Trial Outcomes & Findings for Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim (NCT NCT01519700)
NCT ID: NCT01519700
Last Updated: 2015-05-06
Results Overview
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5\*10\^9 cells/L)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
218 participants
Primary outcome timeframe
21 days (Cycle 1 of chemotherapy treatment)
Results posted on
2015-05-06
Participant Flow
The study population consisted of women of 18 years or older with histologically proven breast cancer who were eligible for neoadjuvant or adjuvant treatment with TAC chemotherapy. The study was aimed to randomize a total of 192 patients in approximately 65 centers worldwide.
The study started with a screening period of up to 21 days. During the screening period, the eligibility of the patients to participate in the study was assessed based on safety evaluations. After completion of the screening period, the patients were randomized to either EP2006 or US-licensed Neupogen® in four groups (see below).
Participant milestones
| Measure |
EP2006
Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously
|
EP2006 + Neupogen
Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously
|
Neupogen + EP2006
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously
|
Neupogen
Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
55
|
55
|
54
|
|
Overall Study
Treated Cycle 1 EP2006
|
53
|
54
|
0
|
0
|
|
Overall Study
Treated Cycle 1 Neupogen
|
0
|
0
|
55
|
52
|
|
Overall Study
Treated Cycle 2 EP2006
|
52
|
0
|
55
|
0
|
|
Overall Study
Treated Cycle 2 Neupogen
|
0
|
52
|
0
|
51
|
|
Overall Study
Treated Cycle 3 EP2006
|
51
|
51
|
0
|
0
|
|
Overall Study
Treated Cycle 3 Neupogen
|
0
|
0
|
54
|
51
|
|
Overall Study
Treated Cycle 4 EP2006
|
51
|
0
|
50
|
0
|
|
Overall Study
Treated Cycle 4 Neupogen
|
0
|
51
|
0
|
50
|
|
Overall Study
Treated Cycle 5 EP2006
|
46
|
49
|
0
|
0
|
|
Overall Study
Treated Cycle 5 Neupogen
|
0
|
0
|
48
|
50
|
|
Overall Study
Treated Cycle 6 EP2006
|
45
|
0
|
48
|
0
|
|
Overall Study
Treated Cycle 6 Neupogen
|
0
|
49
|
0
|
49
|
|
Overall Study
COMPLETED
|
45
|
49
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
7
|
7
|
Reasons for withdrawal
| Measure |
EP2006
Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously
|
EP2006 + Neupogen
Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously
|
Neupogen + EP2006
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously
|
Neupogen
Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
3
|
2
|
|
Overall Study
Other Reason
|
2
|
2
|
0
|
4
|
Baseline Characteristics
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
Baseline characteristics by cohort
| Measure |
EP2006
n=53 Participants
Patients remained on EP2006 (their initial treatment) throughout the study
|
EP2006 + Neupogen
n=54 Participants
Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
|
Neupogen + EP2006
n=55 Participants
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
n=52 Participants
Patients remained on Neupogen (their initial treatment) throughout the study
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 11.64 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 10.91 • n=4 Participants
|
48.9 years
STANDARD_DEVIATION 11.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
214 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 21 days (Cycle 1 of chemotherapy treatment)Population: PP population
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5\*10\^9 cells/L)
Outcome measures
| Measure |
EP2006 + EP2006 & Neupogen
n=101 Participants
All subjects randomized to receive either EP2006 in Cycle 1
|
Neupogen + Neupogen & EP2006
n=103 Participants
All subjects randomized to receive Neupogen in Cycle 1
|
Neupogen + EP2006
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
Patients remained on Neupogen (their initial treatment) throughout the study
|
Total
All patients
|
|---|---|---|---|---|---|
|
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
|
1.17 Days
Standard Deviation 1.11
|
1.2 Days
Standard Deviation 1.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 weeks/ 6 cyclesPopulation: SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.
Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count \< 0.5\*10\^9 cells/L (both measured on the same day)
Outcome measures
| Measure |
EP2006 + EP2006 & Neupogen
n=52 Participants
All subjects randomized to receive either EP2006 in Cycle 1
|
Neupogen + Neupogen & EP2006
n=52 Participants
All subjects randomized to receive Neupogen in Cycle 1
|
Neupogen + EP2006
n=55 Participants
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
n=51 Participants
Patients remained on Neupogen (their initial treatment) throughout the study
|
Total
n=210 Participants
All patients
|
|---|---|---|---|---|---|
|
Incidence of Febrile Neutropenia
Cycle 1 - 0 Days duration
|
50 participants
|
49 participants
|
54 participants
|
51 participants
|
204 participants
|
|
Incidence of Febrile Neutropenia
Cycle 1 - 1 Day duration
|
2 participants
|
3 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Incidence of Febrile Neutropenia
Cycle 1 - 2 Days duration
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Incidence of Febrile Neutropenia
Cycle 2 - 0 Days duration
|
52 participants
|
51 participants
|
55 participants
|
51 participants
|
209 participants
|
|
Incidence of Febrile Neutropenia
Cycle 2 - 1 Day duration
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Febrile Neutropenia
Cycle 3 - 0 Days duration
|
51 participants
|
51 participants
|
54 participants
|
51 participants
|
207 participants
|
|
Incidence of Febrile Neutropenia
Cycle 4 - 0 Days duration
|
51 participants
|
51 participants
|
50 participants
|
50 participants
|
202 participants
|
|
Incidence of Febrile Neutropenia
Cycle 5 - 0 Days duration
|
45 participants
|
48 participants
|
48 participants
|
50 participants
|
191 participants
|
|
Incidence of Febrile Neutropenia
Cycle 5 - 1 Day duration
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Febrile Neutropenia
Cycle 6 - 0 Days duration
|
43 participants
|
48 participants
|
48 participants
|
49 participants
|
188 participants
|
|
Incidence of Febrile Neutropenia
Cycle 6 - 1 Day duration
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Febrile Neutropenia
All Cycles - 0 Days duration
|
49 participants
|
46 participants
|
54 participants
|
51 participants
|
200 participants
|
|
Incidence of Febrile Neutropenia
All Cycles - 1 Day duration
|
3 participants
|
6 participants
|
0 participants
|
0 participants
|
9 participants
|
|
Incidence of Febrile Neutropenia
All Cycles - 2 Days duration
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 21 weeks/ 6 cyclesPopulation: PP-I (alternating Per-Protocol) set: randomized patients who completed all six chemotherapy cycles without major protocol violations.
Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.
Outcome measures
| Measure |
EP2006 + EP2006 & Neupogen
n=40 Participants
All subjects randomized to receive either EP2006 in Cycle 1
|
Neupogen + Neupogen & EP2006
n=45 Participants
All subjects randomized to receive Neupogen in Cycle 1
|
Neupogen + EP2006
n=44 Participants
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
n=46 Participants
Patients remained on Neupogen (their initial treatment) throughout the study
|
Total
n=175 Participants
All patients
|
|---|---|---|---|---|---|
|
Number of Days of Fever
Cycle 6 - Yes
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Days of Fever
Cycle 1 - No
|
39 participants
|
41 participants
|
42 participants
|
46 participants
|
168 participants
|
|
Number of Days of Fever
Cycle 1 - Yes
|
1 participants
|
4 participants
|
2 participants
|
0 participants
|
7 participants
|
|
Number of Days of Fever
Cycle 2 - No
|
36 participants
|
43 participants
|
44 participants
|
46 participants
|
169 participants
|
|
Number of Days of Fever
Cycle 2 - Yes
|
4 participants
|
2 participants
|
0 participants
|
0 participants
|
6 participants
|
|
Number of Days of Fever
Cycle 3 - No
|
40 participants
|
44 participants
|
44 participants
|
45 participants
|
173 participants
|
|
Number of Days of Fever
Cycle 3 - Yes
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Days of Fever
Cycle 4 - No
|
40 participants
|
44 participants
|
43 participants
|
46 participants
|
173 participants
|
|
Number of Days of Fever
Cycle 4 - Yes
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Days of Fever
Cycle 5 - No
|
40 participants
|
44 participants
|
43 participants
|
45 participants
|
172 participants
|
|
Number of Days of Fever
Cycle 5 - Yes
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Days of Fever
Cycle 6 - No
|
39 participants
|
44 participants
|
44 participants
|
46 participants
|
173 participants
|
SECONDARY outcome
Timeframe: Cycle 1/ 21 daysPopulation: FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation
Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1
Outcome measures
| Measure |
EP2006 + EP2006 & Neupogen
n=107 Participants
All subjects randomized to receive either EP2006 in Cycle 1
|
Neupogen + Neupogen & EP2006
n=107 Participants
All subjects randomized to receive Neupogen in Cycle 1
|
Neupogen + EP2006
n=214 Participants
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
Patients remained on Neupogen (their initial treatment) throughout the study
|
Total
All patients
|
|---|---|---|---|---|---|
|
Depth of Absolute Neutrophil Count Nadir
|
0.808 10^9 cells/L
Standard Deviation 1.3694
|
0.744 10^9 cells/L
Standard Deviation 1.2906
|
0.776 10^9 cells/L
Standard Deviation 1.3278
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1/ 21 daysPopulation: FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation. In the EP2006 + EP2006 \& Neupogen group, one patient's time to Absolute Neutrophil Count recovery could not be measured as the nadir was the last measured timepoint.
Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2\*10\^9 cells/L after the nadir in cycle 1
Outcome measures
| Measure |
EP2006 + EP2006 & Neupogen
n=106 Participants
All subjects randomized to receive either EP2006 in Cycle 1
|
Neupogen + Neupogen & EP2006
n=107 Participants
All subjects randomized to receive Neupogen in Cycle 1
|
Neupogen + EP2006
n=213 Participants
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
Patients remained on Neupogen (their initial treatment) throughout the study
|
Total
All patients
|
|---|---|---|---|---|---|
|
Time to Absolute Neutrophil Count Recovery
|
2.0 Days
Interval 0.0 to 6.0
|
2.0 Days
Interval 0.0 to 4.0
|
2.0 Days
Interval 0.0 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 Weeks/ 6 cyclesPopulation: SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. Comparison made for alternating versus non-alternating treatment groups.
Frequency of infections by cycle and across all cycles
Outcome measures
| Measure |
EP2006 + EP2006 & Neupogen
n=103 Participants
All subjects randomized to receive either EP2006 in Cycle 1
|
Neupogen + Neupogen & EP2006
n=107 Participants
All subjects randomized to receive Neupogen in Cycle 1
|
Neupogen + EP2006
n=210 Participants
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
Patients remained on Neupogen (their initial treatment) throughout the study
|
Total
All patients
|
|---|---|---|---|---|---|
|
Frequency of Infections
All Cycles - Yes
|
7 participants
|
10 participants
|
17 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 1 - No
|
102 participants
|
104 participants
|
206 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 1 - Yes
|
1 participants
|
3 participants
|
4 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 2 - No
|
100 participants
|
102 participants
|
202 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 2 - Yes
|
3 participants
|
5 participants
|
8 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 3 - No
|
102 participants
|
107 participants
|
209 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 3 - Yes
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 4 - No
|
101 participants
|
104 participants
|
205 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 4 - Yes
|
2 participants
|
3 participants
|
5 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 5 - No
|
101 participants
|
106 participants
|
207 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 5 - Yes
|
2 participants
|
1 participants
|
3 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 6 - No
|
102 participants
|
106 participants
|
208 participants
|
—
|
—
|
|
Frequency of Infections
Cycle 6 - Yes
|
1 participants
|
1 participants
|
2 participants
|
—
|
—
|
|
Frequency of Infections
All Cycles - No
|
96 participants
|
97 participants
|
193 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 Weeks/ 6 cyclesPopulation: SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.
Incidence of hospitalizations due to Febrile Neutropenia
Outcome measures
| Measure |
EP2006 + EP2006 & Neupogen
n=52 Participants
All subjects randomized to receive either EP2006 in Cycle 1
|
Neupogen + Neupogen & EP2006
n=52 Participants
All subjects randomized to receive Neupogen in Cycle 1
|
Neupogen + EP2006
n=55 Participants
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
n=51 Participants
Patients remained on Neupogen (their initial treatment) throughout the study
|
Total
n=210 Participants
All patients
|
|---|---|---|---|---|---|
|
Incidence of Hospitalizations Due to Febrile Neutropenia
No
|
50 participants
|
50 participants
|
55 participants
|
51 participants
|
206 participants
|
|
Incidence of Hospitalizations Due to Febrile Neutropenia
Yes
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
4 participants
|
Adverse Events
EP2006
Serious events: 6 serious events
Other events: 50 other events
Deaths: 0 deaths
EP2006 + Neupogen
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Neupogen + EP2006
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Neupogen
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EP2006
n=53 participants at risk
Patients remained on EP2006 (their initial treatment) throughout the study
|
EP2006 + Neupogen
n=54 participants at risk
Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
|
Neupogen + EP2006
n=55 participants at risk
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
n=52 participants at risk
Patients remained on Neupogen (their initial treatment) throughout the study
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.7%
3/53 • Number of events 3
|
7.4%
4/54 • Number of events 4
|
1.8%
1/55 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/53
|
0.00%
0/54
|
0.00%
0/55
|
1.9%
1/52 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/52
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/53
|
0.00%
0/54
|
0.00%
0/55
|
1.9%
1/52 • Number of events 1
|
|
Vascular disorders
Embolism
|
1.9%
1/53 • Number of events 1
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/52
|
|
Vascular disorders
Hypertensive crisis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/52
|
Other adverse events
| Measure |
EP2006
n=53 participants at risk
Patients remained on EP2006 (their initial treatment) throughout the study
