Trial Outcomes & Findings for A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients (NCT NCT00190671)
NCT ID: NCT00190671
Last Updated: 2009-11-20
Results Overview
Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
103 participants
Primary outcome timeframe
baseline to measured progressive disease
Results posted on
2009-11-20
Participant Flow
This was a Phase 1/2 study. Phase 1 determined the doses to use in the Phase 2 portion. In this 2-stage Simon's optimal design study, enrollment in the 600 mg/m2 arm was stopped at the end of Stage 1 because of lack of efficacy; ongoing patients were allowed to continue treatment. Secondary efficacy endpoints were evaluated for 1800 mg/m2 arm only.
Participant milestones
| Measure |
Pemetrexed 600mg/m2
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
61
|
|
Overall Study
COMPLETED
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
27
|
42
|
Reasons for withdrawal
| Measure |
Pemetrexed 600mg/m2
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Overall Study
Satisfactory Response
|
4
|
7
|
|
Overall Study
Lack of Efficacy
|
19
|
24
|
|
Overall Study
Death from Study Disease
|
1
|
1
|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Clinical Relapse
|
0
|
1
|
|
Overall Study
Death from Study-Drug Toxicity
|
0
|
2
|
|
Overall Study
Death from Other Causes
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Pemetrexed 600mg/m2
n=42 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
n=61 Participants
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.0 years
n=5 Participants
|
56.0 years
n=7 Participants
|
58.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
103.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22.0 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4.0 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20.0 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18.0 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
11 participants
n=7 Participants
|
14.0 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
8 participants
n=5 Participants
|
17 participants
n=7 Participants
|
25.0 participants
n=5 Participants
|
|
Estrogen-Receptor Status
Positive
|
22 participants
n=5 Participants
|
27 participants
n=7 Participants
|
49.0 participants
n=5 Participants
|
|
Estrogen-Receptor Status
Negative
|
10 participants
n=5 Participants
|
21 participants
n=7 Participants
|
31.0 participants
n=5 Participants
|
|
Estrogen-Receptor Status
Unknown
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11.0 participants
n=5 Participants
|
|
Estrogen-Receptor Status
Missing
|
3 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12.0 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status
Positive
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7.0 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status
Negative
|
11 participants
n=5 Participants
|
27 participants
n=7 Participants
|
38.0 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status
Unknown
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17.0 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status
Not Done
|
18 participants
n=5 Participants
|
23 participants
n=7 Participants
|
41.0 participants
n=5 Participants
|
|
Pathological Diagnosis
Inflammatory Breast Carcinoma
|
7 participant
n=5 Participants
|
10 participant
n=7 Participants
|
17.0 participant
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma of the Breast
|
17 participant
n=5 Participants
|
27 participant
n=7 Participants
|
44.0 participant
n=5 Participants
|
|
Pathological Diagnosis
Other
|
18 participant
n=5 Participants
|
24 participant
n=7 Participants
|
42.0 participant
n=5 Participants
|
|
Progesterone-Receptor Status
Positive
|
19 participants
n=5 Participants
|
25 participants
n=7 Participants
|
44.0 participants
n=5 Participants
|
|
Progesterone-Receptor Status
Negative
|
13 participants
n=5 Participants
|
23 participants
n=7 Participants
|
36.0 participants
n=5 Participants
|
|
Progesterone-Receptor Status
Unknown
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11.0 participants
n=5 Participants
|
|
Progesterone-Receptor Status
Missing
|
3 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12.0 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
42 participants
n=5 Participants
|
61 participants
n=7 Participants
|
103.0 participants
n=5 Participants
|
|
World Health Organization Performance Status
0 - Asymptomatic, fully active
|
18 participants
n=5 Participants
|
40 participants
n=7 Participants
|
58.0 participants
n=5 Participants
|
|
World Health Organization Performance Status
1 - Symptomatic, fully ambulatory, light activity
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40.0 participants
n=5 Participants
|
|
World Health Organization Performance Status
2 - Symptomatic, ambulatory, no work activities
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5.0 participants
n=5 Participants
|
|
Body Surface Area
|
1.8 square meters
n=5 Participants
|
1.7 square meters
n=7 Participants
|
1.7 square meters
n=5 Participants
|
|
Height
|
160.0 centimeters
n=5 Participants
|
160.0 centimeters
n=7 Participants
|
160.0 centimeters
n=5 Participants
|
|
Weight
|
71.5 kilograms
n=5 Participants
|
70.0 kilograms
n=7 Participants
|
70.0 kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive diseasePopulation: Number of randomized participants.
Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.
Outcome measures
| Measure |
Pemetrexed 600mg/m2
n=42 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
n=61 Participants
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Best Tumor Response
Complete Response
|
0 participants
|
0 participants
|
|
Best Tumor Response
Partial Response
|
8 participants
|
20 participants
|
|
Best Tumor Response
Stable Disease
|
18 participants
|
26 participants
|
|
Best Tumor Response
Progressive Disease
|
13 participants
|
8 participants
|
|
Best Tumor Response
Unknown
|
3 participants
|
5 participants
|
|
Best Tumor Response
Not Assessed
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: baseline to measured progressive diseasePopulation: All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). Time to disease progression was censored for 26 (42.6%) participants.
Time to progressive disease was defined as the time from the date of the first treatment dose to the first date of progressive disease or death from study disease.
Outcome measures
| Measure |
Pemetrexed 600mg/m2
n=61 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Time to Progressive Disease
|
6.56 months
Interval 5.21 to 10.92
|
—
|
SECONDARY outcome
Timeframe: baseline to measured progressive diseasePopulation: All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). The Progression Free Survival date was censored for 22 (35.07%) participants.
Defined as date of first treatment dose to first date of progressive disease or death from any cause. For patients not known to have died as of data cutoff date and who did not have progressive disease, the progression free survival date was censored at last contact date.
Outcome measures
| Measure |
Pemetrexed 600mg/m2
n=61 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Progression Free Survival
|
6.26 months
Interval 4.56 to 10.46
|
—
|
SECONDARY outcome
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)Population: Number of participants included in the pharmacokinetic analyses.
Outcome measures
| Measure |
Pemetrexed 600mg/m2
n=5 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
n=9 Participants
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Pharmacokinetics - Maximum Observed Drug Concentration (Cmax)
|
125 micrograms per milliliters
Full Range 15 • Interval 112.0 to 158.0
|
369 micrograms per milliliters
Full Range 14 • Interval 301.0 to 494.0
|
SECONDARY outcome
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)Population: Number of participants included in the pharmacokinetic analyses.
Area under the gemcitabine concentration-time curve from zero to last quantifiable concentration \[AUC(0-t)\] was calculated by combination of linear and logarithmic trapezoidal methods. Linear trapezoidal method was employed up to tmax (time to reach maximal concentration), and then log trapezoidal method was used for those data after tmax.
Outcome measures
| Measure |
Pemetrexed 600mg/m2
n=5 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
n=9 Participants
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Pharmacokinetics - Area Under the Curve (AUC)
|
375 hour times microgram per milliliter
Full Range 13 • Interval 301.0 to 417.0
|
1050 hour times microgram per milliliter
Full Range 17 • Interval 877.0 to 1560.0
|
SECONDARY outcome
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)Population: Number of participants included in the pharmacokinetic analyses.
Total body clearance of drug calculated after intravenous administration.
Outcome measures
| Measure |
Pemetrexed 600mg/m2
n=5 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
n=9 Participants
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Pharmacokinetics - Clearance (CL)
|
45.9 milliliters per minute
Full Range 15 • Interval 35.9 to 52.5
|
51.8 milliliters per minute
Full Range 27 • Interval 29.0 to 74.3
|
SECONDARY outcome
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)Population: Number of participants included in the pharmacokinetic analyses.
Central volume (V1) and peripheral volume (V2) of distribution.
Outcome measures
| Measure |
Pemetrexed 600mg/m2
n=5 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
n=9 Participants
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Pharmacokinetics - Volume of Distribution
Central Volume of Distribution (V1)
|
7.46 Liters
Full Range 16 • Interval 5.87 to 9.05
|
8.14 Liters
Full Range 25 • Interval 5.05 to 11.4
|
|
Pharmacokinetics - Volume of Distribution
Peripheral Volume of Distribution (V2)
|
3.58 Liters
Full Range 37 • Interval 1.95 to 4.79
|
3.33 Liters
Full Range 16 • Interval 2.51 to 4.37
|
SECONDARY outcome
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)Population: Number of participants included in the pharmacokinetic analyses.
The half-life associated with the terminal elimination rate constant.
Outcome measures
| Measure |
Pemetrexed 600mg/m2
n=5 Participants
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
n=9 Participants
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Pharmacokinetics - Half-Life (t½)
|
4.19 hours
Interval 2.51 to 5.32
|
3.79 hours
Interval 3.09 to 4.17
|
Adverse Events
Pemetrexed 600mg/m2
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
Pemetrexed 1800mg/m2
Serious events: 13 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed 600mg/m2
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
2/42 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/61
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/42
|
3.3%
2/61 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/42 • Number of events 2
|
3.3%
2/61 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
1/42 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
2.4%
1/42 • Number of events 1
|
0.00%
0/61
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Oedema
|
2.4%
1/42 • Number of events 1
|
0.00%
0/61
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Joint abscess
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Body temperature increased
|
0.00%
0/42
|
1.6%
1/61 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/42 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
2/42 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/42 • Number of events 1
|
0.00%
0/61
|
Other adverse events
| Measure |
Pemetrexed 600mg/m2
Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
Pemetrexed 1800mg/m2
Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
|
|---|---|---|
|
Investigations
White blood cell count decreased
|
9.5%
4/42 • Number of events 11
|
3.3%
2/61 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/42
|
11.5%
7/61 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/42
|
11.5%
7/61 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.5%
4/42 • Number of events 4
|
11.5%
7/61 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/42
|
9.8%
6/61 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
3/42 • Number of events 4
|
24.6%
15/61 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/42
|
6.6%
4/61 • Number of events 4
|
|
Vascular disorders
Hypertension
|
7.1%
3/42 • Number of events 4
|
4.9%
3/61 • Number of events 4
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
3/42 • Number of events 3
|
16.4%
10/61 • Number of events 13
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.0%
8/42 • Number of events 24
|
31.1%
19/61 • Number of events 36
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
6/42 • Number of events 6
|
6.6%
4/61 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.2%
11/42 • Number of events 27
|
34.4%
21/61 • Number of events 51
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
3/42 • Number of events 4
|
9.8%
6/61 • Number of events 9
|
|
Eye disorders
Conjunctivitis
|
4.8%
2/42 • Number of events 3
|
11.5%
7/61 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
4/42 • Number of events 5
|
11.5%
7/61 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
3/42 • Number of events 3
|
3.3%
2/61 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
9.5%
4/42 • Number of events 4
|
4.9%
3/61 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
7/42 • Number of events 10
|
13.1%
8/61 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
50.0%
21/42 • Number of events 57
|
50.8%
31/61 • Number of events 79
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
1/42 • Number of events 1
|
24.6%
15/61 • Number of events 33
|
|
Gastrointestinal disorders
Vomiting
|
31.0%
13/42 • Number of events 34
|
34.4%
21/61 • Number of events 44
|
|
General disorders
Adverse drug reaction
|
0.00%
0/42
|
6.6%
4/61 • Number of events 5
|
|
General disorders
Asthenia
|
21.4%
9/42 • Number of events 10
|
11.5%
7/61 • Number of events 9
|
|
General disorders
Fatigue
|
26.2%
11/42 • Number of events 25
|
32.8%
20/61 • Number of events 44
|
|
General disorders
Mucosal inflammation
|
4.8%
2/42 • Number of events 2
|
9.8%
6/61 • Number of events 9
|
|
General disorders
Oedema peripheral
|
7.1%
3/42 • Number of events 4
|
4.9%
3/61 • Number of events 4
|
|
General disorders
Pyrexia
|
11.9%
5/42 • Number of events 5
|
8.2%
5/61 • Number of events 6
|
|
Immune system disorders
Hypersensitivity
|
7.1%
3/42 • Number of events 3
|
0.00%
0/61
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42 • Number of events 3
|
4.9%
3/61 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
7/42 • Number of events 9
|
21.3%
13/61 • Number of events 20
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
6/42 • Number of events 7
|
24.6%
15/61 • Number of events 19
|
|
Investigations
Blood alkaline phosphatase increased
|
21.4%
9/42 • Number of events 10
|
3.3%
2/61 • Number of events 2
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.1%
3/42 • Number of events 3
|
4.9%
3/61 • Number of events 3
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
3/42 • Number of events 3
|
3.3%
2/61 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
14.3%
6/42 • Number of events 11
|
9.8%
6/61 • Number of events 11
|
|
Investigations
Neutrophil count decreased
|
9.5%
4/42 • Number of events 12
|
9.8%
6/61 • Number of events 16
|
|
Investigations
Platelet count decreased
|
7.1%
3/42 • Number of events 3
|
6.6%
4/61 • Number of events 5
|
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