Trial Outcomes & Findings for Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens (NCT NCT00149214)
NCT ID: NCT00149214
Last Updated: 2012-03-21
Results Overview
pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
257 participants
Primary outcome timeframe
surgery after eight 21-day cycles of chemotherapy
Results posted on
2012-03-21
Participant Flow
The one participant who was randomized to pemetrexed but treated with cyclophosphamide is included in the as randomized group (pemetrexed) for the purposes of the participant flow, excluded from the efficacy analyses (per the protocol), but in the as treated group (cyclophosphamide) for safety analyses.
Participant milestones
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
122
|
|
Overall Study
COMPLETED
|
109
|
105
|
|
Overall Study
NOT COMPLETED
|
26
|
17
|
Reasons for withdrawal
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
|
Overall Study
Progressive Disease
|
7
|
3
|
Baseline Characteristics
Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
Baseline characteristics by cohort
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
n=135 Participants
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
n=122 Participants
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
49.9 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
49.5 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
49.7 years
STANDARD_DEVIATION 10.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=93 Participants
|
122 Participants
n=4 Participants
|
257 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
36 participants
n=93 Participants
|
29 participants
n=4 Participants
|
65 participants
n=27 Participants
|
|
Region of Enrollment
Russian Federation
|
14 participants
n=93 Participants
|
14 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
74 participants
n=93 Participants
|
71 participants
n=4 Participants
|
145 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=93 Participants
|
8 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Grade 0 - Fully active
|
131 participants
n=93 Participants
|
113 participants
n=4 Participants
|
244 participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Grade 1- Ambulatory; strenuous activity restricted
|
1 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Status Unknown
|
3 participants
n=93 Participants
|
5 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Estrogen and Progesterone Receptor Status
At least one positive
|
90 participants
n=93 Participants
|
78 participants
n=4 Participants
|
168 participants
n=27 Participants
|
|
Estrogen and Progesterone Receptor Status
Both negative
|
45 participants
n=93 Participants
|
44 participants
n=4 Participants
|
89 participants
n=27 Participants
|
|
Menopausal Status
Unknown
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Menopausal Status
Pre-Menopausal
|
69 participants
n=93 Participants
|
66 participants
n=4 Participants
|
135 participants
n=27 Participants
|
|
Menopausal Status
Peri-Menopausal
|
6 participants
n=93 Participants
|
7 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Menopausal Status
Post-Menopausal
|
60 participants
n=93 Participants
|
48 participants
n=4 Participants
|
108 participants
n=27 Participants
|
|
Race/Ethnicity
Caucasian
|
135 participants
n=93 Participants
|
119 participants
n=4 Participants
|
254 participants
n=27 Participants
|
|
Race/Ethnicity
Hispanic
|
0 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: surgery after eight 21-day cycles of chemotherapyPopulation: Participants meeting the following criteria qualify for pathological tumor response: * Histologic diagnosis of primary operable breast cancer * No concurrent antitumor therapy * Specimen for evaluation of pathological response obtained upon surgery * Treatment with at least one dose of study drug of the assigned study regimen.
pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
Outcome measures
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
n=127 Participants
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
n=119 Participants
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Number of Participants With a Pathological Complete Response
Pathological Complete Response
|
21 participants
|
24 participants
|
|
Number of Participants With a Pathological Complete Response
Tumor Cells Still Present
|
99 participants
|
89 participants
|
|
Number of Participants With a Pathological Complete Response
Not evaluable
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Cycles 1-4 (21-day cycles)Population: Participants meeting following criteria qualify for clinical tumor response: * Histologic diagnosis of primary operable breast cancer * No concurrent antitumor therapy up to surgery * Presence of measurable disease as defined by RECIST. * Treatment with at least one dose of study drug of assigned study regimen.
The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.
Outcome measures
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
n=131 Participants
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
n=119 Participants
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
Complete Response
|
8 participants
|
9 participants
|
|
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
Partial Response
|
45 participants
|
43 participants
|
|
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
Stable Disease
|
49 participants
|
44 participants
|
|
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
Progressive Disease
|
3 participants
|
2 participants
|
|
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
Unknown
|
17 participants
|
17 participants
|
|
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
Not Done
|
9 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Cycles 5-8 (21-day cycles)Population: Participants meeting following criteria qualify for clinical tumor response: * Histologic diagnosis of primary operable breast cancer * No concurrent antitumor therapy up to surgery * Presence of measurable disease as defined by RECIST. * Treatment with at least one dose of study drug of assigned study regimen.
The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.
Outcome measures
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
n=131 Participants
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
n=119 Participants
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
Complete Tumor Response
|
19 participants
|
21 participants
|
|
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
Partial Tumor Response
|
59 participants
|
60 participants
|
|
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
Stable Disease
|
35 participants
|
24 participants
|
|
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
Progressive Disease
|
2 participants
|
1 participants
|
|
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
Unknown
|
9 participants
|
10 participants
|
|
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
Not Done
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: surgery after eight 21-day cycles of chemotherapyPopulation: Participants meeting the following criteria qualify for pathological tumor response: * Histologic diagnosis of primary operable breast cancer * No concurrent antitumor therapy * Specimen for evaluation of pathological response obtained upon surgery * Treatment with at least one dose of study drug of the assigned study regimen.
Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.
Outcome measures
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
n=127 Participants
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
n=119 Participants
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery
|
64 participants
|
63 participants
|
SECONDARY outcome
Timeframe: baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)Population: All randomized participants. In the Pemetrexed plus Doxorubicin, Followed by Docetaxel arm, 99 participants were censored. In the Cyclophosphamide plus Doxorubicin, Followed by Docetaxel arm, 94 participants were censored.
Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.
Outcome measures
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
n=135 Participants
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
n=122 Participants
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Disease-free Survival
|
NA months
Interval 47.96 to
The median and upper limit of the 95% confidence interval were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
NA months
Interval 54.38 to
The median and upper limit of the 95% confidence interval were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
Adverse Events
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
Serious events: 15 serious events
Other events: 134 other events
Deaths: 0 deaths
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Serious events: 25 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
n=134 participants at risk
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
n=123 participants at risk
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Blood and lymphatic system disorders
Chronic lymphocytic leukaemia
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
4/134 • Number of events 5
|
4.1%
5/123 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.0%
4/134 • Number of events 4
|
7.3%
9/123 • Number of events 9
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.75%
1/134 • Number of events 1
|
2.4%
3/123 • Number of events 3
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.75%
1/134 • Number of events 2
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.5%
2/134 • Number of events 2
|
0.00%
0/123
|
|
Gastrointestinal disorders
Stomatitis
|
0.75%
1/134 • Number of events 1
|
0.00%
0/123
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
3/134 • Number of events 4
|
0.00%
0/123
|
|
General disorders
Fatigue
|
0.00%
0/134
|
1.6%
2/123 • Number of events 2
|
|
General disorders
General physical health deterioration
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
General disorders
Inflammation
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
General disorders
Injection site extravasation
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/134
|
1.6%
2/123 • Number of events 2
|
|
General disorders
Pyrexia
|
2.2%
3/134 • Number of events 3
|
4.1%
5/123 • Number of events 5
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/134
|
1.6%
2/123 • Number of events 2
|
|
Infections and infestations
Febrile infection
|
0.75%
1/134 • Number of events 1
|
0.00%
0/123
|
|
Infections and infestations
Infection
|
0.75%
1/134 • Number of events 1
|
0.00%
0/123
|
|
Infections and infestations
Pharyngitis
|
0.75%
1/134 • Number of events 1
|
0.00%
0/123
|
|
Infections and infestations
Pneumonia
|
0.75%
1/134 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Vulvitis
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.75%
1/134 • Number of events 1
|
0.00%
0/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Psychiatric disorders
Major depression
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Renal and urinary disorders
Nephritis
|
0.75%
1/134 • Number of events 1
|
0.00%
0/123
|
|
Vascular disorders
Axillary vein thrombosis
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Vascular disorders
Hypovolaemic shock
|
0.75%
1/134 • Number of events 1
|
0.00%
0/123
|
|
Vascular disorders
Peripheral vascular disorder
|
0.75%
1/134 • Number of events 1
|
0.00%
0/123
|
|
Vascular disorders
Post procedural haematoma
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/134
|
0.81%
1/123 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed Plus Doxorubicin, Followed by Docetaxel
n=134 participants at risk
pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
n=123 participants at risk
cyclophosphamide: 600 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.5%
10/134 • Number of events 17
|
8.9%
11/123 • Number of events 19
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.7%
13/134 • Number of events 29
|
7.3%
9/123 • Number of events 18
|
|
Blood and lymphatic system disorders
Leukopenia
|
49.3%
66/134 • Number of events 229
|
54.5%
67/123 • Number of events 252
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.2%
19/134 • Number of events 53
|
14.6%
18/123 • Number of events 50
|
|
Blood and lymphatic system disorders
Neutropenia
|
48.5%
65/134 • Number of events 223
|
59.3%
73/123 • Number of events 244
|
|
Blood and lymphatic system disorders
Neutrophilia
|
5.2%
7/134 • Number of events 14
|
3.3%
4/123 • Number of events 7
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
6.7%
9/134 • Number of events 12
|
4.1%
5/123 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.0%
8/134 • Number of events 18
|
9.8%
12/123 • Number of events 22
|
|
Eye disorders
Conjunctivitis
|
14.2%
19/134 • Number of events 32
|
8.1%
10/123 • Number of events 14
|
|
Eye disorders
Lacrimation increased
|
11.9%
16/134 • Number of events 20
|
11.4%
14/123 • Number of events 15
|
|
Gastrointestinal disorders
Abdominal pain
|
11.9%
16/134 • Number of events 18
|
9.8%
12/123 • Number of events 17
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.7%
21/134 • Number of events 24
|
8.9%
11/123 • Number of events 12
|
|
Gastrointestinal disorders
Constipation
|
36.6%
49/134 • Number of events 81
|
28.5%
35/123 • Number of events 51
|
|
Gastrointestinal disorders
Diarrhoea
|
24.6%
33/134 • Number of events 50
|
22.0%
27/123 • Number of events 42
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
10/134 • Number of events 11
|
7.3%
9/123 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
61.2%
82/134 • Number of events 207
|
65.9%
81/123 • Number of events 210
|
|
Gastrointestinal disorders
Stomatitis
|
39.6%
53/134 • Number of events 95
|
38.2%
47/123 • Number of events 90
|
|
Gastrointestinal disorders
Vomiting
|
22.4%
30/134 • Number of events 43
|
32.5%
40/123 • Number of events 69
|
|
General disorders
Asthenia
|
25.4%
34/134 • Number of events 90
|
22.8%
28/123 • Number of events 75
|
|
General disorders
Chills
|
6.7%
9/134 • Number of events 9
|
8.9%
11/123 • Number of events 11
|
|
General disorders
Fatigue
|
36.6%
49/134 • Number of events 100
|
36.6%
45/123 • Number of events 106
|
|
General disorders
Mucosal inflammation
|
20.1%
27/134 • Number of events 47
|
14.6%
18/123 • Number of events 24
|
|
General disorders
Pain
|
6.0%
8/134 • Number of events 9
|
6.5%
8/123 • Number of events 8
|
|
General disorders
Pyrexia
|
15.7%
21/134 • Number of events 30
|
17.1%
21/123 • Number of events 28
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
6/134 • Number of events 6
|
7.3%
9/123 • Number of events 9
|
|
Investigations
Alanine aminotransferase
|
16.4%
22/134 • Number of events 30
|
5.7%
7/123 • Number of events 10
|
|
Investigations
Alanine aminotransferase increased
|
42.5%
57/134 • Number of events 87
|
26.8%
33/123 • Number of events 40
|
|
Investigations
Aspartate aminotransferase
|
16.4%
22/134 • Number of events 29
|
5.7%
7/123 • Number of events 7
|
|
Investigations
Aspartate aminotransferase increased
|
40.3%
54/134 • Number of events 80
|
23.6%
29/123 • Number of events 32
|
|
Investigations
Blood alkaline phosphatase increased
|
3.7%
5/134 • Number of events 5
|
5.7%
7/123 • Number of events 11
|
|
Investigations
Blood glucose increased
|
8.2%
11/134 • Number of events 25
|
4.9%
6/123 • Number of events 13
|
|
Investigations
Blood lactate dehydrogenase increased
|
19.4%
26/134 • Number of events 33
|
12.2%
15/123 • Number of events 23
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.0%
8/134 • Number of events 11
|
5.7%
7/123 • Number of events 8
|
|
Investigations
Haemoglobin
|
6.7%
9/134 • Number of events 11
|
4.9%
6/123 • Number of events 7
|
|
Investigations
Haemoglobin decreased
|
23.9%
32/134 • Number of events 83
|
30.9%
38/123 • Number of events 86
|
|
Investigations
Neutrophil count
|
6.7%
9/134 • Number of events 21
|
3.3%
4/123 • Number of events 9
|
|
Investigations
Neutrophil count decreased
|
11.2%
15/134 • Number of events 38
|
7.3%
9/123 • Number of events 21
|
|
Investigations
Neutrophil count increased
|
7.5%
10/134 • Number of events 22
|
9.8%
12/123 • Number of events 23
|
|
Investigations
Platelet count increased
|
6.0%
8/134 • Number of events 11
|
4.1%
5/123 • Number of events 6
|
|
Investigations
Red blood cell count decreased
|
5.2%
7/134 • Number of events 9
|
3.3%
4/123 • Number of events 7
|
|
Investigations
White blood cell count
|
7.5%
10/134 • Number of events 18
|
4.9%
6/123 • Number of events 15
|
|
Investigations
White blood cell count decreased
|
9.7%
13/134 • Number of events 28
|
6.5%
8/123 • Number of events 19
|
|
Investigations
White blood cell count increased
|
9.0%
12/134 • Number of events 23
|
9.8%
12/123 • Number of events 22
|
|
Metabolism and nutrition disorders
Anorexia
|
16.4%
22/134 • Number of events 34
|
20.3%
25/123 • Number of events 47
|
|
Metabolism and nutrition disorders
Fluid retention
|
14.9%
20/134 • Number of events 23
|
11.4%
14/123 • Number of events 16
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.0%
12/134 • Number of events 21
|
6.5%
8/123 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.4%
26/134 • Number of events 56
|
22.8%
28/123 • Number of events 59
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.9%
16/134 • Number of events 16
|
13.0%
16/123 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.0%
8/134 • Number of events 14
|
8.1%
10/123 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.2%
19/134 • Number of events 23
|
17.1%
21/123 • Number of events 30
|
|
Nervous system disorders
Dizziness
|
4.5%
6/134 • Number of events 9
|
6.5%
8/123 • Number of events 9
|
|
Nervous system disorders
Dysgeusia
|
14.9%
20/134 • Number of events 27
|
21.1%
26/123 • Number of events 37
|
|
Nervous system disorders
Headache
|
9.0%
12/134 • Number of events 14
|
16.3%
20/123 • Number of events 26
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.2%
15/134 • Number of events 25
|
9.8%
12/123 • Number of events 18
|
|
Nervous system disorders
Polyneuropathy
|
18.7%
25/134 • Number of events 32
|
19.5%
24/123 • Number of events 31
|
|
Psychiatric disorders
Insomnia
|
5.2%
7/134 • Number of events 9
|
2.4%
3/123 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
7/134 • Number of events 10
|
9.8%
12/123 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
5/134 • Number of events 5
|
6.5%
8/123 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
59.7%
80/134 • Number of events 88
|
55.3%
68/123 • Number of events 75
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.2%
7/134 • Number of events 8
|
7.3%
9/123 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.2%
19/134 • Number of events 31
|
13.8%
17/123 • Number of events 29
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
28.4%
38/134 • Number of events 47
|
28.5%
35/123 • Number of events 45
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
10.4%
14/134 • Number of events 17
|
10.6%
13/123 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
11/134 • Number of events 11
|
11.4%
14/123 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.4%
14/134 • Number of events 14
|
3.3%
4/123 • Number of events 6
|
|
Vascular disorders
Hot flush
|
4.5%
6/134 • Number of events 7
|
9.8%
12/123 • Number of events 12
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60