|
EP2006 + Neupogen
n=54 participants at risk
Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
|
Neupogen + EP2006
n=55 participants at risk
Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
|
Neupogen
n=52 participants at risk
Patients remained on Neupogen (their initial treatment) throughout the study
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
77.4%
41/53 • Number of events 43
|
81.5%
44/54 • Number of events 45
|
78.2%
43/55 • Number of events 46
|
82.7%
43/52 • Number of events 44
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.4%
5/53 • Number of events 15
|
3.7%
2/54 • Number of events 3
|
10.9%
6/55 • Number of events 19
|
11.5%
6/52 • Number of events 23
|
|
General disorders
Asthenia
|
37.7%
20/53 • Number of events 66
|
51.9%
28/54 • Number of events 98
|
58.2%
32/55 • Number of events 111
|
53.8%
28/52 • Number of events 101
|
|
General disorders
Fatigue
|
32.1%
17/53 • Number of events 52
|
16.7%
9/54 • Number of events 17
|
20.0%
11/55 • Number of events 38
|
25.0%
13/52 • Number of events 38
|
|
General disorders
Hypothermia
|
0.00%
0/53
|
5.6%
3/54 • Number of events 6
|
1.8%
1/55 • Number of events 14
|
1.9%
1/52 • Number of events 1
|
|
General disorders
Pyrexia
|
11.3%
6/53 • Number of events 9
|
5.6%
3/54 • Number of events 8
|
1.8%
1/55 • Number of events 1
|
1.9%
1/52 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
54.7%
29/53 • Number of events 103
|
61.1%
33/54 • Number of events 95
|
58.2%
32/55 • Number of events 116
|
71.2%
37/52 • Number of events 149
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
5/53 • Number of events 8
|
20.4%
11/54 • Number of events 14
|
23.6%
13/55 • Number of events 21
|
15.4%
8/52 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
9/53 • Number of events 27
|
18.5%
10/54 • Number of events 22
|
18.2%
10/55 • Number of events 21
|
17.3%
9/52 • Number of events 19
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
2/53 • Number of events 3
|
0.00%
0/54
|
9.1%
5/55 • Number of events 10
|
3.8%
2/52 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
3/53 • Number of events 8
|
3.7%
2/54 • Number of events 2
|
7.3%
4/55 • Number of events 7
|
5.8%
3/52 • Number of events 6
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
3/53 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
0.00%
0/55
|
3.8%
2/52 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
24.5%
13/53 • Number of events 33
|
37.0%
20/54 • Number of events 46
|
34.5%
19/55 • Number of events 60
|
36.5%
19/52 • Number of events 60
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
3/53 • Number of events 8
|
7.4%
4/54 • Number of events 4
|
10.9%
6/55 • Number of events 8
|
5.8%
3/52 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
2/53 • Number of events 5
|
5.6%
3/54 • Number of events 4
|
5.5%
3/55 • Number of events 5
|
5.8%
3/52 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculosceletal pain
|
9.4%
5/53 • Number of events 6
|
1.9%
1/54 • Number of events 2
|
3.6%
2/55 • Number of events 3
|
1.9%
1/52 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.4%
5/53 • Number of events 21
|
13.0%
7/54 • Number of events 18
|
10.9%
6/55 • Number of events 20
|
11.5%
6/52 • Number of events 22
|
|
Blood and lymphatic system disorders
Anaemia
|
11.3%
6/53 • Number of events 10
|
9.3%
5/54 • Number of events 9
|
7.3%
4/55 • Number of events 6
|
21.2%
11/52 • Number of events 24
|
|
Blood and lymphatic system disorders
Leucopenia
|
7.5%
4/53 • Number of events 21
|
7.4%
4/54 • Number of events 12
|
3.6%
2/55 • Number of events 3
|
5.8%
3/52 • Number of events 9
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.7%
3/53 • Number of events 3
|
9.3%
5/54 • Number of events 5
|
1.8%
1/55 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.7%
3/53 • Number of events 8
|
0.00%
0/54
|
5.5%
3/55 • Number of events 4
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.7%
3/53 • Number of events 6
|
5.6%
3/54 • Number of events 3
|
3.6%
2/55 • Number of events 2
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Periferal sensory neur.
|
5.7%
3/53 • Number of events 3
|
0.00%
0/54
|
3.6%
2/55 • Number of events 2
|
1.9%
1/52 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
15.1%
8/53 • Number of events 21
|
7.4%
4/54 • Number of events 8
|
5.5%
3/55 • Number of events 6
|
25.0%
13/52 • Number of events 32
|
|
Vascular disorders
Flushing
|
1.9%
1/53 • Number of events 3
|
5.6%
3/54 • Number of events 10
|
0.00%
0/55
|
3.8%
2/52 • Number of events 7
|
Additional Information
Dr. Roumen Nakov, Global Programme Medical Director
Sandoz
Phone: +49 8024 4764704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall provide Sponsor with any presentation at least 15 working days prior to disclosure and any other publication at least 45 working days prior to disclosure. Sponsor may require amendments on reasonable grounds: (a) accuracy of publication; (b) confidentiality of proprietary information; (c) intellectual property protection; (d) to enable further information to be provided. Sponsor may require publications or presentations to be delayed up to four (4) months to enable patent application.
- Publication restrictions are in place
Restriction type: OTHER