Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer (NCT NCT02748213)
NCT ID: NCT02748213
Last Updated: 2016-11-22
Results Overview
Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
225 participants
Primary outcome timeframe
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Results posted on
2016-11-22
Participant Flow
Participant milestones
| Measure |
Herceptin + Taxotere + Xeloda
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m\^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
112
|
|
Overall Study
Treated
|
112
|
110
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
113
|
112
|
Reasons for withdrawal
| Measure |
Herceptin + Taxotere + Xeloda
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m\^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Overall Study
Withdrawal Prior to Treatment
|
1
|
2
|
|
Overall Study
Abnormal Laboratory Test
|
1
|
0
|
|
Overall Study
Adverse Event or Intercurrent Illness
|
5
|
11
|
|
Overall Study
Death
|
5
|
3
|
|
Overall Study
Insufficient Therapeutic Response
|
56
|
57
|
|
Overall Study
Violation of Selection Criteria
|
2
|
0
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Refused Treatment*
|
6
|
6
|
|
Overall Study
Failure to Return
|
1
|
0
|
|
Overall Study
Other
|
30
|
29
|
Baseline Characteristics
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Herceptin + Taxotere + Xeloda
n=112 Participants
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=110 Participants
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 10.74 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)Population: Full Analysis Set (FAS) Population.
Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.
Outcome measures
| Measure |
Herceptin + Taxotere + Xeloda
n=112 Participants
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=110 Participants
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
|
70.5 percentage of participants
Interval 61.18 to 78.77
|
72.7 percentage of participants
Interval 63.41 to 80.78
|
SECONDARY outcome
Timeframe: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)Population: FAS Population.
Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.
Outcome measures
| Measure |
Herceptin + Taxotere + Xeloda
n=112 Participants
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=110 Participants
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Percentage of Participants With Death or Disease Progression According to RECIST
|
67.9 percentage of participants
|
77.3 percentage of participants
|
SECONDARY outcome
Timeframe: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)Population: FAS Population.
Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Outcome measures
| Measure |
Herceptin + Taxotere + Xeloda
n=112 Participants
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=110 Participants
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Progression-Free Survival (PFS) According to RECIST
|
17.9 months
Interval 14.0 to 21.0
|
12.8 months
Interval 10.0 to 16.0
|
SECONDARY outcome
Timeframe: Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)Population: FAS Population.
The percentage of participants who died from any cause was reported.
Outcome measures
| Measure |
Herceptin + Taxotere + Xeloda
n=112 Participants
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=110 Participants
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Percentage of Participants Who Died
|
35.7 percentage of participants
|
41.8 percentage of participants
|
SECONDARY outcome
Timeframe: Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)Population: FAS Population.
OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Outcome measures
| Measure |
Herceptin + Taxotere + Xeloda
n=112 Participants
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=110 Participants
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
43.5 months
Interval 40.0 to 50.0
|
47.3 months
Interval 32.0 to
The upper limit of the 95% CI was not reached due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)Population: FAS Population. The "Number of Participants Analyzed" reflects the number of participants with a best overall response of CR or PR who provided evaluable data for the analysis.
Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.
Outcome measures
| Measure |
Herceptin + Taxotere + Xeloda
n=78 Participants
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=80 Participants
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Duration of Response (DOR) According to RECIST
|
15.9 months
Interval 2.4 to 64.7
|
13.4 months
Interval 2.1 to 55.1
|
Adverse Events
Herceptin + Taxotere + Xeloda
Serious events: 52 serious events
Other events: 112 other events
Deaths: 0 deaths
Herceptin + Taxotere
Serious events: 51 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Herceptin + Taxotere + Xeloda
n=112 participants at risk
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=110 participants at risk
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
16/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
23.6%
26/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
7/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
6.4%
7/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Neutropenic sepsis
|
4.5%
5/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Bronchopneumonia
|
2.7%
3/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Central line infection
|
1.8%
2/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
1.8%
2/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Oral candidiasis
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Tuberculosis
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
2.7%
3/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
3.6%
4/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Hyperthermia
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Inflammation of wound
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Pitting oedema
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
2.7%
3/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
5/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
3/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Jaundice
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
2.7%
3/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Diplegia
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Vascular disorders
Haemorrhage
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Vascular disorders
Thrombophlebitis
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukemia
|
0.00%
0/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Psychiatric disorders
Neurosis
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.89%
1/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.00%
0/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
Other adverse events
| Measure |
Herceptin + Taxotere + Xeloda
n=112 participants at risk
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m\^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
|
Herceptin + Taxotere
n=110 participants at risk
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m\^2, with adjustments allowed only for toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
67.0%
75/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
50.0%
55/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
54.5%
61/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
35.5%
39/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
33.0%
37/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
27.3%
30/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
25.9%
29/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
20.9%
23/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
25.9%
29/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
17.3%
19/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.3%
25/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
14.5%
16/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
19.6%
22/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
10.9%
12/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.6%
13/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
4.5%
5/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
3.6%
4/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.1%
8/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Odynophagia
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
67.9%
76/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
61.8%
68/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
50.9%
57/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
6.4%
7/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
25.0%
28/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
18.2%
20/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.6%
22/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
16.4%
18/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
17.9%
20/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
12.7%
14/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.6%
13/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
9.1%
10/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
13.4%
15/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
3.6%
4/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
8/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
7.3%
8/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
9/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
5.5%
6/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.9%
10/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
2.7%
3/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
3.6%
4/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
5.5%
6/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
1.8%
2/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
31.2%
35/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
31.8%
35/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
25.0%
28/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
38.2%
42/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
31.2%
35/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
26.4%
29/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Mucosal inflammation
|
30.4%
34/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
27.3%
30/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
22.3%
25/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
17.3%
19/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Chest pain
|
8.0%
9/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
9.1%
10/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Chills
|
8.9%
10/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
8.2%
9/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Oedema
|
2.7%
3/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
13.6%
15/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
General disorders
Pain
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
7.3%
8/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
17.9%
20/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
25.5%
28/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
9.8%
11/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
18.2%
20/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
10.7%
12/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
14.5%
16/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
15.2%
17/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
10.0%
11/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
11.6%
13/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
12.7%
14/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.9%
10/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
11.8%
13/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Neuropathy
|
9.8%
11/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
10.0%
11/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Lethargy
|
7.1%
8/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
11.8%
13/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Nervous system disorders
Neurotoxicity
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
4.5%
5/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
28/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
25.5%
28/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.4%
15/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
34.5%
38/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
14/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
13.6%
15/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.4%
15/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
9.1%
10/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.9%
10/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
9.1%
10/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
9/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
10.0%
11/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
1.8%
2/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
20/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
16.4%
18/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.6%
13/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
17.3%
19/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.8%
11/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
11.8%
13/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.9%
10/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
6.4%
7/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.5%
5/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
8.2%
9/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
4.5%
5/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.2%
35/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
20.9%
23/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.4%
15/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
17.3%
19/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.9%
10/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
9.1%
10/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
3/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
5.5%
6/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Eye disorders
Lacrimation increased
|
22.3%
25/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
20.0%
22/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Eye disorders
Conjunctivitis
|
13.4%
15/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
12.7%
14/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Eye disorders
Dry eye
|
6.2%
7/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
6.4%
7/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Eye disorders
Vision blurred
|
2.7%
3/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
5.5%
6/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
13.4%
15/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
10.9%
12/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Rhinitis
|
11.6%
13/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
10.0%
11/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
11.6%
13/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
9.1%
10/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
8/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
10.0%
11/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Vascular disorders
Hot flush
|
8.0%
9/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
12.7%
14/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Vascular disorders
Lymphoedema
|
7.1%
8/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
11.8%
13/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Vascular disorders
Phlebitis
|
5.4%
6/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
3.6%
4/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.5%
23/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
17.3%
19/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
8.9%
10/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
10.9%
12/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
3.6%
4/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
9.1%
10/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
3.6%
4/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
7.3%
8/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
7.1%
8/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
5.5%
6/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
|
Investigations
Weight decreased
|
6.2%
7/112 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
0.91%
1/110 • Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
|
Additional Information
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