Trial Outcomes & Findings for Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048) (NCT NCT00550771)
NCT ID: NCT00550771
Last Updated: 2017-06-07
Results Overview
Cardiac events defined as: Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of \>10 percentage points from baseline and to ≤50% LVEF Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of \>10 percentage points from baseline and to \<50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Pegylated Liposomal Doxorubicin (PLD) Based Regimen
PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
|
Doxorubicin Based Regimen
doxorubicin 60 mg/m\^2 intravenous (IV) push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
60
|
|
Overall Study
COMPLETED
|
104
|
50
|
|
Overall Study
NOT COMPLETED
|
17
|
10
|
Reasons for withdrawal
| Measure |
Pegylated Liposomal Doxorubicin (PLD) Based Regimen
PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
|
Doxorubicin Based Regimen
doxorubicin 60 mg/m\^2 intravenous (IV) push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
3
|
|
Overall Study
Discontinued for study-related reasons
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
4
|
5
|
Baseline Characteristics
Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048)
Baseline characteristics by cohort
| Measure |
Pegylated Liposomal Doxorubicin (PLD) Based Regimen
n=120 Participants
PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
|
Doxorubicin Based Regimen
n=59 Participants
doxorubicin 60 mg/m\^2 intravenous (IV) push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 9.32 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
179 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: 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatmentPopulation: ITT, defined as all participants who were randomized and received at least 1 dose of any study medication. Each participant could not contribute more than 1 event.
Cardiac events defined as: Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of \>10 percentage points from baseline and to ≤50% LVEF Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of \>10 percentage points from baseline and to \<50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) Based Regimen
n=120 Participants
PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
|
Doxorubicin Based Regimen
n=59 Participants
doxorubicin 60 mg/m\^2 intravenous (IV) push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
|
|---|---|---|
|
Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: During the 8 courses of chemotherapyPopulation: ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.
Cardiac events defined as: Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of \>10 percentage points from baseline and to ≤50% LVEF Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of \>10 percentage points from baseline and to \<50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) Based Regimen
n=120 Participants
PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
|
Doxorubicin Based Regimen
n=59 Participants
doxorubicin 60 mg/m\^2 intravenous (IV) push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
|
|---|---|---|
|
Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy
Level 1 Cardiotoxicity
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy
Level 2 Cardiotoxicity
|
1 Participants
|
3 Participants
|
|
Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy
Inability to Administer Trastuzumab
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During 1 year of trastuzumab therapyPopulation: ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.
Cardiac events defined as: Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of \>10 percentage points from baseline and to ≤50% LVEF Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of \>10 percentage points from baseline and to \<50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) Based Regimen
n=116 Participants
PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
|
Doxorubicin Based Regimen
n=52 Participants
doxorubicin 60 mg/m\^2 intravenous (IV) push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
|
|---|---|---|
|
Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy
Level 2 Cardiotoxicity
|
4 Participants
|
10 Participants
|
|
Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy
Inability to Administer Trastuzumab
|
4 Participants
|
8 Participants
|
|
Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy
Level 1 Cardiotoxicity
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 2 yearsRelapse-free survival would have been determined by Kaplan-Meier method. This was not calculated, since the 2 year follow-up was curtailed.
Outcome measures
Outcome data not reported
Adverse Events
PLD Based Regimen
Serious events: 20 serious events
Other events: 115 other events
Deaths: 0 deaths
Doxorubicin Based Regimen
Serious events: 7 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLD Based Regimen
n=120 participants at risk
|
Doxorubicin Based Regimen
n=59 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.83%
1/120 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
4.2%
5/120 • Number of events 6
|
6.8%
4/59 • Number of events 5
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/120
|
3.4%
2/59 • Number of events 2
|
|
Cardiac disorders
ATRIAL THROMBOSIS
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.83%
1/120 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Cardiac disorders
PLEUROPERICARDITIS
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Gastrointestinal disorders
GASTRIC ULCER PERFORATION
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Gastrointestinal disorders
NAUSEA
|
0.83%
1/120 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/120
|
3.4%
2/59 • Number of events 2
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
General disorders
MALAISE
|
0.00%
0/120
|
3.4%
2/59 • Number of events 2
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
General disorders
PAIN
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
General disorders
PYREXIA
|
5.8%
7/120 • Number of events 9
|
3.4%
2/59 • Number of events 2
|
|
Infections and infestations
CELLULITIS
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.83%
1/120 • Number of events 1
|
1.7%
1/59 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.83%
1/120 • Number of events 1
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
1.7%
2/120 • Number of events 2
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/120
|
1.7%
1/59 • Number of events 1
|
Other adverse events
| Measure |
PLD Based Regimen
n=120 participants at risk
|
Doxorubicin Based Regimen
n=59 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.0%
6/120 • Number of events 10
|
10.2%
6/59 • Number of events 8
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
6.7%
8/120 • Number of events 18
|
6.8%
4/59 • Number of events 16
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
1.7%
2/120 • Number of events 12
|
5.1%
3/59 • Number of events 3
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
22.5%
27/120 • Number of events 72
|
44.1%
26/59 • Number of events 37
|
|
Cardiac disorders
PALPITATIONS
|
10.0%
12/120 • Number of events 17
|
6.8%
4/59 • Number of events 7
|
|
Eye disorders
DRY EYE
|
2.5%
3/120 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
|
Eye disorders
LACRIMATION INCREASED
|
9.2%
11/120 • Number of events 12
|
10.2%
6/59 • Number of events 6
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.7%
8/120 • Number of events 13
|
11.9%
7/59 • Number of events 10
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.7%
8/120 • Number of events 8
|
11.9%
7/59 • Number of events 10
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.8%
31/120 • Number of events 45
|
33.9%
20/59 • Number of events 38
|
|
Gastrointestinal disorders
DIARRHOEA
|
28.3%
34/120 • Number of events 65
|
28.8%
17/59 • Number of events 33
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.83%
1/120 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
|
Gastrointestinal disorders
DYSPEPSIA
|
20.0%
24/120 • Number of events 35
|
6.8%
4/59 • Number of events 5
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
5.0%
6/120 • Number of events 7
|
6.8%
4/59 • Number of events 5
|
|
Gastrointestinal disorders
NAUSEA
|
52.5%
63/120 • Number of events 100
|
59.3%
35/59 • Number of events 70
|
|
Gastrointestinal disorders
STOMATITIS
|
23.3%
28/120 • Number of events 41
|
22.0%
13/59 • Number of events 18
|
|
Gastrointestinal disorders
VOMITING
|
22.5%
27/120 • Number of events 37
|
22.0%
13/59 • Number of events 22
|
|
General disorders
ASTHENIA
|
25.0%
30/120 • Number of events 72
|
18.6%
11/59 • Number of events 27
|
|
General disorders
CHEST PAIN
|
5.8%
7/120 • Number of events 8
|
3.4%
2/59 • Number of events 5
|
|
General disorders
FATIGUE
|
42.5%
51/120 • Number of events 102
|
61.0%
36/59 • Number of events 71
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
2.5%
3/120 • Number of events 5
|
6.8%
4/59 • Number of events 4
|
|
General disorders
MALAISE
|
0.00%
0/120
|
6.8%
4/59 • Number of events 9
|
|
General disorders
MUCOSAL INFLAMMATION
|
34.2%
41/120 • Number of events 82
|
27.1%
16/59 • Number of events 21
|
|
General disorders
OEDEMA
|
5.0%
6/120 • Number of events 7
|
8.5%
5/59 • Number of events 7
|
|
General disorders
OEDEMA PERIPHERAL
|
19.2%
23/120 • Number of events 31
|
18.6%
11/59 • Number of events 13
|
|
General disorders
PAIN
|
2.5%
3/120 • Number of events 5
|
5.1%
3/59 • Number of events 3
|
|
General disorders
PYREXIA
|
15.8%
19/120 • Number of events 28
|
16.9%
10/59 • Number of events 14
|
|
Immune system disorders
HYPERSENSITIVITY
|
7.5%
9/120 • Number of events 16
|
5.1%
3/59 • Number of events 3
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.5%
9/120 • Number of events 9
|
10.2%
6/59 • Number of events 6
|
|
Infections and infestations
SINUSITIS
|
0.83%
1/120 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
|
Investigations
WEIGHT INCREASED
|
19.2%
23/120 • Number of events 26
|
23.7%
14/59 • Number of events 23
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
24.2%
29/120 • Number of events 38
|
23.7%
14/59 • Number of events 26
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.0%
6/120 • Number of events 8
|
11.9%
7/59 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.2%
11/120 • Number of events 13
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
4.2%
5/120 • Number of events 9
|
5.1%
3/59 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.8%
7/120 • Number of events 7
|
6.8%
4/59 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
16.7%
20/120 • Number of events 26
|
23.7%
14/59 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.2%
5/120 • Number of events 5
|
8.5%
5/59 • Number of events 5
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.83%
1/120 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
|
Nervous system disorders
DIZZINESS
|
9.2%
11/120 • Number of events 16
|
18.6%
11/59 • Number of events 14
|
|
Nervous system disorders
DYSGEUSIA
|
13.3%
16/120 • Number of events 27
|
13.6%
8/59 • Number of events 15
|
|
Nervous system disorders
HEADACHE
|
15.0%
18/120 • Number of events 30
|
18.6%
11/59 • Number of events 20
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
9.2%
11/120 • Number of events 13
|
13.6%
8/59 • Number of events 12
|
|
Nervous system disorders
NEUROTOXICITY
|
5.8%
7/120 • Number of events 12
|
6.8%
4/59 • Number of events 5
|
|
Nervous system disorders
PARAESTHESIA
|
8.3%
10/120 • Number of events 12
|
8.5%
5/59 • Number of events 6
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
1.7%
2/120 • Number of events 2
|
8.5%
5/59 • Number of events 8
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
13.3%
16/120 • Number of events 35
|
15.3%
9/59 • Number of events 18
|
|
Psychiatric disorders
ANXIETY
|
8.3%
10/120 • Number of events 11
|
3.4%
2/59 • Number of events 2
|
|
Psychiatric disorders
DEPRESSION
|
3.3%
4/120 • Number of events 5
|
6.8%
4/59 • Number of events 4
|
|
Psychiatric disorders
INSOMNIA
|
12.5%
15/120 • Number of events 18
|
11.9%
7/59 • Number of events 9
|
|
Renal and urinary disorders
DYSURIA
|
3.3%
4/120 • Number of events 4
|
6.8%
4/59 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.8%
19/120 • Number of events 24
|
27.1%
16/59 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
22.5%
27/120 • Number of events 34
|
20.3%
12/59 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
21.7%
26/120 • Number of events 36
|
20.3%
12/59 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
8.3%
10/120 • Number of events 13
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
6.7%
8/120 • Number of events 10
|
8.5%
5/59 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
49.2%
59/120 • Number of events 75
|
76.3%
45/59 • Number of events 55
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
3.3%
4/120 • Number of events 4
|
8.5%
5/59 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
15.0%
18/120 • Number of events 29
|
3.4%
2/59 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
4.2%
5/120 • Number of events 6
|
10.2%
6/59 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
65.8%
79/120 • Number of events 183
|
5.1%
3/59 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
RASH
|
29.2%
35/120 • Number of events 68
|
10.2%
6/59 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
5.8%
7/120 • Number of events 8
|
0.00%
0/59
|
|
Vascular disorders
FLUSHING
|
5.8%
7/120 • Number of events 8
|
3.4%
2/59 • Number of events 2
|
|
Vascular disorders
HOT FLUSH
|
8.3%
10/120 • Number of events 13
|
8.5%
5/59 • Number of events 6
|
|
Vascular disorders
HYPERTENSION
|
3.3%
4/120 • Number of events 5
|
5.1%
3/59 • Number of events 4
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigators (PIs) agree not to publish/publicly present any interim study results without prior sponsor written consent. The PIs further agree to provide 45 days written notice to the sponsor, prior to submission for publication or presentation, to permit the sponsor to review abstracts/manuscripts, which report any study results. The sponsor has the right to review/comment. If the parties disagree, the PIs agree to meet with the sponsor, prior to submission, to discuss/resolve.
- Publication restrictions are in place
Restriction type: OTHER