Trial Outcomes & Findings for GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma (NCT NCT00244764)
NCT ID: NCT00244764
Last Updated: 2017-03-27
Results Overview
The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a \>=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
225 participants
Primary outcome timeframe
Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.
Results posted on
2017-03-27
Participant Flow
This study was originally designed as a Phase II, multi-centre study utilizing a randomized discontinuation design. In the original study design, a 12-week Lead-in Phase was an open-label period during which all enrolled participans received pazopanib.
All participants began with 12 weeks of open-label treatment. In the original design, participants with stable disease at Week 12 were to be randomized. After the interim analysis, the study was amended to be treated like a single-arm open-label study. Any participants who had been randomized to placebo were to be crossed back to pazopanib.
Participant milestones
| Measure |
Pazopanib 800 mg
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Overall Study
STARTED
|
225
|
|
Overall Study
COMPLETED
|
129
|
|
Overall Study
NOT COMPLETED
|
96
|
Reasons for withdrawal
| Measure |
Pazopanib 800 mg
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Overall Study
Adverse Event
|
37
|
|
Overall Study
Lost to Follow-up
|
23
|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Disease Progression
|
13
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Off Study Medication for >21 Days
|
1
|
|
Overall Study
Declining Performance Status
|
1
|
|
Overall Study
Participant was Hospitalized until Death
|
1
|
|
Overall Study
Primary Investigator Discretion
|
2
|
|
Overall Study
Sponsor Terminated Study
|
2
|
|
Overall Study
Developed Secondary Malignancy
|
1
|
Baseline Characteristics
GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Pazopanib 800 mg
n=225 Participants
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
178 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese/East Asian/South East Asian HER
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage (HER)
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native and White
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Mixed Asian Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.Population: All Enrolled: all participants who received at least one dose of pazopanib
The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a \>=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.
Outcome measures
| Measure |
Pazopanib 800 mg
n=225 Participants
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Overall Response by RECIST Criteria
Complete Response
|
3 participants
|
|
Overall Response by RECIST Criteria
Partial Response
|
75 participants
|
|
Overall Response by RECIST Criteria
Stable Disease
|
101 participants
|
|
Overall Response by RECIST Criteria
Progressive Disease
|
24 participants
|
|
Overall Response by RECIST Criteria
Not evaluable
|
22 participants
|
|
Overall Response by RECIST Criteria
Complete Response + Partial Response
|
78 participants
|
PRIMARY outcome
Timeframe: Week 12Population: Subset of the All Enrolled Population including only the first 60 participants
The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.
Outcome measures
| Measure |
Pazopanib 800 mg
n=60 Participants
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants
Complete Response
|
0 participants
|
|
Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants
Partial Response
|
23 participants
|
|
Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants
Stable Disease
|
25 participants
|
|
Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants
Progressive Disease
|
3 participants
|
|
Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants
Unknown
|
9 participants
|
SECONDARY outcome
Timeframe: First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.Population: All participants in the Enrolled Population who had a CR or PR
Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.
Outcome measures
| Measure |
Pazopanib 800 mg
n=78 Participants
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Duration of Response
|
68 weeks
Interval 53.7 to
There were too few responses with a known end date to calculate the upper bound of the 95% confidence interval.
|
SECONDARY outcome
Timeframe: From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)Population: All Enrolled Population. Participants who did not progress or die were censored at their last radiologic assessment.
Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a \>=20% increase in target lesions.
Outcome measures
| Measure |
Pazopanib 800 mg
n=225 Participants
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Progression-free Survival
|
45.3 weeks
Interval 36.0 to 59.1
|
Adverse Events
Pazopanib 800 mg
Serious events: 80 serious events
Other events: 215 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pazopanib 800 mg
n=225 participants at risk
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
3/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Diarrhhoea
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
3/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Ascites
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Constipation
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Faecaloma
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Ileal perforation
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
6/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
5/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
3/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
3/225 • Until participant was off study, approximately 7.84 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Chest pain
|
1.8%
4/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Fatigue
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
General physical health deterioration
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Oedema peripheral
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Dizziness
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Nerve root compression
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
3/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Body temperature increased
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Lipase increased
|
1.3%
3/225 • Until participant was off study, approximately 7.84 years
|
|
Infections and infestations
Anal abscess
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Infections and infestations
Gastroenteritis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Infections and infestations
Infection
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Infections and infestations
Wound infection
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Cardiac disorders
Myocardial infarction
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Cardiac disorders
Ventricular fibrillation
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Hepatobiliary disorders
Bile duct stone
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Hepatobiliary disorders
Jaundice
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Vascular disorders
Hypertension
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Vascular disorders
Haematoma
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioblastoma
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Psychiatric disorders
Confusional state
|
0.89%
2/225 • Until participant was off study, approximately 7.84 years
|
|
Psychiatric disorders
Depression
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Eye disorders
Retinal tear
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Headache
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Blood creatinine increased
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Blood urea increased
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Ejection fraction decreased
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Infections and infestations
Cellulitis
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Renal and urinary disorders
Haematuria
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Renal and urinary disorders
Proteinuria
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
0.44%
1/225 • Until participant was off study, approximately 7.84 years
|
Other adverse events
| Measure |
Pazopanib 800 mg
n=225 participants at risk
Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
65.8%
148/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Nausea
|
44.0%
99/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
50/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.4%
37/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Constipation
|
16.4%
37/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
25/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
14/225 • Until participant was off study, approximately 7.84 years
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
44.4%
100/225 • Until participant was off study, approximately 7.84 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.4%
37/225 • Until participant was off study, approximately 7.84 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.1%
25/225 • Until participant was off study, approximately 7.84 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.6%
26/225 • Until participant was off study, approximately 7.84 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
6.2%
14/225 • Until participant was off study, approximately 7.84 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
14/225 • Until participant was off study, approximately 7.84 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
12/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Fatigue
|
48.0%
108/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Oedema peripheral
|
8.9%
20/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Dysgeusia
|
25.3%
57/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Headache
|
20.9%
47/225 • Until participant was off study, approximately 7.84 years
|
|
Nervous system disorders
Dizziness
|
13.8%
31/225 • Until participant was off study, approximately 7.84 years
|
|
Vascular disorders
Hypertension
|
44.0%
99/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
44/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.6%
26/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
25/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
12/225 • Until participant was off study, approximately 7.84 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
15/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.6%
35/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.4%
28/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
12/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.4%
19/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
20/225 • Until participant was off study, approximately 7.84 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
12/225 • Until participant was off study, approximately 7.84 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.7%
69/225 • Until participant was off study, approximately 7.84 years
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
22/225 • Until participant was off study, approximately 7.84 years
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
18/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Alanine aminotransferase increased
|
14.2%
32/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Aspartate aminotransferase increased
|
12.4%
28/225 • Until participant was off study, approximately 7.84 years
|
|
Investigations
Weight decreased
|
10.2%
23/225 • Until participant was off study, approximately 7.84 years
|
|
Psychiatric disorders
Insomnia
|
9.3%
21/225 • Until participant was off study, approximately 7.84 years
|
|
Psychiatric disorders
Anxiety
|
5.8%
13/225 • Until participant was off study, approximately 7.84 years
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
12/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
13/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Stomatitis
|
5.8%
13/225 • Until participant was off study, approximately 7.84 years
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
12/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Chest pain
|
7.1%
16/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Pyrexia
|
7.1%
16/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Asthenia
|
6.2%
14/225 • Until participant was off study, approximately 7.84 years
|
|
General disorders
Mucosal inflammation
|
5.3%
12/225 • Until participant was off study, approximately 7.84 years
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER