Trial Outcomes & Findings for Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer (NCT NCT03511378)
NCT ID: NCT03511378
Last Updated: 2021-06-15
Results Overview
The difference in cumulative incidence of anti-pegfilgrastim antibodies (binding and neutralizing) (measured as difference in proportion of patients with antibodies) to Pegfilgrastim between study groups at the end of cycle 4 will be calculated. Those samples confirmed to be positive for binding antibodies were analyzed for presence of neutralizing antibodies to Pegfilgrastim.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
138 participants
Primary outcome timeframe
End of cycle 4, Day 84
Results posted on
2021-06-15
Participant Flow
The treatment group (Lupin pegfilgrastim or Neulasta®) for each patient during the study was determined according to the study randomization list. The treatment was assigned at the time of randomization, after confirming the patient's eligibility. Patients were randomized in a 1:1 ratio to receive either Lupin pegfilgrastim or Neulasta®.
All enrolled population included all screened patients who signed the informed consent. The randomized population included all randomized patients irrespective of whether patient received any study drug.
Participant milestones
| Measure |
Lupin's Pegfilgrastim
6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
68
|
|
Overall Study
COMPLETED
|
67
|
66
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Lupin's Pegfilgrastim
6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Patient not coming or schedule visit
|
1
|
0
|
Baseline Characteristics
Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Lupin's Pegfilgrastim
n=70 Participants
6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
n=68 Participants
6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 11.59 • n=99 Participants
|
48.8 years
STANDARD_DEVIATION 8.73 • n=107 Participants
|
51.2 years
STANDARD_DEVIATION 10.52 • n=206 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
70 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
India
|
70 participants
n=99 Participants
|
68 participants
n=107 Participants
|
138 participants
n=206 Participants
|
|
ECOG Status at Screening
Grade 0
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
ECOG Status at Screening
Grade 1
|
50 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
ECOG Status at Screening
Grade 2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
ECOG Status at Screening
Grade 3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
ECOG Status at Screening
Grade 4
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
ECOG Status at Screening
Grade 5
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: End of cycle 4, Day 84Population: Intention-to-treat analysis population
The difference in cumulative incidence of anti-pegfilgrastim antibodies (binding and neutralizing) (measured as difference in proportion of patients with antibodies) to Pegfilgrastim between study groups at the end of cycle 4 will be calculated. Those samples confirmed to be positive for binding antibodies were analyzed for presence of neutralizing antibodies to Pegfilgrastim.
Outcome measures
| Measure |
Lupin's Pegfilgrastim
n=69 Participants
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
n=68 Participants
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
|---|---|---|
|
Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).
|
0.0145 Proportion of patients with antibodies
|
0.0441 Proportion of patients with antibodies
|
SECONDARY outcome
Timeframe: Day 84.Population: Intention to treat population
The presence of anti-peg antibodies (binding) (measured as difference in proportion of patients with antibodies) between treatment groups at the end of cycle 4 (Day 84) were compared and analysis for the ITT population
Outcome measures
| Measure |
Lupin's Pegfilgrastim
n=69 Participants
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
n=68 Participants
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
|---|---|---|
|
Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84).
|
0.0145 Proportion of patients with antibodies
|
0 Proportion of patients with antibodies
|
SECONDARY outcome
Timeframe: Assessment at each study visit on Day 10, Day 21, Day 42, Day 63, Day 84Population: The Intention-to-Treat (ITT) population included all patients who received at least one dose of study medication and subsequently provided immunogenicity variable data.
Comparison of incidence of anti-pegfilgrastim antibodies (binding \& neutralizing) (measured as difference in proportion of patients with antibodies) to pegfilgrastim between treatment groups on Day 10, Day 21, Day 42, Day 63, Day 84. Analysis population : ITT
Outcome measures
| Measure |
Lupin's Pegfilgrastim
n=69 Participants
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
n=68 Participants
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
|---|---|---|
|
Comparison of Incidence of Anti-pegfilgrastim Antibodies (Binding & Neutralizing) to Pegfilgrastim Between Treatment Groups on Day 10, Day 21, Day 42, Day 63 and Day 84
Day 10
|
1 Participants
|
0 Participants
|
|
Comparison of Incidence of Anti-pegfilgrastim Antibodies (Binding & Neutralizing) to Pegfilgrastim Between Treatment Groups on Day 10, Day 21, Day 42, Day 63 and Day 84
Day 21
|
0 Participants
|
1 Participants
|
|
Comparison of Incidence of Anti-pegfilgrastim Antibodies (Binding & Neutralizing) to Pegfilgrastim Between Treatment Groups on Day 10, Day 21, Day 42, Day 63 and Day 84
Day 42
|
1 Participants
|
1 Participants
|
|
Comparison of Incidence of Anti-pegfilgrastim Antibodies (Binding & Neutralizing) to Pegfilgrastim Between Treatment Groups on Day 10, Day 21, Day 42, Day 63 and Day 84
Day 63
|
0 Participants
|
1 Participants
|
|
Comparison of Incidence of Anti-pegfilgrastim Antibodies (Binding & Neutralizing) to Pegfilgrastim Between Treatment Groups on Day 10, Day 21, Day 42, Day 63 and Day 84
Day 84 (EOS)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 10, Day 21, Day 42, Day 63 and Day 84.Population: The Intention-to-Treat (ITT) population included all patients who received at least one dose of study medication and subsequently provided immunogenicity variable data.
Comparison of incidence of anti-peg antibodies (binding \& neutralizing) (measured as difference in proportion of patients with antibodies) between treatment groups on Day 10, Day 21, Day 42, Day 63 and Day 84. Analysis population: ITT population
Outcome measures
| Measure |
Lupin's Pegfilgrastim
n=69 Participants
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
n=68 Participants
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
|---|---|---|
|
Secondary Immunogenicity Endpoint
Day 10
|
0 Participants
|
0 Participants
|
|
Secondary Immunogenicity Endpoint
Day 21
|
0 Participants
|
0 Participants
|
|
Secondary Immunogenicity Endpoint
Day 42
|
1 Participants
|
0 Participants
|
|
Secondary Immunogenicity Endpoint
Day 63
|
0 Participants
|
0 Participants
|
|
Secondary Immunogenicity Endpoint
Day 84 (EOS)
|
0 Participants
|
0 Participants
|
Adverse Events
Lupin's Pegfilgrastim
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Neulasta®
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lupin's Pegfilgrastim
n=70 participants at risk
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
n=68 participants at risk
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/70 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
2.9%
2/68 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/70 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
1.5%
1/68 • Number of events 1 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
Other adverse events
| Measure |
Lupin's Pegfilgrastim
n=70 participants at risk
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Lupin's Pegfilgrastim: Administration of Pegfilgrastim
|
Neulasta®
n=68 participants at risk
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®: Administration of Neulasta®
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
27.1%
19/70 • Number of events 24 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
29.4%
20/68 • Number of events 27 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
14/70 • Number of events 16 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
26.5%
18/68 • Number of events 24 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
7/70 • Number of events 9 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
7.4%
5/68 • Number of events 10 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
3/70 • Number of events 4 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
4.4%
3/68 • Number of events 3 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
2/70 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
1.5%
1/68 • Number of events 1 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
2/70 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
0.00%
0/68 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.6%
27/70 • Number of events 28 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
32.4%
22/68 • Number of events 22 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
General disorders
Asthenia
|
18.6%
13/70 • Number of events 17 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
22.1%
15/68 • Number of events 23 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
General disorders
Pain
|
8.6%
6/70 • Number of events 7 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
11.8%
8/68 • Number of events 10 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
General disorders
Pyrexia
|
4.3%
3/70 • Number of events 4 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
4.4%
3/68 • Number of events 4 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
General disorders
Mucosal inflammation
|
4.3%
3/70 • Number of events 3 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
1.5%
1/68 • Number of events 1 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.6%
6/70 • Number of events 6 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
8.8%
6/68 • Number of events 8 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
5/70 • Number of events 6 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
8.8%
6/68 • Number of events 8 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.4%
1/70 • Number of events 1 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
4.4%
3/68 • Number of events 3 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/70 • Number of events 1 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
2.9%
2/68 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Nervous system disorders
Headache
|
7.1%
5/70 • Number of events 5 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
13.2%
9/68 • Number of events 9 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/70 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
2.9%
2/68 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
6/70 • Number of events 6 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
8.8%
6/68 • Number of events 6 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.4%
1/70 • Number of events 1 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
2.9%
2/68 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
2/70 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
4.4%
3/68 • Number of events 3 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Infections and infestations
Pyuria
|
2.9%
2/70 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
1.5%
1/68 • Number of events 1 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/70 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
4.4%
3/68 • Number of events 4 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Infections and infestations
Bacterial infection
|
2.9%
2/70 • Number of events 3 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
0.00%
0/68 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
2/70 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
5.9%
4/68 • Number of events 5 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/70 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
2.9%
2/68 • Number of events 2 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.7%
4/70 • Number of events 4 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
1.5%
1/68 • Number of events 1 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/70 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
2.9%
2/68 • Number of events 3 • 3 months
Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.
|
Additional Information
Dr. Chirag Shah, Director
Lupin Ltd. (Lupin Research Park), Pune, India
Phone: 91-20-67917368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place