Trial Outcomes & Findings for CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas (NCT NCT00540579)
NCT ID: NCT00540579
Last Updated: 2013-03-13
Results Overview
Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows: * Inability to Complete cycle 1 of therapy due to drug-related toxicity. * \> Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care * Febrile neutropenia (absolute neutrophil count \[ANC\] \<1,000/μL and fever \>101° F (38.5° C)) * Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT) * Platelet count \< 25,000/μL * Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity.
COMPLETED
PHASE1/PHASE2
23 participants
6 months
2013-03-13
Participant Flow
Participant milestones
| Measure |
Pomalidomide/Gemcitabine
All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
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|---|---|
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Overall Study
STARTED
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23
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
Pomalidomide/Gemcitabine
n=23 Participants
All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
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|---|---|
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Age Continuous
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62 years
n=93 Participants
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Sex: Female, Male
Female
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7 Participants
n=93 Participants
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Sex: Female, Male
Male
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16 Participants
n=93 Participants
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Region of Enrollment
United States
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23 participants
n=93 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: Two patients withdrew consent and were unevaluable for DLT. One patient suffered subdural hematoma (non-treatment related) and was unevaluable for DLT.
Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows: * Inability to Complete cycle 1 of therapy due to drug-related toxicity. * \> Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care * Febrile neutropenia (absolute neutrophil count \[ANC\] \<1,000/μL and fever \>101° F (38.5° C)) * Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT) * Platelet count \< 25,000/μL * Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity.
Outcome measures
| Measure |
Pomalidomide/Gemcitabine
n=20 Participants
All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
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Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects
Pomalidomide
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10 milligrams
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Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects
Gemcitabine
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1000 milligrams
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PRIMARY outcome
Timeframe: 24 MonthsPopulation: All patients treated with pomalidomide and gemcitabine were assessed for Grade 3/4 toxicities
The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Outcome measures
| Measure |
Pomalidomide/Gemcitabine
n=23 Participants
All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
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|---|---|
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The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0
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39 percentage of patients
Interval 19.07 to 58.93
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Adverse Events
Pomalidomide/Gemcitabine
Serious adverse events
| Measure |
Pomalidomide/Gemcitabine
n=23 participants at risk
All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
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|---|---|
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Gastrointestinal disorders
Constipation
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4.3%
1/23 • Number of events 1
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Metabolism and nutrition disorders
Hyperglycemia
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4.3%
1/23 • Number of events 1
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Respiratory, thoracic and mediastinal disorders
ARDS
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4.3%
1/23 • Number of events 1
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Gastrointestinal disorders
Perforation, GI
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4.3%
1/23 • Number of events 1
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Gastrointestinal disorders
GI - Other
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4.3%
1/23 • Number of events 1
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Gastrointestinal disorders
Obstruction - GI
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4.3%
1/23 • Number of events 1
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Blood and lymphatic system disorders
Hematoma
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4.3%
1/23 • Number of events 1
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Gastrointestinal disorders
Hemorrhage - GI
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4.3%
1/23 • Number of events 1
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General disorders
Febrile Neutropenia
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4.3%
1/23 • Number of events 1
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General disorders
Pain
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4.3%
1/23 • Number of events 1
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Infections and infestations
Infection - Pneumonia
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4.3%
1/23 • Number of events 1
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Vascular disorders
Thrombosis/Thrombus/Embolism
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17.4%
4/23 • Number of events 4
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Respiratory, thoracic and mediastinal disorders
Pneumonitis
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4.3%
1/23 • Number of events 1
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Renal and urinary disorders
Renal - Other
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4.3%
1/23 • Number of events 1
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Infections and infestations
Infection - Skin
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4.3%
1/23 • Number of events 1
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Other adverse events
| Measure |
Pomalidomide/Gemcitabine
n=23 participants at risk
All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
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|---|---|
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General disorders
Abdominal Pain
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26.1%
6/23 • Number of events 7
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Metabolism and nutrition disorders
ALT
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8.7%
2/23 • Number of events 5
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Blood and lymphatic system disorders
Hemoglobin
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52.2%
12/23 • Number of events 45
