Trial Outcomes & Findings for Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma (NCT NCT03057795)
NCT ID: NCT03057795
Last Updated: 2025-05-07
Results Overview
Progression-free survival will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. When there is no censoring in progression-free survival prior to 18 months after the first dose of study treatment, the observed 18-month progression-free survival will be compared to the baseline of 65% by one-sided exact test of binomial proportion. In case of censoring in progression-free survival prior to 18 months after the first dose of study treatment, the Kaplan-Meier estimate for 18-month progression-free survival along with the Greenwood standard error estimator will be used for the testing of null hypothesis at 65%. Hodgkin Lymphoma(HL) response/progression was evaluated using 2014 Lugano Classification \[Cheson, Journal of Clinical Oncology 2014 Sep 20;32(27):3059-68\].
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 18 months.
Results posted on
2025-05-07
Participant Flow
Three subjects consented but did not participate in the study. Two subjects withdrew consent and one subject became ineligible due to developmental of interstitial pneumonia after consent before screening.
Participant milestones
| Measure |
Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days
Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days
n=59 Participants
Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV Nivolumab: Given IV
|
|---|---|
|
Age, Continuous
|
30 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 18 months.Progression-free survival will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. When there is no censoring in progression-free survival prior to 18 months after the first dose of study treatment, the observed 18-month progression-free survival will be compared to the baseline of 65% by one-sided exact test of binomial proportion. In case of censoring in progression-free survival prior to 18 months after the first dose of study treatment, the Kaplan-Meier estimate for 18-month progression-free survival along with the Greenwood standard error estimator will be used for the testing of null hypothesis at 65%. Hodgkin Lymphoma(HL) response/progression was evaluated using 2014 Lugano Classification \[Cheson, Journal of Clinical Oncology 2014 Sep 20;32(27):3059-68\].
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days
n=59 Participants
Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV Nivolumab: Given IV
|
|---|---|
|
Progression-free Survival at 18 Months
|
94 percentage of survival probability
Interval 84.0 to 98.0
|
SECONDARY outcome
Timeframe: From the first dose of study treatment to death from any cause, assessed up to 18 monthsOverall survival will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days
n=59 Participants
Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV Nivolumab: Given IV
|
|---|---|
|
Overall Survival at 18 Months
|
98 percentage of survival probability
Interval 88.0 to 100.0
|
Adverse Events
Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days
Serious events: 19 serious events
Other events: 59 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days
n=59 participants at risk
Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV Nivolumab: Given IV
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
General disorders
Fever
|
13.6%
8/59 • Number of events 9 • From the date of the first dose up to 48 months.
|
|
Immune system disorders
Cytokine release syndrome
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
Lung Infection
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
Eggerthella lenta pneumonia
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
Lipase increased
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
Neutrophil count decreased
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
Platelet count decreased
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Neuroendocrine Tumor
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.8%
4/59 • Number of events 5 • From the date of the first dose up to 48 months.
|
Other adverse events
| Measure |
Brentuximab Vedotin 1.8 mg/kg + Nivolumab 3 mg/kg Q21 Days
n=59 participants at risk
Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV Nivolumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
18.6%
11/59 • Number of events 25 • From the date of the first dose up to 48 months.
|
|
Cardiac disorders
ASYMPTOMATIC CT SCAN CHANGES
|
1.7%
1/59 • Number of events 6 • From the date of the first dose up to 48 months.
|
|
Cardiac disorders
PALPITATIONS
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
10.2%
6/59 • Number of events 9 • From the date of the first dose up to 48 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
35.6%
21/59 • Number of events 33 • From the date of the first dose up to 48 months.
|
|
Ear and labyrinth disorders
MILD IMBALANCE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
8.5%
5/59 • Number of events 11 • From the date of the first dose up to 48 months.
|
|
Endocrine disorders
INCREASED TSH
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Eye disorders
BLURRED VISION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Eye disorders
EYE PAIN
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Eye disorders
SCLERAL DISORDER
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
18.6%
11/59 • Number of events 19 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
BLOATING
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
COLITIS
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.2%
6/59 • Number of events 9 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
30.5%
18/59 • Number of events 26 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
DIVERTICULITIS
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.8%
4/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.2%
6/59 • Number of events 6 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
5.1%
3/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
ILEUS
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
3.4%
2/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
NAUSEA
|
32.2%
19/59 • Number of events 23 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
ORAL PAIN
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
ORAL THRUSH
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Gastrointestinal disorders
VOMITING
|
22.0%
13/59 • Number of events 14 • From the date of the first dose up to 48 months.
|
|
General disorders
CHILLS
|
25.4%
15/59 • Number of events 19 • From the date of the first dose up to 48 months.
|
|
General disorders
EDEMA LIMBS
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
General disorders
FATIGUE
|
45.8%
27/59 • Number of events 40 • From the date of the first dose up to 48 months.
|
|
General disorders
FEVER
|
23.7%
14/59 • Number of events 18 • From the date of the first dose up to 48 months.
|
|
General disorders
FLU LIKE SYMPTOMS
|
8.5%
5/59 • Number of events 6 • From the date of the first dose up to 48 months.
|
|
General disorders
IMBALANCE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
General disorders
INFUSION RELATED REACTION
|
6.8%
4/59 • Number of events 6 • From the date of the first dose up to 48 months.
|
|
General disorders
INJECTION SITE REACTION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
General disorders
MALAISE
|
6.8%
4/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
General disorders
NONCARDIAC CHEST PAIN
|
6.8%
4/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
General disorders
PAIN
|
10.2%
6/59 • Number of events 7 • From the date of the first dose up to 48 months.
|
|
Hepatobiliary disorders
VOD (IMMUNE RELATED)
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Immune system disorders
ALLERGIC REACTION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
CDIFF
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
HEPATITIS VIRAL
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
LARYNGITIS
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
LUNG INFECTION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
MYCOBACTERIUM AVIUM INTRACELLULARE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
PHARYNGITIS
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
RHINITIS INFECTIVE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
RHINOVIRUS UPPER RESPIRATORY
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
SKIN INFECTION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
42.4%
25/59 • Number of events 39 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
VAGINAL INFECTION
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Infections and infestations
VIRAL INFECTION
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Injury, poisoning and procedural complications
BRUISING
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Injury, poisoning and procedural complications
DOG BITE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Injury, poisoning and procedural complications
FALL
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
1.7%
1/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
23.7%
14/59 • Number of events 22 • From the date of the first dose up to 48 months.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
3.4%
2/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Investigations
AMYLASE DECREASED
|
1.7%
1/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Investigations
APPETITE
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
27.1%
16/59 • Number of events 22 • From the date of the first dose up to 48 months.
|
|
Investigations
BASOPHILS COUNT INCREASED
|
1.7%
1/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Investigations
BLAST COUNT INCREASED
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
8.5%
5/59 • Number of events 7 • From the date of the first dose up to 48 months.
|
|
Investigations
BUN INCREASED
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
CARBON DIOXIDE ELEVATED
|
1.7%
1/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Investigations
CARDIAC TROPONIN I INCREASED
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
CHLORIDE INCREASED
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Investigations
CHOLESTEROL HIGH
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Investigations
CREATININE INCREASED
|
6.8%
4/59 • Number of events 7 • From the date of the first dose up to 48 months.
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
EOSINOPHILS COUNT INCREASED
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Investigations
ERYTHROCYTE SEDRATE ELEVATED
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
FORCED EXPIRATORY VOLUME DECREASED
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
HYPERLIPIDEMIA
|
1.7%
1/59 • Number of events 8 • From the date of the first dose up to 48 months.
|
|
Investigations
INCREASE IN STOOL FREQUENCY
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
LACTOSE DEHYDROGENASE INCREASED
|
11.9%
7/59 • Number of events 14 • From the date of the first dose up to 48 months.
|
|
Investigations
LIPASE INCREASED
|
5.1%
3/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
23.7%
14/59 • Number of events 44 • From the date of the first dose up to 48 months.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
42.4%
25/59 • Number of events 49 • From the date of the first dose up to 48 months.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
13.6%
8/59 • Number of events 14 • From the date of the first dose up to 48 months.
|
|
Investigations
SATIETY
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Investigations
SERUM AMYLASE INCREASED
|
3.4%
2/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Investigations
SKIN NODULE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Investigations
URIC ACID DECREASED
|
3.4%
2/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Investigations
WEIGHT GAIN
|
10.2%
6/59 • Number of events 8 • From the date of the first dose up to 48 months.
|
|
Investigations
WEIGHT LOSS
|
22.0%
13/59 • Number of events 26 • From the date of the first dose up to 48 months.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
27.1%
16/59 • Number of events 36 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
10.2%
6/59 • Number of events 6 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
5.1%
3/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
6.8%
4/59 • Number of events 9 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
6.8%
4/59 • Number of events 6 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
5.1%
3/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
5.1%
3/59 • Number of events 5 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
6.8%
4/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Metabolism and nutrition disorders
OBESITY
|
6.8%
4/59 • Number of events 5 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
25.4%
15/59 • Number of events 19 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.9%
7/59 • Number of events 7 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
6.8%
4/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
5.1%
3/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
22.0%
13/59 • Number of events 20 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.1%
3/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
DIZZINESS
|
5.1%
3/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
DYSESTHESIA
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
DYSGEUSIA
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
HEADACHE
|
18.6%
11/59 • Number of events 14 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
PARESTHESIA
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
18.6%
11/59 • Number of events 27 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
52.5%
31/59 • Number of events 46 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
PRESYNCOPE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Nervous system disorders
SYNCOPE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Psychiatric disorders
ANXIETY
|
15.3%
9/59 • Number of events 14 • From the date of the first dose up to 48 months.
|
|
Psychiatric disorders
DEPRESSION
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Psychiatric disorders
INSOMNIA
|
11.9%
7/59 • Number of events 9 • From the date of the first dose up to 48 months.
|
|
Psychiatric disorders
RESTLESSNESS
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Renal and urinary disorders
DYSURIA
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Renal and urinary disorders
HEMATURIA
|
5.1%
3/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Renal and urinary disorders
PROTEINURIA
|
5.1%
3/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Renal and urinary disorders
URINE DISCOLORATION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Reproductive system and breast disorders
DYSPAREUNIA
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Reproductive system and breast disorders
PREMATURE MENOPAUSE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
1.7%
1/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
39.0%
23/59 • Number of events 28 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
27.1%
16/59 • Number of events 21 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
3.4%
2/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
5.1%
3/59 • Number of events 4 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
15.3%
9/59 • Number of events 9 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
11.9%
7/59 • Number of events 17 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHEA
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
11.9%
7/59 • Number of events 8 • From the date of the first dose up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
STREP THROAT
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
DOG BITE
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.8%
4/59 • Number of events 5 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
ERYTHRODERMA
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
FACIAL ACNE
|
1.7%
1/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
HEAT RASH
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
8.5%
5/59 • Number of events 5 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
PALMARPLANTAR ERYTHRODYSESTHESIA SYNDROME
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
PLANTAR WART
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.9%
10/59 • Number of events 12 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
3.4%
2/59 • Number of events 2 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULOPAPULAR
|
28.8%
17/59 • Number of events 27 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
RASH/OISON IVY
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
SKIN INDURATION
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Skin and subcutaneous tissue disorders
SMALL LESION ON LEFT THIGH
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
|
Vascular disorders
HOT FLASHES
|
5.1%
3/59 • Number of events 3 • From the date of the first dose up to 48 months.
|
|
Vascular disorders
HYPERTENSION
|
42.4%
25/59 • Number of events 54 • From the date of the first dose up to 48 months.
|
|
Vascular disorders
HYPOTENSION
|
25.4%
15/59 • Number of events 23 • From the date of the first dose up to 48 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
1.7%
1/59 • Number of events 1 • From the date of the first dose up to 48 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place