Trial Outcomes & Findings for Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer (NCT NCT01750073)
NCT ID: NCT01750073
Last Updated: 2025-11-18
Results Overview
The number of participants in the subgroups who had a pathologic complete response (pCR) determined from the surgical specimen and defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Up to 12 weeks (after the first 6 courses of treatment), maximum of 168 days
Results posted on
2025-11-18
Participant Flow
99 subjects were enrolled but 7 were screen fails (after signing consent) so only 92 started.
Participant milestones
| Measure |
Treatment (chemotherapy, surgery, post-operative therapy)
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
HER2-positive
|
19
|
|
Overall Study
HER2-negative
|
73
|
|
Overall Study
COMPLETED
|
87
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Surgery, Post-operative Therapy)
n=92 Participants
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
|---|---|
|
Age, Continuous
|
57.65 Years
STANDARD_DEVIATION 10.19 • n=202 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=202 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=202 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
|
Stage of Cancer
Stage I
|
22 Participants
n=202 Participants
|
|
Stage of Cancer
Stage II
|
65 Participants
n=202 Participants
|
|
Stage of Cancer
Stage IIIA
|
5 Participants
n=202 Participants
|
|
Her-2 NEU Status (human epidermal growth factor receptor)
Negative
|
73 Participants
n=202 Participants
|
|
Her-2 NEU Status (human epidermal growth factor receptor)
Positive
|
19 Participants
n=202 Participants
|
|
ER Status
Negative
|
35 Participants
n=202 Participants
|
|
ER Status
Positive
|
57 Participants
n=202 Participants
|
|
PR Status (progesterone receptors)
Negative
|
49 Participants
n=202 Participants
|
|
PR Status (progesterone receptors)
Positive
|
43 Participants
n=202 Participants
|
|
Triple Negative
No
|
63 Participants
n=202 Participants
|
|
Triple Negative
Yes
|
29 Participants
n=202 Participants
|
|
Treatment
paclitaxel & cyclophosphamide (PC) + Adriamycin
|
17 Participants
n=202 Participants
|
|
Treatment
paclitaxel & cyclophosphamide (PC)
|
56 Participants
n=202 Participants
|
|
Treatment
paclitaxel, cyclophosphamide & trastuzumab (PCH)
|
19 Participants
n=202 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after completion of study treatment, maximum of 114 daysPopulation: All subjects who received at least one cycle of treatment and experienced an adverse event.
Number of participants in each subset (Her2 positive and Her2 negative) who experience at least one adverse event \[overall incidence of toxicities, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\].
Outcome measures
| Measure |
Her-2 Negative
n=73 Participants
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
Her-2 Positive
n=19 Participants
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
|---|---|---|
|
Overall Incidence of Toxicities, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
73 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after completion of study treatment, maximum of 114 daysPopulation: Participant events were analyzed for each group-Her-2 Negative and Her-2 Positive
Results reported as total events per grade for human epidermal growth factor receptor 2 (HER2)negative and HER2 positive (Overall severity of toxicities, graded according to the NCI CTCAE version 4.0).
Outcome measures
| Measure |
Her-2 Negative
n=1816 Events
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
Her-2 Positive
n=496 Events
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
|---|---|---|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
Non-SAE grade 4
|
11 Events
|
4 Events
|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
SAE grade 5
|
1 Events
|
1 Events
|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
Non-SAE grade 1
|
1286 Events
|
302 Events
|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
Non-SAE grade 2
|
390 Events
|
143 Events
|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
Non-SAE grade 3
|
93 Events
|
23 Events
|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
SAE grade 3
|
22 Events
|
8 Events
|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
SAE grade 4
|
2 Events
|
2 Events
|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
SAE grade 2
|
10 Events
|
4 Events
|
|
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
SAE grade 1
|
1 Events
|
9 Events
|
PRIMARY outcome
Timeframe: Up to 12 weeks (after the first 6 courses of treatment), maximum of 168 daysPopulation: Participants who completed 6 courses of treatment (87). 16 subjects were not evaluated. Total of 71 participants were evaluated.
The number of participants in the subgroups who had a pathologic complete response (pCR) determined from the surgical specimen and defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ.
Outcome measures
| Measure |
Her-2 Negative
n=56 Participants
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
Her-2 Positive
n=15 Participants
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
|---|---|---|
|
Number of Participants in the Subgroups Who Had a Pathologic Complete Response (pCR)
|
13 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe absence of all detectable cancer after treatment is complete.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time from the date of administration of study drug to the date of first appearance of tumor lesions by imaging, or death, assessed up to 2 yearsThe analysis will be based on Kaplan-Meier estimates. FFS will be summarized overall and for human epidermal growth factor receptor 2 (HER2)+ and HER- subsets.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsThe number of the identified mutated genes, the frequency of each gene being validated by reverse transcriptase-polymerase chain reaction (RT-PCR)/Sanger sequencing method, and the functions of these identified genes will be descriptively summarized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time from the date of the date of administration of study drug to the date of death from any cause, assessed up to 2 yearsThe analysis will be based on Kaplan-Meier estimates. OAS will be summarized overall and for HER+ and HER- subsets.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (chemotherapy, surgery, post-operative therapy)
Serious events: 16 serious events
Other events: 92 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (chemotherapy, surgery, post-operative therapy)
n=92 participants at risk
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.4%
5/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
3/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Infections and infestations
Infections and Infestations
|
3.3%
3/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Infections and infestations
Sepsis
|
3.3%
3/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
2/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
General disorders
Fever
|
2.2%
2/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
2/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Neutrophil count decreased
|
2.2%
2/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
General disorders
non-cardiac chest pain
|
2.2%
2/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
2/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Infections and infestations
Urinary tract infection
|
2.2%
2/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
white blood cell decreased
|
2.2%
2/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Cardiac disorders
Asystole
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Blood bilirubin increased
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Cardiac troponin I increased
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Creatinine increased
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Vascular disorders
Hypotension
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
General disorders
Infusion related reaction
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Oral pain
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
General disorders
Pain
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Cardiac disorders
Pericarditis
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Platelet count decreased
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Nervous system disorders
Presyncope
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Nervous system disorders
Seizure
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/92 • 30 days after last administration of study medication, maximum of 114 days
|
Other adverse events
| Measure |
Treatment (chemotherapy, surgery, post-operative therapy)
n=92 participants at risk
See Detailed Description
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Radiation Therapy: Undergo RT
Therapeutic Conventional Surgery: Undergo mastectomy or breast conserving surgery
Trastuzumab: Given IV
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
26.1%
24/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.7%
20/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Psychiatric disorders
Anxiety
|
19.6%
18/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Neutrophil count decreased
|
18.5%
17/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
General disorders
Pain
|
18.5%
17/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.4%
16/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Aspartate aminotransferase increased
|
17.4%
16/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.4%
16/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.3%
15/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Mucositis oral
|
16.3%
15/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.3%
15/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Vascular disorders
Hypertension
|
15.2%
14/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Lymphocyte count decreased
|
15.2%
14/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.2%
14/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Nervous system disorders
Dysgeusia
|
14.1%
13/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Dyspepsia
|
14.1%
13/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
General disorders
Fever
|
14.1%
13/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.1%
13/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Platelet count decreased
|
14.1%
13/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Creatinine increased
|
12.0%
11/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Psychiatric disorders
Depression
|
12.0%
11/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
General disorders
Edema limbs
|
12.0%
11/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Vascular disorders
Hot flashes
|
12.0%
11/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.9%
10/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Nervous system disorders
Dizziness
|
10.9%
10/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Vascular disorders
Flushing
|
10.9%
10/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.9%
10/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
10.9%
10/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
9/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Eye disorders
Blurred vision
|
8.7%
8/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
8/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.7%
8/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
8.7%
8/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Anorexia
|
7.6%
7/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.6%
7/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
6/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.5%
6/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Infections and infestations
Upper respiratory infection
|
6.5%
6/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Renal and urinary disorders
Urinary incontinence
|
6.5%
6/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Immune system disorders
Allergic reaction
|
5.4%
5/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Cardiac disorders
Palpitations
|
5.4%
5/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.4%
5/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Renal and urinary disorders
Urinary frequency
|
5.4%
5/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Infections and infestations
Urinary tract infection
|
5.4%
5/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
71.7%
66/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
General disorders
Fatigue
|
59.8%
55/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
Alkaline phosphatase increased
|
58.7%
54/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Blood and lymphatic system disorders
Anemia
|
53.3%
49/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Nausea
|
52.2%
48/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
44.6%
41/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Investigations
White blood cell decreased
|
41.3%
38/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
39.1%
36/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Constipation
|
38.0%
35/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
38.0%
35/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Nervous system disorders
Headache
|
32.6%
30/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
32.6%
30/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Gastrointestinal disorders
Diarrhea
|
31.5%
29/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Psychiatric disorders
Insomnia
|
31.5%
29/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
30.4%
28/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.3%
26/92 • 30 days after last administration of study medication, maximum of 114 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
88.0%
81/92 • 30 days after last administration of study medication, maximum of 114 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place