Trial Outcomes & Findings for Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel (NCT NCT01126190)
NCT ID: NCT01126190
Last Updated: 2023-03-28
Results Overview
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<0.5 x 10\^9/liter \[L\]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
381 participants
Primary outcome timeframe
Cycle 1 (cycle length = 21 days)
Results posted on
2023-03-28
Participant Flow
Participant milestones
| Measure |
Double-Blind Phase: Pegfilgrastim
Participants received pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Open-Label Phase: Neugranin 40 mg
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
|---|---|---|---|
|
Double-Blind Phase
STARTED
|
151
|
153
|
0
|
|
Double-Blind Phase
Received at Least 1 Dose of Study Drug
|
150
|
153
|
0
|
|
Double-Blind Phase
Completed Without a Major Protocol Deviation
|
148
|
150
|
77
|
|
Double-Blind Phase
COMPLETED
|
145
|
138
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
6
|
15
|
0
|
|
Open-Label Phase
STARTED
|
0
|
0
|
77
|
|
Open-Label Phase
Received at Least 1 Dose of Study Drug
|
0
|
0
|
77
|
|
Open-Label Phase
COMPLETED
|
0
|
0
|
66
|
|
Open-Label Phase
NOT COMPLETED
|
0
|
0
|
11
|
Reasons for withdrawal
| Measure |
Double-Blind Phase: Pegfilgrastim
Participants received pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Open-Label Phase: Neugranin 40 mg
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
|---|---|---|---|
|
Double-Blind Phase
Death
|
0
|
1
|
0
|
|
Double-Blind Phase
Adverse Event
|
1
|
2
|
0
|
|
Double-Blind Phase
Withdrawal by Subject
|
2
|
5
|
0
|
|
Double-Blind Phase
Request of Investigator
|
1
|
0
|
0
|
|
Double-Blind Phase
Treatment Failure/Disease Progression
|
0
|
4
|
0
|
|
Double-Blind Phase
Non-compliance
|
1
|
0
|
0
|
|
Double-Blind Phase
Lost to Follow-up
|
1
|
3
|
0
|
|
Open-Label Phase
Death
|
0
|
0
|
1
|
|
Open-Label Phase
Adverse Event
|
0
|
0
|
4
|
|
Open-Label Phase
Withdrawal by Subject
|
0
|
0
|
6
|
Baseline Characteristics
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Baseline characteristics by cohort
| Measure |
Double-Blind Phase: Pegfilgrastim
n=151 Participants
Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
n=153 Participants
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Open-Label Phase: Neugranin 40 mg
n=77 Participants
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 10.28 • n=7 Participants
|
52.2 years
STANDARD_DEVIATION 10.22 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
381 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
151 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
381 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (cycle length = 21 days)Population: Per protocol (PP) population included all data from randomized participants that were obtained prior to experiencing major protocol violations.
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<0.5 x 10\^9/liter \[L\]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle.
Outcome measures
| Measure |
Double-Blind Phase: Pegfilgrastim
n=148 Participants
Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
n=150 Participants
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
|---|---|---|
|
Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1
|
1.0 days
Standard Deviation 1.08
|
1.1 days
Standard Deviation 1.13
|
PRIMARY outcome
Timeframe: Cycle 1 (cycle length = 21 days)Population: PP population included all data from randomized participants that were obtained prior to experiencing major protocol violations.
Severe neutropenia was defined as Grade 4 neutropenia (ANC \<0.5 x 10\^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.
Outcome measures
| Measure |
Double-Blind Phase: Pegfilgrastim
n=77 Participants
Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
|---|---|---|
|
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
|
1.0 days
Standard Deviation 1.03
|
—
|
SECONDARY outcome
Timeframe: Cycles 1-4 (each cycle = 21 days)Population: PP population included all data from randomized participants that were obtained prior to experiencing major protocol violations.
Febrile neutropenia was defined as an imputed or observed ANC \<0.5 x 10\^9/L and body temperature \>38.5 degrees celsius (°C) occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Outcome measures
| Measure |
Double-Blind Phase: Pegfilgrastim
n=148 Participants
Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
n=150 Participants
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
|---|---|---|
|
Double-Blind Phase: Number of Participants With Febrile Neutropenia
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Cycles 1-4 (each cycle = 21 days)Population: PP population included all data from randomized participants that were obtained prior to experiencing major protocol violations.
