Trial Outcomes & Findings for Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery (NCT NCT00436566)
NCT ID: NCT00436566
Last Updated: 2022-08-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
6 months
Results posted on
2022-08-05
Participant Flow
One-hundred and twenty-two (122) participants were recruited between April 2007 and October 2008 at Mayo Clinic. Ten (10) participants were deemed ineligible due to HER-2+ not corroborated by the central laboratory evaluation. These 10 participants and 3 participants (those who did not completed the treatment) were excluded from all analysis.
Participant milestones
| Measure |
AC/PTL
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
109
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
AC/PTL
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
Baseline characteristics by cohort
| Measure |
AC/PTL
n=109 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
91 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
18 participants
n=5 Participants
|
|
T Stage
T1=Tumor <=2 cm (3/4 of an inch) across
|
43 participants
n=5 Participants
|
|
T Stage
T2=2cm < Tumor <5 cm across
|
58 participants
n=5 Participants
|
|
T Stage
T3=Tumor > 5 cm across
|
6 participants
n=5 Participants
|
|
T Stage
Missing
|
2 participants
n=5 Participants
|
|
Nodal Status
N0
|
49 participants
n=5 Participants
|
|
Nodal Status
N1
|
32 participants
n=5 Participants
|
|
Nodal Status
N2
|
12 participants
n=5 Participants
|
|
Nodal Status
N3
|
14 participants
n=5 Participants
|
|
Nodal Status
SLN+ without full axillary dissection
|
2 participants
n=5 Participants
|
|
Hormonal Status
Estrogen and/or Progesterone Positive
|
54 participants
n=5 Participants
|
|
Hormonal Status
Estrogen and Progesterone Negative
|
55 participants
n=5 Participants
|
|
HER2 Status - Positive
FISH Amp/IHC Pos
|
93 participants
n=5 Participants
|
|
HER2 Status - Positive
FISH Amp/IHC Neg
|
8 participants
n=5 Participants
|
|
HER2 Status - Positive
FISH Not Amp/IHC Pos
|
6 participants
n=5 Participants
|
|
HER2 Status - Positive
FISH Not Done/IHC Pos
|
2 participants
n=5 Participants
|
|
Left Ventricular Ejection Fraction (LVEF) Measurement
|
63.3 percentage
n=5 Participants
|
|
Smoking status
Never
|
60 participants
n=5 Participants
|
|
Smoking status
Former
|
24 participants
n=5 Participants
|
|
Smoking status
Current
|
25 participants
n=5 Participants
|
|
Current use of hypertensive medication
Yes
|
28 participants
n=5 Participants
|
|
Current use of hypertensive medication
No
|
81 participants
n=5 Participants
|
|
History of diabetes
Yes
|
10 participants
n=5 Participants
|
|
History of diabetes
No
|
99 participants
n=5 Participants
|
|
Menopausal status
Premenopausal
|
43 participants
n=5 Participants
|
|
Menopausal status
Perimenopausal
|
8 participants
n=5 Participants
|
|
Menopausal status
Postmenopausal
|
58 participants
n=5 Participants
|
|
Education level
Less than high school
|
3 participants
n=5 Participants
|
|
Education level
High school
|
35 participants
n=5 Participants
|
|
Education level
Beyond high school
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
AC/PTL
n=109 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment
|
0 participants
|
SECONDARY outcome
Timeframe: 5 yearsMeasured by number of patients with at least one with grade 3+, Grade 4+, Hem, and Non-Hem AEs.
Outcome measures
| Measure |
AC/PTL
n=109 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Adverse Event Profile as Measured by NCI CTCAE v 3.0
Grade 3+ Adverse Event
|
84 Participants
|
|
Adverse Event Profile as Measured by NCI CTCAE v 3.0
Grade 4+ Adverse Event
|
27 Participants
|
|
Adverse Event Profile as Measured by NCI CTCAE v 3.0
Grade 3+ Hem Adverse Event
|
33 Participants
|
|
Adverse Event Profile as Measured by NCI CTCAE v 3.0
Grade 4+ Hem Adverse Event
|
23 Participants
|
|
Adverse Event Profile as Measured by NCI CTCAE v 3.0
Grade 3+ Non-Hem Adverse Event
|
80 Participants
|
|
Adverse Event Profile as Measured by NCI CTCAE v 3.0
Grade 4+ Non-Hem Adverse Event
|
12 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 102 patients began post-AC therapy
Evaluable patients included those completed the AC phase of their treatment regimen; with post AC cardiac evaluation indicates they are eligible to begin treatment with PTL; and those have begun their post-AC therapy. Cardiac events: symptomatic congestive heart failure (CHF), cardiac death and other cardiac events (NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade \>=3)
Outcome measures
| Measure |
AC/PTL
n=102 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Cumulative Incidence (CI) of Cardiac Events
|
5 Post AC Cardiac Adverse Event
|
SECONDARY outcome
Timeframe: 5 yearsNumber of Patients Who Experience \>= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) from baseline to any post-baseline time point.
Outcome measures
| Measure |
AC/PTL
n=104 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF)
Drop ≤ 10 between any 2 time points
|
41 Participants
|
|
Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF)
Drop ≥ 10 between any 2 time points
|
63 Participants
|
SECONDARY outcome
Timeframe: 5 yearsDFS was defined as the time from registration to the earliest date of documentation of any local, regional, or distant recurrence of breast cancer (BC); the development of a contralateral BC or second primary other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death from any cause without the documentation of one of these events. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
AC/PTL
n=109 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Percentage of Participants With Disease-Free Survival (DFS)
|
91.9 percentage of participants
Interval 84.5 to 95.9
|
SECONDARY outcome
Timeframe: 5 yearsOS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
AC/PTL
n=109 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Percentage of Participants With Overall Survival (OS)
|
95.0 percentage of participants
Interval 88.4 to 97.9
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Number who completed the QOL questions for each Timeframe.
LASA score is from 0-90 with 0 being the worst and 90 being the best. SDS score is from 13-65 with 65 being the worst and 13 being the best.
Outcome measures
| Measure |
AC/PTL
n=109 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
LASA Time from Cycle 5 Baseline (Months 2-3)
|
-11.1 units on a scale
Interval -14.9 to -7.3
|
|
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
LASA Time from Cycle 5 Baseline (Months 5-6)
|
-13.2 units on a scale
Interval -18.2 to -8.1
|
|
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
LASA Time from Cycle 5 Baseline (Month 18-Year 3)
|
-3.6 units on a scale
Interval -8.2 to 1.0
|
|
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
LASA Time from Cycle 5 Baseline (Year 4-5)
|
-0.5 units on a scale
Interval -5.0 to 4.0
|
|
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
SDS Time from Cycle 5 Baseline (Months 2-3)
|
-6.7 units on a scale
Interval -9.2 to -4.3
|
|
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
SDS Time from Cycle 5 Baseline (Months 5-6)
|
-9.5 units on a scale
Interval -12.1 to -6.9
|
|
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
SDS Time from Cycle 5 Baseline (Month 18-Year 3)
|
-1.4 units on a scale
Interval -4.1 to 1.4
|
|
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
SDS Time from Cycle 5 Baseline (Year 4-5)
|
0.3 units on a scale
Interval -2.5 to 3.1
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Number who completed the QOL questions for each Timeframe.
Overall Symptom Distress Scale (SDS) QOL Measurement and Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) QOL Measurement
Outcome measures
| Measure |
AC/PTL
n=109 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
SDS Time from Cycle 5 Baseline (Months 2-3)
|
32 Participants
|
|
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
SDS Time from Cycle 5 Baseline (Months 5-6)
|
33 Participants
|
|
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
SDS Time from Cycle 5 Baseline (Month 18-Year 3)
|
12 Participants
|
|
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
SDS Time from Cycle 5 Baseline (Year 4-5)
|
7 Participants
|
|
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
LASA Time from Cycle 5 Baseline (Months 2-3)
|
67 Participants
|
|
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
LASA Time from Cycle 5 Baseline (Months 5-6)
|
45 Participants
|
|
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
LASA Time from Cycle 5 Baseline (Month 18-3 Year)
|
40 Participants
|
|
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
LASA Time from Cycle 5 Baseline (Year 4-5)
|
19 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: No patients experienced grade 3 or higher pulmonary adverse events at least possibly related to study treatment after at any time after post-AC treatment began.
Pulmonary events to be included were grade 3 and higher pulmonary adverse events at least possibly related to study treatment, which occur at any time after post-AC treatment is begun, but prior to documentation of a breast cancer recurrence, contralateral breast cancer, secondary primary cancer, non-pulmonary death, or pulmonary death not related to study treatment.
Outcome measures
| Measure |
AC/PTL
n=109 Participants
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Incidence of Pulmonary Events
|
0 pulmonary adverse events
|
Adverse Events
AC/PTL
Serious events: 17 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AC/PTL
n=108 participants at risk
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Cardiac disorders
Left ventricular failure
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
6/108 • Number of events 9
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
General disorders
Fatigue
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Pneumonia
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Skin infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Urinary tract infection
|
0.93%
1/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Alanine aminotransferase increased
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Aspartate aminotransferase increased
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Leukopenia
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Neutrophil count decreased
|
3.7%
4/108 • Number of events 4
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Vascular disorders
Thrombosis
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
Other adverse events
| Measure |
AC/PTL
n=108 participants at risk
Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
30.6%
33/108 • Number of events 80
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
4/108 • Number of events 4
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Cardiac disorders
Diastolic dysfunction
|
8.3%
9/108 • Number of events 17
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Cardiac disorders
Left ventricular failure
|
41.7%
45/108 • Number of events 87
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Ear and labyrinth disorders
Ear pain
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Eye disorders
Dry eye
|
1.9%
2/108 • Number of events 4
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Eye disorders
Vision
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Eye disorders
Vision-Blurred
|
2.8%
3/108 • Number of events 4
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Eye disorders
Watering eyes
|
0.93%
1/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
4/108 • Number of events 4
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.93%
1/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Constipation
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Diarrhea
|
86.1%
93/108 • Number of events 426
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Dry mouth
|
1.9%
2/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
9/108 • Number of events 16
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Esophagitis
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Flatulence
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Gastritis
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.2%
11/108 • Number of events 17
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Nausea
|
28.7%
31/108 • Number of events 60
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Oral cavity Mucositis/stomatitis (clinical exam)
|
7.4%
8/108 • Number of events 12
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Oral pain
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Rectal pain
|
0.93%
1/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
16/108 • Number of events 23
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
General disorders
Chills
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
General disorders
Constitutional Symptoms
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
General disorders
Edema limbs
|
4.6%
5/108 • Number of events 6
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
General disorders
Fatigue
|
93.5%
101/108 • Number of events 624
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
General disorders
Fever
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
General disorders
Influenza Symptoms
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
General disorders
Pain-Chest
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Immune system disorders
Hypersensitivity
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Bladder infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Bronchial infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Catheter related infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Clostridial infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Dental-tooth infection
|
0.93%
1/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Infection without neutropenia
|
2.8%
3/108 • Number of events 5
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Mucosa infection
|
0.93%
1/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Opportunisitic infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Pneumonia
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Sinus infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Sinusitis
|
2.8%
3/108 • Number of events 4
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Skin (cellulites) infection
|
2.8%
3/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Stomach infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Upper airway infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Urinary tract infection
|
2.8%
3/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Vaginal infection
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Infections and infestations
Wound infection
|
1.9%
2/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Injury, poisoning and procedural complications
Appendix injury
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Alanine aminotransferase increased
|
18.5%
20/108 • Number of events 60
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Alkaline phosphatase increased
|
0.93%
1/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Aspartate aminotransferase increased
|
18.5%
20/108 • Number of events 49
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Leukopenia
|
29.6%
32/108 • Number of events 96
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Lymphopenia
|
11.1%
12/108 • Number of events 31
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Neutrophil count decreased
|
32.4%
35/108 • Number of events 85
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Platelet count decreased
|
5.6%
6/108 • Number of events 6
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Investigations
Weight loss
|
3.7%
4/108 • Number of events 15
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.5%
7/108 • Number of events 17
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
9/108 • Number of events 14
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.8%
3/108 • Number of events 5
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.93%
1/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.93%
1/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.6%
5/108 • Number of events 6
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.9%
2/108 • Number of events 5
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Metabolism and nutrition disorders
Obesity
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.9%
55/108 • Number of events 216
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
49.1%
53/108 • Number of events 136
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.7%
58/108 • Number of events 199
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Dizziness
|
6.5%
7/108 • Number of events 8
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Headache
|
6.5%
7/108 • Number of events 12
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Neuralgia
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
59.3%
64/108 • Number of events 348
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Sinus pain
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Syncope
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Nervous system disorders
Taste
|
5.6%
6/108 • Number of events 16
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Psychiatric disorders
Agitation
|
1.9%
2/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Psychiatric disorders
Anxiety
|
4.6%
5/108 • Number of events 5
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Psychiatric disorders
Confusion
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Psychiatric disorders
Depression
|
2.8%
3/108 • Number of events 6
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Psychiatric disorders
Insomnia
|
5.6%
6/108 • Number of events 9
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Renal and urinary disorders
Bladder spasm
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Renal and urinary disorders
Cystitis
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Renal and urinary disorders
Glomerular filtration rate
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Renal and urinary disorders
Urethra Hemorrhage
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
1.9%
2/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.6%
46/108 • Number of events 133
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
3/108 • Number of events 3
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
3/108 • Number of events 11
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Acne
|
49.1%
53/108 • Number of events 177
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.5%
34/108 • Number of events 144
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Dermatology
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.6%
5/108 • Number of events 6
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
5.6%
6/108 • Number of events 11
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
10.2%
11/108 • Number of events 21
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
2/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.9%
2/108 • Number of events 4
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.93%
1/108 • Number of events 2
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Vascular disorders
Flushing
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Vascular disorders
Hot flashes
|
4.6%
5/108 • Number of events 8
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
|
Vascular disorders
Hypotension
|
0.93%
1/108 • Number of events 1
Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place