Trial Outcomes & Findings for Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer (NCT NCT00334802)
NCT ID: NCT00334802
Last Updated: 2010-03-16
Results Overview
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
baseline to measured progressive disease
Results posted on
2010-03-16
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
56
|
|
Overall Study
COMPLETED
|
0
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
40
|
Reasons for withdrawal
| Measure |
Dose Level 1
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Overall Study
Progressive Disease
|
2
|
24
|
|
Overall Study
Toxicity
|
1
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
|
Overall Study
Patient Condition Aggrevated
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Criteria for Starting Next Cycle Not Met
|
0
|
1
|
Baseline Characteristics
Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=6 Participants
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
n=56 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.2 years
STANDARD_DEVIATION 4.49 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 8.73 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
6 participants
n=5 Participants
|
56 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Age at Primary Diagnosis
<30 years old
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age at Primary Diagnosis
30 to <40 years old
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age at Primary Diagnosis
40 to <50 years old
|
1 participants
n=5 Participants
|
20 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Age at Primary Diagnosis
50 to <60 years old
|
3 participants
n=5 Participants
|
24 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Age at Primary Diagnosis
60 to <70 years old
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Age at Primary Diagnosis
≥70 years old
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
4 participants
n=5 Participants
|
50 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Body Weight
|
57.18 kilograms
STANDARD_DEVIATION 15.313 • n=5 Participants
|
55.76 kilograms
STANDARD_DEVIATION 8.715 • n=7 Participants
|
55.90 kilograms
STANDARD_DEVIATION 9.375 • n=5 Participants
|
|
Height
|
153.53 centimeters
STANDARD_DEVIATION 7.987 • n=5 Participants
|
154.71 centimeters
STANDARD_DEVIATION 6.184 • n=7 Participants
|
154.60 centimeters
STANDARD_DEVIATION 6.312 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive diseaseBest response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response.
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
n=56 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Tumor Response
Complete Response
|
0 participants
|
0 participants
|
|
Tumor Response
Partial Response
|
3 participants
|
25 participants
|
|
Tumor Response
Stable Disease
|
1 participants
|
17 participants
|
|
Tumor Response
Progressive Disease
|
1 participants
|
11 participants
|
|
Tumor Response
Not Evaluable
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: time of response to progressive diseaseThe duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Outcome measures
| Measure |
Dose Level 1
n=56 Participants
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Duration of Response
|
4.70 months
Interval 1.2 to 7.3
|
—
|
SECONDARY outcome
Timeframe: baseline to measured progressive diseaseDefined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
n=56 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Time to Progressive Disease
|
310.5 days
Interval 42.0 to 455.0
|
194.0 days
Interval 29.0 to 265.0
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause, evaluated at 1 yearOutcome measures
| Measure |
Dose Level 1
n=6 Participants
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
n=56 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Number of Participants Alive at One Year (1-Year Survival)
|
5 participants
|
45 participants
|
SECONDARY outcome
Timeframe: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)Population: Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.
Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.
Outcome measures
| Measure |
Dose Level 1
n=12 Participants
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
n=12 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Pharmacokinetics - Maximum Plasma Concentration (Cmax)
|
25800 nanograms per milliliter (ng/mL)
Interval 12800.0 to 43600.0
|
25400 nanograms per milliliter (ng/mL)
Interval 20000.0 to 33100.0
|
SECONDARY outcome
Timeframe: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)Population: Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.
Area under the concentration curve from time zero to infinity.
Outcome measures
| Measure |
Dose Level 1
n=12 Participants
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
n=12 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Pharmacokinetics - Area Under the Concentration Curve (AUC)
|
16300 nanograms*hour per milliliter (ng*hr/mL)
Interval 11700.0 to 25500.0
|
14700 nanograms*hour per milliliter (ng*hr/mL)
Interval 11500.0 to 21000.0
|
SECONDARY outcome
Timeframe: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)Population: Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.
Apparent elimination half-life.
Outcome measures
| Measure |
Dose Level 1
n=12 Participants
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
n=12 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Pharmacokinetics - Half Life (t½)
|
0.282 hours
Interval 0.192 to 1.0
|
0.258 hours
Interval 0.162 to 0.969
|
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 3 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Investigations
Haemoglobin decreased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
Other adverse events
| Measure |
Dose Level 1
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
Dose Level 2
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/6
|
1.8%
1/56 • Number of events 6
|
|
Nervous system disorders
Parosmia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6
|
1.8%
1/56 • Number of events 7
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 2
|
30.4%
17/56 • Number of events 26
|
|
Infections and infestations
Tinea infection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/56
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
16.7%
1/6 • Number of events 1
|
12.5%
7/56 • Number of events 10
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 5
|
48.2%
27/56 • Number of events 54
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1
|
23.2%
13/56 • Number of events 17
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Number of events 5
|
33.9%
19/56 • Number of events 57
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 5
|
26.8%
15/56 • Number of events 36
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
2/6 • Number of events 3
|
35.7%
20/56 • Number of events 42
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1
|
8.9%
5/56 • Number of events 7
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • Number of events 1
|
23.2%
13/56 • Number of events 18
|
|
Nervous system disorders
Sensory disturbance
|
16.7%
1/6 • Number of events 1
|
23.2%
13/56 • Number of events 13
|
|
Cardiac disorders
Palpitations
|
33.3%
2/6 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
|
Vascular disorders
Angiopathy
|
33.3%
2/6 • Number of events 3
|
44.6%
25/56 • Number of events 73
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Number of events 1
|
8.9%
5/56 • Number of events 11
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 2
|
1.8%
1/56 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1
|
17.9%
10/56 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 2
|
7.1%
4/56 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 10
|
51.8%
29/56 • Number of events 105
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 3
|
23.2%
13/56 • Number of events 63
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 2
|
28.6%
16/56 • Number of events 38
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
4/6 • Number of events 4
|
60.7%
34/56 • Number of events 34
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
2/6 • Number of events 2
|
16.1%
9/56 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 2
|
17.9%
10/56 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • Number of events 1
|
21.4%
12/56 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.7%
1/6 • Number of events 1
|
5.4%
3/56 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
16.7%
1/6 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1
|
41.1%
23/56 • Number of events 69
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Number of events 2
|
0.00%
0/56
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 2
|
10.7%
6/56 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 11
|
33.9%
19/56 • Number of events 62
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1
|
21.4%
12/56 • Number of events 31
|
|
General disorders
Malaise
|
83.3%
5/6 • Number of events 22
|
60.7%
34/56 • Number of events 116
|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Number of events 4
|
10.7%
6/56 • Number of events 10
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 3
|
28.6%
16/56 • Number of events 47
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 2
|
7.1%
4/56 • Number of events 7
|
|
General disorders
Localised oedema
|
16.7%
1/6 • Number of events 2
|
0.00%
0/56
|
|
Investigations
Alanine amiontransferase increased
|
100.0%
6/6 • Number of events 26
|
78.6%
44/56 • Number of events 155
|
|
Investigations
Haemoglobin decreased
|
100.0%
6/6 • Number of events 23
|
75.0%
42/56 • Number of events 130
|
|
Investigations
White blood cell count decreased
|
83.3%
5/6 • Number of events 40
|
92.9%
52/56 • Number of events 370
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
4/6 • Number of events 24
|
67.9%
38/56 • Number of events 133
|
|
Investigations
Lymphocyte count decreased
|
66.7%
4/6 • Number of events 22
|
50.0%
28/56 • Number of events 101
|
|
Investigations
Neutrophil count decreased
|
66.7%
4/6 • Number of events 39
|
96.4%
54/56 • Number of events 368
|
|
Investigations
Platelet count decreased
|
66.7%
4/6 • Number of events 22
|
69.6%
39/56 • Number of events 164
|
|
Investigations
Blood alkaline phosphatase increased
|
66.7%
4/6 • Number of events 7
|
25.0%
14/56 • Number of events 23
|
|
Investigations
Red blood cell count decreased
|
50.0%
3/6 • Number of events 8
|
66.1%
37/56 • Number of events 112
|
|
Investigations
Platelet count increased
|
50.0%
3/6 • Number of events 17
|
17.9%
10/56 • Number of events 33
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
2/6 • Number of events 3
|
32.1%
18/56 • Number of events 23
|
|
Investigations
Glucose urine present
|
33.3%
2/6 • Number of events 2
|
7.1%
4/56 • Number of events 11
|
|
Investigations
Haematocrit decreased
|
33.3%
2/6 • Number of events 11
|
57.1%
32/56 • Number of events 116
|
|
Investigations
Blood urine present
|
33.3%
2/6 • Number of events 3
|
14.3%
8/56 • Number of events 13
|
|
Investigations
Weight decreased
|
33.3%
2/6 • Number of events 3
|
5.4%
3/56 • Number of events 3
|
|
Investigations
Protein urine present
|
33.3%
2/6 • Number of events 5
|
14.3%
8/56 • Number of events 15
|
|
Investigations
Blood albumin decreased
|
16.7%
1/6 • Number of events 4
|
23.2%
13/56 • Number of events 25
