Trial Outcomes & Findings for BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC) (NCT NCT00101413)
NCT ID: NCT00101413
Last Updated: 2013-10-30
Results Overview
CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- \>=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- \>=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- \>clinically meaningful cancer-related deterioration as judged by the investigator.
COMPLETED
PHASE2
52 participants
First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.
2013-10-30
Participant Flow
Study conducted in Germany and USA (1 center each) from Apr 2004 to Jun 2005. Recruitment in 2 phases: Interim analysis (IA) to be performed after treatment of 29 patients; final analysis planned after additional 21 patients. Final analysis data cut-off date 30 Jun 2005; safety data collected for the 4 ongoing subjects until 11 Apr 2008.
52 of 54 enrolled patients started treatment. The analysis population consisted of 52 subjects for the intent to treat (ITT) and safety analyses and 51 subjects in the evaluable subject analysis (1 had lung metastases from pancreatic cancer).
Participant milestones
| Measure |
Sorafenib
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)
Baseline characteristics by cohort
| Measure |
Sorafenib
n=52 Participants
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Age Continuous
|
62 years
n=5 Participants
|
|
Age, Customized
>=65 years
|
21 participants
n=5 Participants
|
|
Age, Customized
< 65 years
|
31 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma NSCLC
|
28 participants
n=5 Participants
|
|
Histology
Large cell carcinoma
|
4 participants
n=5 Participants
|
|
Histology
Squamous cell (epidermoid) carcinoma
|
16 participants
n=5 Participants
|
|
Histology
Undifferentiated carcinoma
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.Population: The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.
CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- \>=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- \>=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- \>clinically meaningful cancer-related deterioration as judged by the investigator.
Outcome measures
| Measure |
Sorafenib
n=51 Participants
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
Partial response
|
0.0 percentage of participants
|
|
Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
Progression by clinical judgement
|
11.8 percentage of participants
|
|
Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
Not evaluated
|
5.9 percentage of participants
|
|
Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
Stable disease
|
58.8 percentage of participants
|
|
Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
Progressive disease measurement proven
|
23.5 percentage of participants
|
|
Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
Complete response + Partial response
|
0.0 percentage of participants
|
|
Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
Complete response
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.Population: The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.
Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.
Outcome measures
| Measure |
Sorafenib
n=48 Participants
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Duration of Stable Disease
|
103 days
Interval 58.0 to 116.0
|
SECONDARY outcome
Timeframe: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks.Population: The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.
Overall survival was calculated from the date of the first treatment until death of the subject. Evaluation by Kaplan-Meier methodology, descriptive analysis.
Outcome measures
| Measure |
Sorafenib
n=51 Participants
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Overall Survival
|
205 days
Interval 151.0 to 257.0
|
SECONDARY outcome
Timeframe: First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.Population: The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.
Percentage of subjects with stable disease was calculated from date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Descriptive summary of subjects with SD.
Outcome measures
| Measure |
Sorafenib
n=51 Participants
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Percentage of Subjects With Stable Disease (SD)
|
58.8 Percentage of participants
|
SECONDARY outcome
Timeframe: From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatmentPopulation: The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.
HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.
Outcome measures
| Measure |
Sorafenib
n=50 Participants
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)
Cycle 4
|
0.0 scores on a scale
Standard Deviation 14.4
|
|
Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)
Cycle 2
|
-4.8 scores on a scale
Standard Deviation 21.2
|
|
Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)
End of treatment
|
-14.9 scores on a scale
Standard Deviation 23.2
|
Adverse Events
Sorafenib
Serious adverse events
| Measure |
Sorafenib
n=52 participants at risk
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Blood and lymphatic system disorders
Platelets
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Cardiac disorders
Cardiac arrythmia - other
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Cardiac disorders
Cardiac general - other
|
11.5%
6/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Cardiac disorders
Hypertension
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Cardiac disorders
Hypotension
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Death not associated with ctcae term, disease progression nos
|
11.5%
6/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Fatigue
|
9.6%
5/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Constitutional symptoms - other
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Anorexia
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Fistula, GI, esophagus
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
GI - other
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Stricture, GI,
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Vascular disorders
Hemorrhage, GI, upper GI nos
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Vascular disorders
Hemorrhage pulmonary, respiratory tract nos
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Hepatobiliary disorders
Hepatobiliary -other
|
3.8%
2/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Hepatobiliary disorders
Pancreatitis
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Infections and infestations
Infection (documented clinically), lung pneumonia
|
3.8%
2/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Blood and lymphatic system disorders
Dermal change
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Blood and lymphatic system disorders
Edema: limb
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Bilirubin
|
3.8%
2/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Amylase
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Lipase
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Metabolic/lab - other
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
CNS ischemia
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Confusion
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Mental status
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Neurology - other
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Somnolence
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Pain, abdomen nos
|
3.8%
2/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, chest/thorax nos
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, head/headache
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, other
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, neck
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Pain, stomach
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
4/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
2/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Fistula, pulmonary, bronchus
|
1.9%
1/52 • AE data were collected from Apr 2004 to Apr 2008
|
Other adverse events
| Measure |
Sorafenib
n=52 participants at risk
Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
|
|---|---|
|
Cardiac disorders
Hypertension
|
25.0%
13/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Fatigue
|
61.5%
32/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Weight loss
|
30.8%
16/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Fever
|
23.1%
12/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
36.5%
19/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Skin and subcutaneous tissue disorders
Dermatology - other
|
26.9%
14/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
13/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.1%
12/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
21.2%
11/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Diarrhea
|
51.9%
27/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Anorexia
|
34.6%
18/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Nausea
|
36.5%
19/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
11/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Infections and infestations
Infection - other
|
23.1%
12/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Blood and lymphatic system disorders
Dermal change
|
26.9%
14/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, other
|
36.5%
19/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, chest/thorax nos
|
26.9%
14/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, head/headache
|
26.9%
14/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, back
|
21.2%
11/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, abdomen nos
|
21.2%
11/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
51.9%
27/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.2%
23/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - other
|
23.1%
12/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Cardiac disorders
Hypotension
|
9.6%
5/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Cardiac disorders
Cardiac general - other
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.2%
10/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Insomnia
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Constitutional symptoms - other
|
19.2%
10/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Rigors/chills
|
9.6%
5/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Sweating
|
13.5%
7/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Constipation
|
11.5%
6/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
4/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Heartburn
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
Mucositis (clinical exam), oral cavitiy
|
11.5%
6/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Gastrointestinal disorders
GI - other
|
15.4%
8/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Vascular disorders
Hemorrhage - other
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Vascular disorders
Hemorrhage pulmonary, bronchopulmonary NOS
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Vascular disorders
Hemorrhage pulmonary, nose
|
7.7%
4/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - other
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Musculoskeletal and connective tissue disorders
Gait/walking
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
AST
|
7.7%
4/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Creatinine
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Lipase
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Metabolism and nutrition disorders
Metabolic/lab - other
|
11.5%
6/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Mood alteration, anxiety
|
7.7%
4/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Dizziness
|
15.4%
8/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Mood alteration, depression
|
11.5%
6/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Neurology - other
|
15.4%
8/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Nervous system disorders
Neuropathy - sensory
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Eye disorders
Ocular - other
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, chest wall
|
9.6%
5/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, extremity - limb
|
19.2%
10/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, tumor pain
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, joint
|
11.5%
6/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, muscle
|
9.6%
5/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, bone
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, neck
|
15.4%
8/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, stomach
|
17.3%
9/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
General disorders
Pain, throat/pharynx/larynx
|
7.7%
4/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
11.5%
6/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Renal and urinary disorders
Urinary frequency
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
|
Renal and urinary disorders
Renal - other
|
5.8%
3/52 • AE data were collected from Apr 2004 to Apr 2008
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60