Trial Outcomes & Findings for Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer (NCT NCT00191789)
NCT ID: NCT00191789
Last Updated: 2010-07-27
Results Overview
Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
tumor assessment at baseline and during surgery after eight 21-day treatment cycles
Results posted on
2010-07-27
Participant Flow
Participant milestones
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Patient: Satisfactory Response
|
5
|
|
Overall Study
Patient/Physician: Satisfactory Response
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death - Possibly Study Drug Related
|
4
|
|
Overall Study
Progressive Disease/Lack of Efficacy
|
2
|
|
Overall Study
Death - Not Study-Drug Related
|
1
|
Baseline Characteristics
Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 Participants
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Age Continuous
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
65 participants
n=5 Participants
|
|
Region of Enrollment
India
|
65 participants
n=5 Participants
|
|
Diagnosis
Histopathological
|
12 participants
n=5 Participants
|
|
Diagnosis
Cytological
|
53 participants
n=5 Participants
|
|
Disease Stage
Stage IIA
|
3 participants
n=5 Participants
|
|
Disease Stage
Stage IIB
|
30 participants
n=5 Participants
|
|
Disease Stage
Stage IIIA
|
18 participants
n=5 Participants
|
|
Disease Stage
Stage IIIB
|
14 participants
n=5 Participants
|
|
Hormone Receptor Status
ER+ / PR+
|
27 participants
n=5 Participants
|
|
Hormone Receptor Status
ER+ / PR-
|
8 participants
n=5 Participants
|
|
Hormone Receptor Status
ER- / PR+
|
3 participants
n=5 Participants
|
|
Hormone Receptor Status
ER- / PR-
|
25 participants
n=5 Participants
|
|
Hormone Receptor Status
No Assessment
|
2 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2) Status
0
|
27 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2) Status
1+
|
8 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2) Status
2+
|
2 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2) Status
3+
|
19 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2) Status
Not Detected
|
7 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2) Status
Insufficient Sample
|
2 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
100 - Normal no complaints; no evidence of disease
|
9 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
90 - Normal activity; minor signs of disease
|
56 participants
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
29 participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
36 participants
n=5 Participants
|
|
Body Surface Area
|
1.44 meters squared (m^2)
n=5 Participants
|
|
Height
|
153 centimeters (cm)
n=5 Participants
|
|
Largest Lesion Size
|
30 millimeters (mm)
n=5 Participants
|
|
Weight
|
57 kilograms (kg)
n=5 Participants
|
PRIMARY outcome
Timeframe: tumor assessment at baseline and during surgery after eight 21-day treatment cyclesPopulation: Intent to treat population.
Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.
Outcome measures
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 Participants
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)
|
13 participants
|
SECONDARY outcome
Timeframe: baseline through last cycle on study drug (eight 21-day cycles)Population: Intent to treat population.
Outcome measures
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 Participants
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Summary of Deaths During Study
Study Disease
|
0 participants
|
|
Summary of Deaths During Study
Study Drug Toxicity: Cardiac arrest
|
1 participants
|
|
Summary of Deaths During Study
Study Drug Toxicity: Infection with neutropenia
|
1 participants
|
|
Summary of Deaths During Study
Study Drug Toxicity: Neutropenic sepsis
|
2 participants
|
|
Summary of Deaths During Study
Myocardial infarction
|
1 participants
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease or death from any cause (up to 68 months)Population: Median was not reached.
PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause. Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to date of death from any cause up to 68 monthsPopulation: Median was not reached
Overall survival was defined as the date of enrollment to the date of death from any cause. Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to stopping treatment (up to 68 months)Population: Upper limit of 95% Confidence Interval of median survival was not calculable.
Time to treatment failure was defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, after eight 21-day cycles of study drugThe extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery.
Outcome measures
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 Participants
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery
Eligible for Surgery at Baseline
|
0 participiants
|
|
Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery
Underwent Surgery
|
18 participiants
|
POST_HOC outcome
Timeframe: baseline up to 68 monthsPopulation: Intent to treat population.
The cumulative number of participants with an event (either progressive disease or death) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without progressive disease or still alive at the beginning of each time point.
Outcome measures
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 Participants
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
3 Months: Number of Patients with Event
|
5 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
3 Months: Number of Patients at Risk
|
59 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
6 Months: Number of Patients with Event
|
8 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
6 Months: Number of Patients at Risk
|
50 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
12 Months: Number of Patients with Event
|
11 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
12 Months: Number of Patients at Risk
|
41 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
24 Months: Number of Patients with Event
|
15 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
24 Months: Number of Patients at Risk
|
36 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
48 Months: Number of Patients with Event
|
21 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
48 Months: Number of Patients at Risk
|
23 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
68 Months: Number of Patients with Event
|
21 participants
|
|
Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
68 Months: Number of Patients at Risk
|
1 participants
|
POST_HOC outcome
Timeframe: baseline up to 68 monthsPopulation: Intent to treat population.
The cumulative number of participants with an event (death from any cause) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants still alive at the beginning of each time point.
Outcome measures
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 Participants
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Number of Participants Who Died From Any Cause at Various Time Points
3 Months: Number of Patients With Event
|
3 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
3 Months: Number of Patients at Risk
|
60 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
6 Months: Number of Patients With Event
|
5 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
6 Months: Number of Patients at Risk
|
51 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
12 Months: Number of Patients With Event
|
7 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
12 Months: Number of Patients at Risk
|
43 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
26 Months: Number of Patients With Event
|
11 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
26 Months: Number of Patients at Risk
|
37 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
48 Months: Number of Patients With Event
|
14 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
48 Months: Number of Patients at Risk
|
24 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
68 Months: Number of Patients With Event
|
15 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
68 Months: Number of Patients at Risk
|
1 participants
|
POST_HOC outcome
Timeframe: baseline to stopping treatment (up to 68 months)Population: Intent to treat population.
This outcome is in place of the time to treatment failure outcome. The cumulative number of participants with an event (disease progression, death as a result of any cause, or early discontinuation of treatment) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without disease progression, are alive, or did not discontinue treatment early at the beginning of each time point.
Outcome measures
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 Participants
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Number of Participants With Time to Treatment Failure at Various Time Points
3 Months: Number of Patients with Event
|
11 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
3 Months: Number of Patients at Risk
|
59 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
6 Months: Number of Patients with Event
|
19 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
6 Months: Number of Patients at Risk
|
50 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
12 Months: Number of Patients with Event
|
25 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
12 Months: Number of Patients at Risk
|
41 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
24 Months: Number of Patients with Event
|
29 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
24 Months: Number of Patients at Risk
|
36 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
48 Months: Number of Patients with Event
|
35 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
48 Months: Number of Patients at Risk
|
23 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
68 Months: Number of Patients with Event
|
35 participants
|
|
Number of Participants With Time to Treatment Failure at Various Time Points
68 Months: Number of Patients at Risk
|
1 participants
|
Adverse Events
Gemcitabine+Doxorubicin+Cisplatin+Surgery
Serious events: 17 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 participants at risk
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.6%
3/65 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
2/65 • Number of events 2
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.5%
1/65 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
2/65 • Number of events 2
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
5/65 • Number of events 6
|
|
Gastrointestinal disorders
Stomatitis
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/65 • Number of events 2
|
|
General disorders
Fatigue
|
1.5%
1/65 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Neutropenic infection
|
3.1%
2/65 • Number of events 2
|
|
Infections and infestations
Neutropenic sepsis
|
9.2%
6/65 • Number of events 6
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Sepsis
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
1.5%
1/65 • Number of events 2
|
Other adverse events
| Measure |
Gemcitabine+Doxorubicin+Cisplatin+Surgery
n=65 participants at risk
Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
87.7%
57/65 • Number of events 75
|
|
Blood and lymphatic system disorders
Leukopenia
|
64.6%
42/65 • Number of events 81
|
|
Blood and lymphatic system disorders
Neutropenia
|
69.2%
45/65 • Number of events 148
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.2%
17/65 • Number of events 21
|
|
Gastrointestinal disorders
Abdominal pain
|
10.8%
7/65 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/65 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
12.3%
8/65 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
6.2%
4/65 • Number of events 4
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
13/65 • Number of events 16
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
13/65 • Number of events 17
|
|
General disorders
Asthenia
|
16.9%
11/65 • Number of events 14
|
|
General disorders
Fatigue
|
23.1%
15/65 • Number of events 16
|
|
General disorders
Pyrexia
|
10.8%
7/65 • Number of events 7
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
26/65 • Number of events 33
|
|
Investigations
Aspartate aminotransferase increased
|
41.5%
27/65 • Number of events 32
|
|
Investigations
Blood alkaline phosphatase increased
|
13.8%
9/65 • Number of events 12
|
|
Investigations
Blood creatinine increased
|
7.7%
5/65 • Number of events 5
|
|
Investigations
Weight decreased
|
15.4%
10/65 • Number of events 11
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
5/65 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
13.8%
9/65 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
13/65 • Number of events 17
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.8%
7/65 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.2%
6/65 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
26/65 • Number of events 26
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60