Trial Outcomes & Findings for Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma (NCT NCT03502746)
NCT ID: NCT03502746
Last Updated: 2024-05-14
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Response rate will be defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to a maximum of 23 months
Results posted on
2024-05-14
Participant Flow
Participant milestones
| Measure |
Nivolumab + Ramucirumab
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab: Nivolumab 240mg, IV over 30 minutes.
Ramucirumab: 8mg/kg, IV over 60 minutes.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma
Baseline characteristics by cohort
| Measure |
Nivolumab + Ramucirumab
n=34 Participants
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab: Nivolumab 240mg, IV over 30 minutes.
Ramucirumab: 8mg/kg, IV over 60 minutes.
|
|---|---|
|
Age, Continuous
|
72 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=99 Participants
|
|
Histology
Pleural
|
30 Participants
n=99 Participants
|
|
Histology
Peritoneal
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to a maximum of 23 monthsPopulation: Out of 34 patients, one patient was not evaluable for response after he withdrew from study because of generalized weakness one day after first infusion of ramucirumab and nivolumab.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Response rate will be defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
Outcome measures
| Measure |
Nivolumab + Ramucirumab
n=33 Participants
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab: Nivolumab 240mg, IV over 30 minutes.
Ramucirumab: 8mg/kg, IV over 60 minutes.
|
|---|---|
|
Response Rate
|
22.6 Percentage of participants
Interval 9.6 to 41.1
|
SECONDARY outcome
Timeframe: AE had been recorded from time of consent until 100 days after discontinuation of study drug or until a new anti-cancer treatment starts, whichever occurs first; up to a maximum of 28 months.The frequency and severity of all grade ≥ 2 treatment related adverse events are reported by CTCAE v4 term.
Outcome measures
| Measure |
Nivolumab + Ramucirumab
n=34 Participants
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab: Nivolumab 240mg, IV over 30 minutes.
Ramucirumab: 8mg/kg, IV over 60 minutes.
|
|---|---|
|
Adverse Event Assessment
Dyspnea
|
5 Participants
|
|
Adverse Event Assessment
Hypertension
|
3 Participants
|
|
Adverse Event Assessment
Proteinuria
|
9 Participants
|
|
Adverse Event Assessment
Arial fibrillation
|
2 Participants
|
|
Adverse Event Assessment
Abdominal Pain
|
1 Participants
|
|
Adverse Event Assessment
Anorexia
|
2 Participants
|
|
Adverse Event Assessment
Dehydration
|
1 Participants
|
|
Adverse Event Assessment
Diarrhea
|
1 Participants
|
|
Adverse Event Assessment
Dysphagia
|
1 Participants
|
|
Adverse Event Assessment
Esophageal Obstruction
|
1 Participants
|
|
Adverse Event Assessment
Fatigue
|
7 Participants
|
|
Adverse Event Assessment
Hyperkalemia
|
1 Participants
|
|
Adverse Event Assessment
Hyponatremia
|
1 Participants
|
|
Adverse Event Assessment
Muscle Weakness
|
3 Participants
|
|
Adverse Event Assessment
Non-Cardiac Chest Pain
|
1 Participants
|
|
Adverse Event Assessment
Pancreatitis
|
1 Participants
|
|
Adverse Event Assessment
Thromboembolic Event
|
1 Participants
|
|
Adverse Event Assessment
Pain
|
3 Participants
|
|
Adverse Event Assessment
Sinusitis
|
3 Participants
|
|
Adverse Event Assessment
Depression
|
2 Participants
|
|
Adverse Event Assessment
Hypothyroidism
|
2 Participants
|
|
Adverse Event Assessment
Dizziness
|
2 Participants
|
|
Adverse Event Assessment
Chest Wall Pain
|
1 Participants
|
|
Adverse Event Assessment
Cough
|
1 Participants
|
|
Adverse Event Assessment
Creatinine Increased
|
1 Participants
|
|
Adverse Event Assessment
Heart Failure
|
1 Participants
|
|
Adverse Event Assessment
Hypoxia
|
1 Participants
|
|
Adverse Event Assessment
Lower Gastrointestinal Bleed
|
1 Participants
|
|
Adverse Event Assessment
Mucositis Oral
|
1 Participants
|
|
Adverse Event Assessment
Periodontal Disease
|
1 Participants
|
|
Adverse Event Assessment
Pneumonitis
|
1 Participants
|
|
Adverse Event Assessment
Presyncope
|
1 Participants
|
|
Adverse Event Assessment
Weight loss
|
1 Participants
|
|
Adverse Event Assessment
Atopic Dermatitis
|
1 Participants
|
|
Adverse Event Assessment
Upper Respiratory Tract Infection
|
1 Participants
|
SECONDARY outcome
Timeframe: Time of treatment start until the criteria for disease progression or death, up to a maximum of 23 months.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from treatment start until disease progression met by RECIST 1.1 or death from any cause.
Outcome measures
| Measure |
Nivolumab + Ramucirumab
n=34 Participants
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab: Nivolumab 240mg, IV over 30 minutes.
Ramucirumab: 8mg/kg, IV over 60 minutes.
|
|---|---|
|
Progression-free Survival (PFS)
|
4.2 Months
Interval 1.9 to 6.4
|
SECONDARY outcome
Timeframe: Time of treatment start until death or date of last contact, up to a maximum of 32 months.Overall survival (OS) is defined as time of treatment start until death or date of last contact.
Outcome measures
| Measure |
Nivolumab + Ramucirumab
n=34 Participants
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab: Nivolumab 240mg, IV over 30 minutes.
Ramucirumab: 8mg/kg, IV over 60 minutes.
|
|---|---|
|
Overall Survival
|
12.5 Months
Interval 6.3 to 23.5
|
Adverse Events
Nivolumab + Ramucirumab
Serious events: 9 serious events
Other events: 34 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Nivolumab + Ramucirumab
n=34 participants at risk
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab: Nivolumab 240mg, IV over 30 minutes.
Ramucirumab: 8mg/kg, IV over 60 minutes.
|
|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL OBSTRUCTION
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Cardiac disorders
HEART FAILURE
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HEMORRHAGE
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
PANCREATITIS
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
Other adverse events
| Measure |
Nivolumab + Ramucirumab
n=34 participants at risk
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab: Nivolumab 240mg, IV over 30 minutes.
Ramucirumab: 8mg/kg, IV over 60 minutes.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Immune system disorders
ALLERGIC REACTION
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
2.9%
1/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
29.4%
10/34 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Psychiatric disorders
ANXIETY
|
5.9%
2/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
14.7%
5/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
8.8%
3/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.8%
4/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
11.8%
4/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
CHILLS
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Psychiatric disorders
CONFUSION
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
8.8%
3/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
32.4%
11/34 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Investigations
CREATININE INCREASED
|
8.8%
3/34 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Psychiatric disorders
DEPRESSION
|
8.8%
3/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
14.7%
5/34 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Nervous system disorders
DIZZINESS
|
11.8%
4/34 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
11.8%
4/34 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Nervous system disorders
DYSGEUSIA
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
2.9%
1/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
20.6%
7/34 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
EDEMA LIMBS
|
20.6%
7/34 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
EDEMA TRUNK
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.9%
1/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Injury, poisoning and procedural complications
FALL
|
8.8%
3/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
FATIGUE
|
55.9%
19/34 • Number of events 22 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
FEVER
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
8.8%
3/34 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
20.6%
7/34 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
GLUCOSE INTOLERANCE
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Nervous system disorders
HEADACHE
|
17.6%
6/34 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Renal and urinary disorders
HEMATURIA
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
5.9%
2/34 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
2.9%
1/34 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Vascular disorders
HYPERTENSION
|
8.8%
3/34 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
8.8%
3/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
11.8%
4/34 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
INFUSION RELATED REACTION
|
8.8%
3/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
2.9%
1/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Psychiatric disorders
INSOMNIA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
IRRITABILITY
|
2.9%
1/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS UPPER LIMB
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
11.8%
4/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
NAUSEA
|
17.6%
6/34 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
11.8%
4/34 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
General disorders
PAIN
|
29.4%
10/34 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.8%
3/34 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Cardiac disorders
PAROXYSMAL ATRIAL TACHYCARDIA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
PERIODONTAL DISEASE
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Nervous system disorders
PRESYNCOPE
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Renal and urinary disorders
PROTEINURIA
|
26.5%
9/34 • Number of events 25 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.9%
2/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
14.7%
5/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
2.9%
1/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
2.9%
1/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Infections and infestations
SINUSITIS
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
11.8%
4/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPOPIGMENTATION
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
14.7%
5/34 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
2.9%
1/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Ear and labyrinth disorders
VERTIGO
|
5.9%
2/34 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Gastrointestinal disorders
VOMITING
|
8.8%
3/34 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Eye disorders
WATERING EYES
|
2.9%
1/34 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
|
Investigations
WEIGHT LOSS
|
14.7%
5/34 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place