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Gastrointestinal disorders
Anorexia
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30.4%
7/23 • Number of events 7
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Musculoskeletal and connective tissue disorders
Arthralgia
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8.7%
2/23 • Number of events 3
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Gastrointestinal disorders
Ascites
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17.4%
4/23 • Number of events 5
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Metabolism and nutrition disorders
AST
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13.0%
3/23 • Number of events 4
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Cardiac disorders
Atrial Fibrillation
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8.7%
2/23 • Number of events 2
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General disorders
Back Pain
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26.1%
6/23 • Number of events 6
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Metabolism and nutrition disorders
Alkaline Phosphatase
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13.0%
3/23 • Number of events 3
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General disorders
Bone Pain
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8.7%
2/23 • Number of events 3
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General disorders
Chills
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17.4%
4/23 • Number of events 5
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Gastrointestinal disorders
Constipation
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43.5%
10/23 • Number of events 11
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Respiratory, thoracic and mediastinal disorders
Cough
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17.4%
4/23 • Number of events 4
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Gastrointestinal disorders
Dehydration
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17.4%
4/23 • Number of events 5
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Gastrointestinal disorders
Diarrhea
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39.1%
9/23 • Number of events 18
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Nervous system disorders
Dizziness
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21.7%
5/23 • Number of events 6
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Gastrointestinal disorders
Dry Mouth
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8.7%
2/23 • Number of events 2
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Gastrointestinal disorders
Dysgeusia
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8.7%
2/23 • Number of events 2
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Gastrointestinal disorders
Dyspepsia
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8.7%
2/23 • Number of events 2
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General disorders
Fatigue
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60.9%
14/23 • Number of events 20
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Gastrointestinal disorders
Flatulence
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17.4%
4/23 • Number of events 4
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Metabolism and nutrition disorders
Hyperuricemia (gout)
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8.7%
2/23 • Number of events 2
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General disorders
Headache
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13.0%
3/23 • Number of events 3
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Metabolism and nutrition disorders
Hyperglycemia
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8.7%
2/23 • Number of events 2
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General disorders
Sweating
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13.0%
3/23 • Number of events 3
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Metabolism and nutrition disorders
Hypokalemia
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13.0%
3/23 • Number of events 5
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Cardiac disorders
Hypotension
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13.0%
3/23 • Number of events 3
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Gastrointestinal disorders
Nausea
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34.8%
8/23 • Number of events 11
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Nervous system disorders
Peripheral Neuropathy
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8.7%
2/23 • Number of events 2
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Blood and lymphatic system disorders
Neutrophils
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52.2%
12/23 • Number of events 81
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General disorders
Night Sweats
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8.7%
2/23 • Number of events 2
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Blood and lymphatic system disorders
Peripheral Edema
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43.5%
10/23 • Number of events 15
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General disorders
Pain - Extremity
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13.0%
3/23 • Number of events 3
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Renal and urinary disorders
Polyuria
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8.7%
2/23 • Number of events 2
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Skin and subcutaneous tissue disorders
Pruritis
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8.7%
2/23 • Number of events 2
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Vascular disorders
Thrombus/Thrombosis/Embolism
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34.8%
8/23 • Number of events 10
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General disorders
Fever
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26.1%
6/23 • Number of events 12
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Skin and subcutaneous tissue disorders
Rash
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47.8%
11/23 • Number of events 16
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Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reaction
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8.7%
2/23 • Number of events 3
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Nervous system disorders
Syncope
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8.7%
2/23 • Number of events 2
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|
Blood and lymphatic system disorders
Platelets
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39.1%
9/23 • Number of events 20
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Eye disorders
Blurred Vision
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8.7%
2/23 • Number of events 2
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Gastrointestinal disorders
Vomiting
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30.4%
7/23 • Number of events 11
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Gastrointestinal disorders
Weight Loss
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8.7%
2/23 • Number of events 2
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER