Trial Outcomes & Findings for A Rollover Study for Patients Who Participated in Other Romidepsin Protocols (NCT NCT01353664)
NCT ID: NCT01353664
Last Updated: 2019-11-25
Results Overview
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days
Results posted on
2019-11-25
Participant Flow
This rollover study was designed to give access to Romidepsin (Romi) for participants in and then discontinued from Romi studies ROMI-ADVM-001 (NCT01324310) and ROMI-ADVM-002 (NCT01324323) who in the opinion of the investigator could have benefited from ongoing therapy with Romi; those from GPI-06-0002 did not rollover as the study did not close.
Participants started at any point during a cycle which corresponded to their previous Romi study, but continued cycle numbering where it left off from their previous participation in a Romi study
Participant milestones
| Measure |
ROMI 4
Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m\^2 or 14 mg/m\^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m\^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
ROMI 4
Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m\^2 or 14 mg/m\^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m\^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
|
|---|---|
|
Overall Study
Other
|
3
|
|
Overall Study
Disease Progression
|
16
|
Baseline Characteristics
A Rollover Study for Patients Who Participated in Other Romidepsin Protocols
Baseline characteristics by cohort
| Measure |
ROMI 4
n=19 Participants
Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m\^2 or 14 mg/m\^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m\^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
|
|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 12.69 • n=5 Participants
|
|
Age, Customized
≤ 65
|
10 Participants
n=5 Participants
|
|
Age, Customized
> 65
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (unspecified)
|
1 Participants
n=5 Participants
|
|
ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status
0 = Fully Active (Most Favorable Activity)
|
9 Participants
n=5 Participants
|
|
ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status
1 = Restricted activity but ambulatory
|
10 Participants
n=5 Participants
|
|
ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status
2 = Ambulatory; unable to carry out activities
|
0 Participants
n=5 Participants
|
|
ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status
3 = Limited Self-Care
|
0 Participants
n=5 Participants
|
|
ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status
4 = Completely Disabled
|
0 Participants
n=5 Participants
|
|
Height
|
170.4 Centimeters
STANDARD_DEVIATION 11.02 • n=5 Participants
|
|
Weight
|
75.1 Kilograms
STANDARD_DEVIATION 20.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 daysPopulation: Safety Population = Participants who received at least one dose of study drug.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.
Outcome measures
| Measure |
ROMI 4
n=19 Participants
Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m\^2 or 14 mg/m\^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m\^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
|
|---|---|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 Adverse Event (AE)
|
18 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 AE related to study drug
|
14 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 NCI CTCAE Grade 3 AE
|
11 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 NCI CTCAE Grade 4-5 AE
|
0 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 NCI CTCAE Grade 3 AE related to study drug
|
6 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 NCI CTCAE Grade 4-5 AE related to study drug
|
0 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 Serious Adverse Event (SAE)
|
6 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 SAE related to study drug
|
1 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 AE leading to discontinuation
|
1 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 AE leading to stopping the study drug
|
0 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥ 1 AE leading to dose reduction/interruption
|
7 Participants
|
|
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
≥1 AE dose reduction related to study drug
|
4 Participants
|
Adverse Events
ROMI 4
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ROMI 4
n=19 participants at risk
Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m\^2 or 14 mg/m\^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m\^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
General disorders
Fatigue
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Carcinoma of the Bladder
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Psychiatric disorders
Mental Status Changes
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
Other adverse events
| Measure |
ROMI 4
n=19 participants at risk
Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m\^2 or 14 mg/m\^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m\^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
|
|---|---|
|
General disorders
Fatigue
|
57.9%
11/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
General disorders
Asthenia
|
21.1%
4/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
General disorders
Pyrexia
|
21.1%
4/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
General disorders
Chills
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
General disorders
Non-Cardiac Chest Pain
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Constipation
|
26.3%
5/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Nausea
|
26.3%
5/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.8%
3/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
4/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.1%
4/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
10.5%
2/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.5%
2/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
26.3%
5/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Metabolism and nutrition disorders
Dehydration
|
15.8%
3/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Metabolism and nutrition disorders
Hyperlipidiaemia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Nervous system disorders
Dizziness
|
21.1%
4/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Nervous system disorders
Dysgeusia
|
10.5%
2/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Nervous system disorders
Ageusia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Nervous system disorders
Encephalopthy
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Nervous system disorders
Tremor
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Urinary Tract Infection
|
10.5%
2/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Candidiasis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Infection
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Oral Candidiasis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.5%
2/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Investigations
Weight Decreased
|
10.5%
2/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Investigations
Electrocardiogram T Wave Inversion
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Psychiatric disorders
Anxiety
|
15.8%
3/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Psychiatric disorders
Insomnia
|
10.5%
2/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Eye disorders
Eye Swelling
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Eye disorders
Lacrimation Increased
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Cardiac disorders
Sinus Tachycardia
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Endocrine disorders
Hypothyroidism
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Injury, poisoning and procedural complications
Concussion
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.3%
1/19 • All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug. Maximum time on study drug was 231 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor that restricts the PIs rights to publish trial results after the trial is completed. Upon investigator submission of a publication to Celgene, Celgene will complete its review within 60 days after receipt of the publication. Upon Celgene's request, the publication shall be delayed up to 90 additional days to enable Celgene to secure intellectual property protection that would be affected by such proposed publication.
- Publication restrictions are in place
Restriction type: OTHER