Trial Outcomes & Findings for OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission (NCT NCT00857545)
NCT ID: NCT00857545
Last Updated: 2017-09-13
Results Overview
Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
171 participants
Primary outcome timeframe
Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.
Results posted on
2017-09-13
Participant Flow
The study was activated on 7/26/2010 and closed to accrual on 2/4/2013.
Participant milestones
| Measure |
Polyvalent Antigen-KLH+OPT-821 Vaccine
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
Non-specific Immunity With OPT-821
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
|
Overall Study
COMPLETED
|
86
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission
Baseline characteristics by cohort
| Measure |
Polyvalent Antigen-KLH+OPT-821 Vaccine
n=86 Participants
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
Non-specific Immunity With OPT-821
n=85 Participants
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Age, Customized
40-49
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Customized
50-59
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Customized
60-69
|
37 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Customized
70-79
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Customized
80-89
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Recurring and/or Persistent Disease
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Cell Type
Adenocarcinoma with Squam. Diff ' n
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cell Type
Adenocarcinoma, Unsp.
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cell Type
Adenosquamous
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cell Type
Clear Cell Carcinoma
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cell Type
Endometrioid Adenocarcinoma
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cell Type
Mixed Epithelial Carcinoma
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cell Type
Other Carcinoma
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cell Type
Serous Adenocarcinoma
|
69 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Cell Type
Transitional Cell Carcinoma
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cell Type
Undifferentiated Carcinoma
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.Population: Enrolled and randomized participants. 95% two-sided confidence interval
Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.
Outcome measures
| Measure |
Polyvalent Antigen-KLH+OPT-821 Vaccine
n=86 Participants
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
Non-specific Immunity With OPT-821
n=85 Participants
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.9 Months
Interval 5.4 to 7.7
|
6.5 Months
Interval 5.1 to 7.9
|
SECONDARY outcome
Timeframe: During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.Population: Enrolled and randomized and treated Patients. Grade 3 or worse adverse events for gastrointestinal disorders were significantly associated with treatment arm at significant level of 0.05 by two-sided Fisher's exact test. The reporting arm 2 had higher proportion of patients with reported grade 3 or worse adverse events.
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Outcome measures
| Measure |
Polyvalent Antigen-KLH+OPT-821 Vaccine
n=86 Participants
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
Non-specific Immunity With OPT-821
n=85 Participants
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
|---|---|---|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Leukopenia
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Thrombocytopenia
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Neutropenia
|
1 participants
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Anemia
|
0 participants
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Other Investigations
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Eye disorders
|
0 participants
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Gastrointestinal Disorders
|
2 participants
|
10 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
General disorders & administration site condition
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Immune system disorders
|
0 participants
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Infections and infestations
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Metabolism and nutrition disorders
|
3 participants
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Neoplasms benign, malignant & unspecified
|
2 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Nervous System
|
1 participants
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Psychiatric disorders
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Renal and urinary disorders
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Vascular disorders
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 years of follow-up.Population: Enrolled and randomized participants. The upper limit of the 95% confidence interval for OS median in arm 1 is not available because the data is not mature enough for estimation at the time of this report.
Overall survival is defined as the duration of time from study entry to time of death due to any cause or the date of last contact.
Outcome measures
| Measure |
Polyvalent Antigen-KLH+OPT-821 Vaccine
n=86 Participants
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
Non-specific Immunity With OPT-821
n=85 Participants
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
|---|---|---|
|
Overall Survival
|
46.5 Months
Interval 36.4 to
As of date of submission, data is not mature enough to evaluate median confidence interval.