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1
|
10.7%
6/56 • Number of events 10
|
|
Investigations
Blood calcium decreased
|
16.7%
1/6 • Number of events 4
|
3.6%
2/56 • Number of events 2
|
|
Investigations
Blood calcium increased
|
16.7%
1/6 • Number of events 2
|
3.6%
2/56 • Number of events 6
|
|
Investigations
Blood pressure increased
|
16.7%
1/6 • Number of events 1
|
7.1%
4/56 • Number of events 14
|
|
Investigations
Blood sodium decreased
|
16.7%
1/6 • Number of events 1
|
8.9%
5/56 • Number of events 9
|
|
Investigations
Leucine aminopeptidase increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Neutrophil count increased
|
16.7%
1/6 • Number of events 1
|
12.5%
7/56 • Number of events 10
|
|
Investigations
Weight increased
|
16.7%
1/6 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Investigations
White blood cell count increased
|
16.7%
1/6 • Number of events 1
|
12.5%
7/56 • Number of events 13
|
|
Injury, poisoning and procedural complications
Joint sprain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/56
|
|
Surgical and medical procedures
Cautery to nose
|
16.7%
1/6 • Number of events 2
|
0.00%
0/56
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Genital herpes
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.00%
0/6
|
1.8%
1/56 • Number of events 4
|
|
Eye disorders
Eye discharge
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/6
|
10.7%
6/56 • Number of events 13
|
|
Vascular disorders
Vasculitis
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/6
|
16.1%
9/56 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6
|
7.1%
4/56 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6
|
3.6%
2/56 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/6
|
3.6%
2/56 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
23.2%
13/56 • Number of events 27
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/6
|
8.9%
5/56 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6
|
7.1%
4/56 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
5.4%
3/56 • Number of events 5
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6
|
3.6%
2/56 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
3.6%
2/56 • Number of events 5
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6
|
3.6%
2/56 • Number of events 4
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6
|
1.8%
1/56 • Number of events 5
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6
|
28.6%
16/56 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/6
|
7.1%
4/56 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6
|
3.6%
2/56 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6
|
3.6%
2/56 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6
|
7.1%
4/56 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6
|
5.4%
3/56 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/6
|
3.6%
2/56 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
Residual urine
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Renal and urinary disorders
Cystitis-like symptom
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/6
|
12.5%
7/56 • Number of events 15
|
|
General disorders
Face oedema
|
0.00%
0/6
|
8.9%
5/56 • Number of events 9
|
|
General disorders
Pain
|
0.00%
0/6
|
8.9%
5/56 • Number of events 8
|
|
General disorders
Chest discomfort
|
0.00%
0/6
|
7.1%
4/56 • Number of events 4
|
|
General disorders
Oedema
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
General disorders
Thirst
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Feeling abnormal
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Feeling drunk
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Generalised oedema
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Hangover
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Injection site reaction
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Local swelling
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6
|
17.9%
10/56 • Number of events 23
|
|
Investigations
Protein total decreased
|
0.00%
0/6
|
16.1%
9/56 • Number of events 21
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6
|
12.5%
7/56 • Number of events 24
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6
|
10.7%
6/56 • Number of events 7
|
|
Investigations
Blood urea decreased
|
0.00%
0/6
|
10.7%
6/56 • Number of events 10
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6
|
7.1%
4/56 • Number of events 8
|
|
Investigations
Blood chloride decreased
|
0.00%
0/6
|
5.4%
3/56 • Number of events 4
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/6
|
5.4%
3/56 • Number of events 6
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6
|
5.4%
3/56 • Number of events 3
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6
|
3.6%
2/56 • Number of events 7
|
|
Investigations
Blood glucose increased
|
0.00%
0/6
|
3.6%
2/56 • Number of events 7
|
|
Investigations
Blood potassium increased
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Investigations
Blood urea increased
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Investigations
Creatine phosphokinase decreased
|
0.00%
0/6
|
3.6%
2/56 • Number of events 4
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Aspartate aminotransferase decreased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Investigations
Blood cholinesterase increased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Blood sodium increased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Haematocrit increased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/6
|
1.8%
1/56 • Number of events 3
|
|
Investigations
Urobilin urine present
|
0.00%
0/6
|
1.8%
1/56 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
3.6%
2/56 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6
|
3.6%
2/56 • Number of events 2
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/6
|
1.8%
1/56 • Number of events 3
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/6
|
7.1%
4/56 • Number of events 4
|
|
Surgical and medical procedures
Catheterisation venous
|
0.00%
0/6
|
1.8%
1/56 • Number of events 1
|
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