Febrile neutropenia was defined as an imputed or observed ANC \<0.5 x 10\^9/L and body temperature \>38.5 °C occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Outcome measures
| Measure |
Double-Blind Phase: Pegfilgrastim
n=77 Participants
Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
|---|---|---|
|
Open-Label Phase: Number of Participants With Febrile Neutropenia
|
2 participants
|
—
|
Adverse Events
Double-Blind Phase: Pegfilgrastim
Serious events: 7 serious events
Other events: 134 other events
Deaths: 0 deaths
Double-Blind Phase: Neugranin 40 mg
Serious events: 6 serious events
Other events: 139 other events
Deaths: 2 deaths
Open-Label Phase: Neugranin 40 mg
Serious events: 6 serious events
Other events: 71 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Double-Blind Phase: Pegfilgrastim
n=150 participants at risk
Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
n=153 participants at risk
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Open-Label Phase: Neugranin 40 mg
n=77 participants at risk
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
1.3%
2/150 • Number of events 2 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.65%
1/153 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
4/150 • Number of events 4 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
2/153 • Number of events 2 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
2.6%
2/77 • Number of events 2 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
2/153 • Number of events 2 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
2.6%
2/77 • Number of events 2 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
General disorders
Disease progression
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
General disorders
Multi-organ failure
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.65%
1/153 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
General disorders
Vascular complication associated with device
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.65%
1/153 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.65%
1/153 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.65%
1/153 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Infections and infestations
Device related infection
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.65%
1/153 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.67%
1/150 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.65%
1/153 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Vascular disorders
Hypotension
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Vascular disorders
Shock
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/150 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
1.3%
1/77 • Number of events 1 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
Other adverse events
| Measure |
Double-Blind Phase: Pegfilgrastim
n=150 participants at risk
Participants received pegfilgrastim 6 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Double-Blind Phase: Neugranin 40 mg
n=153 participants at risk
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
Open-Label Phase: Neugranin 40 mg
n=77 participants at risk
Participants received neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consisted of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
10/150 • Number of events 34 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
7.8%
12/153 • Number of events 68 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
6.5%
5/77 • Number of events 6 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.7%
22/150 • Number of events 73 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
17.0%
26/153 • Number of events 92 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
24.7%
19/77 • Number of events 63 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.7%
40/150 • Number of events 176 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
29.4%
45/153 • Number of events 164 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
20.8%
16/77 • Number of events 46 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
10/150 • Number of events 33 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
13.7%
21/153 • Number of events 60 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
2.6%
2/77 • Number of events 4 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Ear and labyrinth disorders
Vertigo
|
4.7%
7/150 • Number of events 11 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
3.9%
6/153 • Number of events 8 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
5.2%
4/77 • Number of events 4 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
17/150 • Number of events 24 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
14.4%
22/153 • Number of events 34 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
10.4%
8/77 • Number of events 9 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Gastrointestinal disorders
Nausea
|
41.3%
62/150 • Number of events 146 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
36.6%
56/153 • Number of events 144 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
33.8%
26/77 • Number of events 56 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Gastrointestinal disorders
Stomatitis
|
6.0%
9/150 • Number of events 12 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
7.2%
11/153 • Number of events 15 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
3.9%
3/77 • Number of events 7 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
15/150 • Number of events 18 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
10.5%
16/153 • Number of events 26 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
6.5%
5/77 • Number of events 5 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
General disorders
Asthenia
|
22.0%
33/150 • Number of events 79 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
27.5%
42/153 • Number of events 107 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
28.6%
22/77 • Number of events 48 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
General disorders
Fatigue
|
10.0%
15/150 • Number of events 31 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
10.5%
16/153 • Number of events 35 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
7.8%
6/77 • Number of events 10 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
20/150 • Number of events 46 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
15.7%
24/153 • Number of events 54 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
13.0%
10/77 • Number of events 16 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.7%
16/150 • Number of events 26 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
11.8%
18/153 • Number of events 29 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
18.2%
14/77 • Number of events 39 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
4/150 • Number of events 5 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
6.5%
10/153 • Number of events 17 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
9.1%
7/77 • Number of events 10 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Nervous system disorders
Headache
|
10.7%
16/150 • Number of events 23 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
13.1%
20/153 • Number of events 33 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
9.1%
7/77 • Number of events 10 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
76.0%
114/150 • Number of events 135 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
81.0%
124/153 • Number of events 153 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
77.9%
60/77 • Number of events 76 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
12/150 • Number of events 28 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
7.8%
12/153 • Number of events 28 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
0.00%
0/77 • From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days)
For the double-blind period, the safety population included all randomized participants who received at least 1 dose of randomized study drug. For the open-label period, the safety population included all participants who received at least 1 dose of neugranin.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER