to Week 51
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Injury, poisoning and procedural complications
Compression fracture
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Injury, poisoning and procedural complications
Seroma
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Blood alkaline phosphatase increased
|
25.9%
7/27 • Day 1 up to Week 51
|
|
Investigations
Weight decreased
|
18.5%
5/27 • Day 1 up to Week 51
|
|
Investigations
Amylase increased
|
14.8%
4/27 • Day 1 up to Week 51
|
|
Investigations
Aspartate aminotransferase increased
|
14.8%
4/27 • Day 1 up to Week 51
|
|
Investigations
Lipase increased
|
14.8%
4/27 • Day 1 up to Week 51
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Investigations
Blood creatine phosphokinase increased
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Blood albumin decreased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Blood creatinine increased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Blood magnesium decreased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Blood phosphorus decreased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Blood potassium decreased
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Electrocardiogram QT prolonged
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.5%
5/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.5%
5/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
3/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Investigations
Hypertriglyceridaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Hypocalcaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Hypomagnesaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Investigations
Hypophosphataemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
6/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
6/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.5%
5/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Nervous system disorders
Headache
|
37.0%
10/27 • Day 1 up to Week 51
|
|
Nervous system disorders
Dizziness
|
14.8%
4/27 • Day 1 up to Week 51
|
|
Nervous system disorders
Presyncope
|
11.1%
3/27 • Day 1 up to Week 51
|
|
Nervous system disorders
Dysgeusia
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Nervous system disorders
Somnolence
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Nervous system disorders
Paraesthesia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Psychiatric disorders
Insomnia
|
29.6%
8/27 • Day 1 up to Week 51
|
|
Psychiatric disorders
Anxiety
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Psychiatric disorders
Confusional state
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Psychiatric disorders
Nightmare
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Psychiatric disorders
Abnormal dreams
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Psychiatric disorders
Agitation
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Psychiatric disorders
Depressed mood
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Renal and urinary disorders
Bladder pain
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Renal and urinary disorders
Fanconi syndrome acquired
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Renal and urinary disorders
Proteinuria
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Renal and urinary disorders
Urinary hesitation
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
4/27 • Day 1 up to Week 51
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
18.5%
5/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.4%
2/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Vascular disorders
Hypertension
|
14.8%
4/27 • Day 1 up to Week 51
|
|
Vascular disorders
Deep vein thrombosis
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Vascular disorders
Flushing
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Vascular disorders
Hot flush
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.7%
1/27 • Day 1 up to Week 51
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.7%
1/27 • Day 1 up to Week 51
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right, 60 days before submission for publication, to review disclosures and require deletion of its confidential information, excluding the study results. Public disclosure shall be delayed for up to 60 additional days in order for the Sponsor to file a patent application, if needed. Single center publications will be postponed until after disclosure of pooled data (all sites), or, for a period of 18 months from study completion/termination at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER