Trial Outcomes & Findings for A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer (NCT NCT00679211)
NCT ID: NCT00679211
Last Updated: 2017-03-31
Results Overview
Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions. PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions. The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled).
COMPLETED
PHASE2
110 participants
From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled).
2017-03-31
Participant Flow
Between 13 August 2008 and 2 April 2009, 110 patients from 44 study sites in the United States were enrolled and treated in the study.
Participant milestones
| Measure |
Trastuzumab Emtansine
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
110
|
Reasons for withdrawal
| Measure |
Trastuzumab Emtansine
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|
|
Overall Study
Progressive disease
|
82
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Refused to undergo protocol procedures
|
1
|
|
Overall Study
Transferred to extension study TDM4529g
|
12
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab Emtansine
n=110 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled).Population: Treated population (patients who received at least one dose of T-DM1). Participants without a post-baseline tumor assessment were considered to be non-responders.
Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions. PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions. The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled).
Outcome measures
| Measure |
6 Months of Follow-up
n=110 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
9 Months of Follow-up
n=110 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|---|
|
Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review
|
32.7 percentage of participants
Interval 24.1 to 42.1
|
32.7 percentage of participants
Interval 24.1 to 42.1
|
SECONDARY outcome
Timeframe: From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.Population: Participants with an objective response.
For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was assessed by the independent review facility. Disease progression was 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.
Outcome measures
| Measure |
6 Months of Follow-up
n=36 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
9 Months of Follow-up
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|---|
|
Duration of Objective Response as Assessed Through Independent Radiologic Review
|
NA months
Interval 4.6 to
The median duration of objective response was not reached due to a low number of events (defined as disease progression or death from any cause on study, whichever occurred first).
|
—
|
SECONDARY outcome
Timeframe: From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.Population: Treated population.
Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Disease progression was assessed by the independent review facility. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
Outcome measures
| Measure |
6 Months of Follow-up
n=110 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
9 Months of Follow-up
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|---|
|
Progression-free Survival as Assessed Through Independent Radiologic Review
|
6.9 months
Interval 4.2 to 9.5
|
—
|
SECONDARY outcome
Timeframe: From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.Population: Treated population. Participants without a post-baseline tumor assessment were considered to have experienced no clinical benefit.
Clinical benefit was defined as participants who achieved an objective response (confirmed complete or partial response) between randomization and 1 January 2010, or with stable disease at 6 months. Stable disease at 6 months was defined as participants who achieved at least stable disease based on tumor assessments by the independent review facility, and remained alive and progression-free at 6 months. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, and no new lesions and/or unequivocal progression of existing nontarget lesions. Response was assessed by the independent review facility.
Outcome measures
| Measure |
6 Months of Follow-up
n=110 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
9 Months of Follow-up
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review
|
48.2 percentage of participants
Interval 38.8 to 57.9
|
—
|
SECONDARY outcome
Timeframe: From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.Population: Treated population. Participants without a post-baseline tumor assessment were considered to be non-responders.
Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Response was assessed by the study Investigator. CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions. PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions.
Outcome measures
| Measure |
6 Months of Follow-up
n=110 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
9 Months of Follow-up
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|---|
|
Objective Response Based on Investigator Assessment
|
32.7 percentage of participants
Interval 24.1 to 42.1
|
—
|
SECONDARY outcome
Timeframe: From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.Population: Treated population
Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
Outcome measures
| Measure |
6 Months of Follow-up
n=110 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
9 Months of Follow-up
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|---|
|
Progression-free Survival Based on Investigator Assessment
|
5.5 months
Interval 4.1 to 7.5
|
—
|
SECONDARY outcome
Timeframe: From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.Population: Participants with an objective response.
For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was determined by the Investigator's assessment. Disease progression was 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.
Outcome measures
| Measure |
6 Months of Follow-up
n=36 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
9 Months of Follow-up
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|---|
|
Duration of Objective Response Based on Investigator Assessment
|
9.7 months
Interval 6.6 to
Upper limit of the confidence interval not reached due to low number of events (defined as disease progression or death from any cause on study, whichever occurred first).
|
—
|
SECONDARY outcome
Timeframe: From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.Population: Treated population. Patients without a post-baseline tumor assessment were considered to have experienced no clinical benefit.
Clinical benefit was defined as participants with an objective response (confirmed complete or partial response) or stable disease at 6 months. Patients with stable disease at 6 months were defined as patients who achieved at least stable disease based on tumor assessments and remained alive and progression free at 6 months. Response was based on the Investigator's assessment.
Outcome measures
| Measure |
6 Months of Follow-up
n=110 Participants
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
9 Months of Follow-up
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit Based on Investigator Assessment
|
46.4 percentage of participants
Interval 37.1 to 56.1
|
—
|
Adverse Events
Trastuzumab Emtansine
Serious adverse events
| Measure |
Trastuzumab Emtansine
n=110 participants at risk
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
2/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Pyrexia
|
2.7%
3/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Axillary pain
|
1.8%
2/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Chest pain
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Cellulitis
|
3.6%
4/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Pneumonia
|
2.7%
3/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Bacteraemia
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Herpes zoster
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Sepsis
|
1.8%
2/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Staphylococcal infection
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Wound infection
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Blood creatinine increased
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Blood culture positive
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Nervous system disorders
Convulsion
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Nervous system disorders
Spinal cord compression
|
1.8%
2/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Nervous system disorders
Central nervous system necrosis
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Psychiatric disorders
Confusional state
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Vascular disorders
Deep vein thrombosis
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Influenza like illness
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Gastroenteritis viral
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.91%
1/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
Other adverse events
| Measure |
Trastuzumab Emtansine
n=110 participants at risk
Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.6%
37/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.9%
23/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.5%
6/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Eye disorders
Lacrimation increased
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Eye disorders
Vision blurred
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Nausea
|
37.3%
41/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Constipation
|
24.5%
27/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
22/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
16.4%
18/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.7%
14/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
11/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
8/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.5%
6/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Fatigue
|
62.7%
69/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Pyrexia
|
21.8%
24/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Chills
|
10.0%
11/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Oedema peripheral
|
10.0%
11/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Pain
|
9.1%
10/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Chest pain
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
General disorders
Influenza like illness
|
5.5%
6/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
11/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
10/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Infections and infestations
Sinusitis
|
7.3%
8/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.6%
15/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
27.3%
30/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
14.5%
16/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.9%
12/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Weight decreased
|
10.9%
12/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Blood lactate dehydrogenase increase
|
9.1%
10/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Platelet count decreased
|
7.3%
8/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
Haemoglobin decreased
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Investigations
White blood cell count decreased
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.7%
25/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.9%
23/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.5%
6/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.2%
20/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.5%
16/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.5%
16/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
15/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.8%
13/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.3%
8/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Nervous system disorders
Headache
|
23.6%
26/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Nervous system disorders
Neuropathy peripheral
|
18.2%
20/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Nervous system disorders
Dysgeusia
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Nervous system disorders
Dizziness
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Psychiatric disorders
Depression
|
10.0%
11/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Psychiatric disorders
Anxiety
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Psychiatric disorders
Insomnia
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Reproductive system and breast disorders
Breast pain
|
5.5%
6/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.7%
25/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.1%
21/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.5%
17/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.2%
9/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Vascular disorders
Hot flush
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Vascular disorders
Lymphoedema
|
6.4%
7/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
|
Vascular disorders
Hypertension
|
5.5%
6/110 • From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
|
Additional Information
Medical Communications
Genentech, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER