Trial Outcomes & Findings for Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3 (NCT NCT03102606)
NCT ID: NCT03102606
Last Updated: 2024-08-29
Results Overview
Duration of severe neutropenia (ANC \< 0.5 × 109/L)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
105 participants
Primary outcome timeframe
21 Days
Results posted on
2024-08-29
Participant Flow
Participant milestones
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
COMPLETED
|
39
|
45
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3
Baseline characteristics by cohort
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 10.85 • n=99 Participants
|
57.0 years
STANDARD_DEVIATION 10.79 • n=107 Participants
|
58.0 years
STANDARD_DEVIATION 10.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
40 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
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 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
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 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
|
PRIMARY outcome
Timeframe: 21 DaysDuration of severe neutropenia (ANC \< 0.5 × 109/L)
Outcome measures
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Duration of Severe Neutropenia (DSN)
|
0.246 Days
Interval 0.205 to 0.287
|
0.770 Days
Interval 0.682 to 0.857
|
SECONDARY outcome
Timeframe: Day 1 through 8 in Cycle 1 (each cycle is 21 days)Change in estimated mean bone pain score from pre-dose Day 1 through Day 8. The bone pain scale assessment was based on the validated Wong-Baker Faces® Pain Rating Scale. The pain scale range is from 0 to 10. The severity of pain marked on a scale is from 0 ('no hurt') to 10 ('hurt worst').
Outcome measures
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Change in Estimated Mean Bone Pain Score
|
2.35 Wong-Baker FACES Pain Scale (range:0-10)
Standard Error 0.178
|
1.69 Wong-Baker FACES Pain Scale (range:0-10)
Standard Error 0.179
|
SECONDARY outcome
Timeframe: Anytime during Cycle 1 (each cycle is 21 days)Patients with platelet count at least 30% change from baseline at any time during Cycle 1
Outcome measures
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Change in Patients With at Least 30% Platelet Count From Baseline in Cycle 1
|
41 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 15 DaysProportion of patients with neutrophil-to-lymphocyte ratio (NLR) \> 5 from Day 1 through Day 15
Outcome measures
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Proportion of Patients With Neutrophil-to-lymphocyte Ratio (NLR) > 5
|
24 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 84 daysProportion of patients with thrombocytopenia (all grade) during 4 cycles
Outcome measures
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Proportion of Patients With Thrombocytopenia
|
19 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 84 DaysIncidence of infections in cycles 1 to 4
Outcome measures
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Infections
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 21 DaysIncidence of antibiotic use
Outcome measures
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Antibiotic Use
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 84 DaysTo assess the incidence of sepsis
Outcome measures
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 Participants
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 Participants
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Sepsis
|
0 Participants
|
0 Participants
|
Adverse Events
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
Serious events: 6 serious events
Other events: 49 other events
Deaths: 1 deaths
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
Serious events: 8 serious events
Other events: 51 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 participants at risk
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 participants at risk
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.9%
1/53 • Number of events 2 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/53 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/53 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Liver injury
|
1.9%
1/53 • Number of events 2 • 6 months
|
0.00%
0/52 • 6 months
|
|
Infections and infestations
Lung infection
|
100.0%
2/2 • Number of events 2 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/53 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/53 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/53 • 6 months
|
1.9%
1/52 • Number of events 2 • 6 months
|
|
Nervous system disorders
Syncope
|
1.9%
1/53 • Number of events 1 • 6 months
|
0.00%
0/52 • 6 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/53 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.9%
1/53 • Number of events 1 • 6 months
|
0.00%
0/52 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/53 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/53 • 6 months
|
1.9%
1/52 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin
n=53 participants at risk
Arm 1
Pegfilgrastim: PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
D5W Placebo: Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|
Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim
n=52 participants at risk
Arm 2
Plinabulin: Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
Saline Placebo: Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
24.5%
13/53 • 6 months
|
32.7%
17/52 • 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.2%
7/53 • 6 months
|
23.1%
12/52 • 6 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.2%
7/53 • 6 months
|
19.2%
10/52 • 6 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/53 • 6 months
|
7.7%
4/52 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
9.4%
5/53 • 6 months
|
21.2%
11/52 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
15.1%
8/53 • 6 months
|
15.4%
8/52 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
7.5%
4/53 • 6 months
|
7.7%
4/52 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/53 • 6 months
|
7.7%
4/52 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/53 • 6 months
|
9.6%
5/52 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
2/53 • 6 months
|
5.8%
3/52 • 6 months
|
|
General disorders
Asthenia
|
18.9%
10/53 • 6 months
|
13.5%
7/52 • 6 months
|
|
General disorders
Malaise
|
9.4%
5/53 • 6 months
|
17.3%
9/52 • 6 months
|
|
General disorders
Fatigue
|
3.8%
2/53 • 6 months
|
11.5%
6/52 • 6 months
|
|
General disorders
Pyrexia
|
3.8%
2/53 • 6 months
|
5.8%
3/52 • 6 months
|
|
Gastrointestinal disorders
Face oedema
|
1.9%
1/53 • 6 months
|
5.8%
3/52 • 6 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/53 • 6 months
|
7.7%
4/52 • 6 months
|
|
Investigations
Neutrophil count decreased
|
18.9%
10/53 • 6 months
|
44.2%
23/52 • 6 months
|
|
Investigations
White blood cell count decreased
|
18.9%
10/53 • 6 months
|
40.4%
21/52 • 6 months
|
|
Injury, poisoning and procedural complications
Alanine aminotransferase increased
|
15.1%
8/53 • 6 months
|
13.5%
7/52 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
15.1%
8/53 • 6 months
|
13.5%
7/52 • 6 months
|
|
Investigations
Platelet count decreased
|
11.3%
6/53 • 6 months
|
7.7%
4/52 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.5%
13/53 • 6 months
|
15.4%
8/52 • 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.4%
5/53 • 6 months
|
19.2%
10/52 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/53 • 6 months
|
5.8%
3/52 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
28.3%
15/53 • 6 months
|
34.6%
18/52 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/53 • 6 months
|
11.5%
6/52 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/53 • 6 months
|
5.8%
3/52 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • 6 months
|
5.8%
3/52 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
1/53 • 6 months
|
5.8%
3/52 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/53 • 6 months
|
5.8%
3/52 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
32.1%
17/53 • 6 months
|
32.7%
17/52 • 6 months
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • 6 months
|
13.5%
7/52 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place