|
46.2 Months
Interval 29.6 to 50.5
|
Adverse Events
Polyvalent Antigen-KLH+OPT-821 Vaccine
Serious events: 5 serious events
Other events: 84 other events
Deaths: 0 deaths
Non-specific Immunity With OPT-821
Serious events: 14 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Polyvalent Antigen-KLH+OPT-821 Vaccine
n=86 participants at risk
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
Non-specific Immunity With OPT-821
n=84 participants at risk
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
|---|---|---|
|
Gastrointestinal disorders
Colonic Obstruction
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.0%
5/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Ileal Obstruction
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fever
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Autoimmune Disorder
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl cysts and polyps)
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Personality Change
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Other adverse events
| Measure |
Polyvalent Antigen-KLH+OPT-821 Vaccine
n=86 participants at risk
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
Non-specific Immunity With OPT-821
n=84 participants at risk
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Anemia
|
36.0%
31/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
39.3%
33/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Palpitations
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Vertigo
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Endocrine disorders
Hypothyroidism
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Eye Disorders - Other
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Watering Eyes
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Scleral Disorder
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Cataract
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Blurred Vision
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Constipation
|
17.4%
15/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
19.0%
16/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
7.0%
6/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.0%
5/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
5/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
11.9%
10/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Bloating
|
7.0%
6/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Stomach Pain
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
19.8%
17/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
22.6%
19/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Pancreatic Necrosis
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis Oral
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Nausea
|
15.1%
13/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
19.0%
16/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastroparesis
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Lip Pain
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Esophageal Pain
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
General Disorders And Administration Site Conditio
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain
|
10.5%
9/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.0%
5/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Malaise
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Irritability
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Injection Site Reaction
|
83.7%
72/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
81.0%
68/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Flu Like Symptoms
|
11.6%
10/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
10.7%
9/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Edema Limbs
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fatigue
|
48.8%
42/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
41.7%
35/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fever
|
19.8%
17/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Chills
|
5.8%
5/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Infusion Related Reaction
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Allergic Reaction
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Autoimmune Disorder
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Immune System Disorders - Other
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Upper Respiratory Infection
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Skin Infection
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Sinusitis
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Rhinitis Infective
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Papulopustular Rash
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Mucosal Infection
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Urinary Tract Infection
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
7.1%
6/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Enterocolitis Infectious
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications - O
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Injury, poisoning and procedural complications
Radiation Recall Reaction (Dermatologic)
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Investigations - Other
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Weight Loss
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Weight Gain
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Platelet Count Decreased
|
15.1%
13/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
20.2%
17/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Lymphocyte Count Increased
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Lymphocyte Count Decreased
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
4/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Creatinine Increased
|
5.8%
5/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
8.3%
7/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Cholesterol High
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Neutrophil Count Decreased
|
18.6%
16/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
20.2%
17/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
White Blood Cell Decreased
|
20.9%
18/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
25.0%
21/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.8%
5/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
7.1%
6/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Alkaline Phosphatase Increased
|
8.1%
7/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
14.3%
12/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.8%
5/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
7.1%
6/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.1%
7/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
4/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.0%
5/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.8%
11/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
20.2%
17/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.0%
5/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.0%
6/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
4/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.8%
11/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
11.9%
10/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.1%
13/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
13.1%
11/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.0%
5/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
7/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
11.9%
10/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder -
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Nervous System Disorders - Other
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
16.3%
14/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
22.6%
19/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
4/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Memory Impairment
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Headache
|
10.5%
9/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
15.5%
13/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Sinus Pain
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Syncope
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Dizziness
|
9.3%
8/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
4/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Cognitive Disturbance
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Ataxia
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Suicidal Ideation
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Insomnia
|
5.8%
5/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.0%
5/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Depression
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Anxiety
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
6.0%
5/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Frequency
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
10.7%
9/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Hematuria
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
5.8%
5/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
4.8%
4/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Breast Pain
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
8.3%
7/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
5/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
7.1%
6/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
6/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
8.1%
7/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
10.7%
9/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
4.7%
4/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.5%
3/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hypotension
|
1.2%
1/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
1.2%
1/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hypertension
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hot Flashes
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
3.6%
3/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hematoma
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
0.00%
0/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Flushing
|
2.3%
2/86 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
2.4%
2/84 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place