Trial Outcomes & Findings for Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma (NCT NCT00717522)
NCT ID: NCT00717522
Last Updated: 2019-11-19
Results Overview
An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject's health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
Pomalidomide
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Pomalidomide
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
|
|---|---|
|
Overall Study
Disease Progression
|
5
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Pomalidomide
n=7 Participants
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
|
|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).Population: All participants
An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject's health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.
Outcome measures
| Measure |
Pomalidomide
n=7 Participants
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
|
|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
≥1 AE
|
7 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
≥1 AE suspected to be related to study drug
|
6 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
≥1 Grade 3 AE
|
4 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
≥1 Grade 4 AE
|
1 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
≥1 SAE
|
3 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
≥1 SAE suspected to be related to study drug
|
1 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
Death
|
4 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
Death within 30 days of last dose of study drug
|
1 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
Discontinuation due to AE
|
2 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
Dose reduction and interruption due to AE
|
1 participants
|
SECONDARY outcome
Timeframe: Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).Population: This analysis was not done. Study enrollment was suspended due to a corporate strategic decision unrelated to patient safety, and the protocol was amended to evaluate safety only (efficacy data was stored but not cleaned or analyzed unless related to safety).
Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.
Outcome measures
Outcome data not reported
Adverse Events
Pomalidomide
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pomalidomide
n=7 participants at risk
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma Metastatic
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Malnutrition
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
Other adverse events
| Measure |
Pomalidomide
n=7 participants at risk
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Palatal disorder
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Tongue disorder
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
General disorders
Fatigue
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
General disorders
Asthenia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
General disorders
Chills
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
General disorders
Malaise
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
General disorders
Pain
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Blood and lymphatic system disorders
Anaemia
|
42.9%
3/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Investigations
Ammonia increased
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Investigations
Blood lactate dehydrogenase increased
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Investigations
Electrocardiogram q waves
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Investigations
International normalised ratio increased
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Investigations
Weight decreased
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Nervous system disorders
Lethargy
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Nervous system disorders
Vocal cord paralysis
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Cachexia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Hypophagia
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Metabolism and nutrition disorders
Malnutrition
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Psychiatric disorders
Libido decreased
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Psychiatric disorders
Personality change
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Immune system disorders
Hypersensitivity
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
|
Additional Information
Associate Director, Clinical Trial Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER