Trial Outcomes & Findings for Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine) (NCT NCT01845805)
NCT ID: NCT01845805
Last Updated: 2022-10-04
Results Overview
Progression free survival is defined as the time from randomization until visible recurrence on any imaging modality, a confirmed biopsy, or death. Individuals lost to follow-up prior to having an event will be censored at the time of the last scan or biopsy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
25 months
Results posted on
2022-10-04
Participant Flow
Participant milestones
| Measure |
Arm A: CC-486
CC-486 (oral azacitidine), 300 mg total, taken daily on days 1-21 (of a 28 day cycle) for up to 12 cycles. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
Arm B: Observation
Observation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
| Measure |
Arm A: CC-486
CC-486 (oral azacitidine), 300 mg total, taken daily on days 1-21 (of a 28 day cycle) for up to 12 cycles. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
Arm B: Observation
Observation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Disease Progression
|
13
|
14
|
|
Overall Study
Drug-related Toxicity
|
4
|
0
|
Baseline Characteristics
Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine)
Baseline characteristics by cohort
| Measure |
Arm A: CC-486
n=24 Participants
CC-486 (oral azacitidine), 300 mg total, taken daily on days 1-21 (of a 28 day cycle) for up to 12 cycles. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
Arm B: Observation
n=25 Participants
Observation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 25 monthsPopulation: Only 23/24 were evaluable for this outcome in Arm A
Progression free survival is defined as the time from randomization until visible recurrence on any imaging modality, a confirmed biopsy, or death. Individuals lost to follow-up prior to having an event will be censored at the time of the last scan or biopsy.
Outcome measures
| Measure |
Arm A: CC-486
n=23 Participants
CC-486 (oral azacitidine), 300 mg total, taken daily on days 1-21 (of a 28 day cycle) for up to 12 cycles. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
Arm B: Observation
n=25 Participants
Observation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
|---|---|---|
|
Progression-free Survival
|
9.2 months
Interval 4.1 to 20.9
|
8.9 months
Interval 3.4 to 24.6
|
SECONDARY outcome
Timeframe: 11 monthsPopulation: Evaluable participants for this outcome include participants with recurrence post-treatment with CC-486 who went on to receive first line chemotherapy and completed a follow-up scan that was available for review. Only 13/24 in Arm A and 13/25 in Arm B were evaluable for this outcome.
Response rate (partial response or complete response) to first-line chemotherapy when given after visible disease recurrence in patients primed with CC-486 compared to observation. Partial and complete responses were assessed by standard of care radiology reads and documented scan interpretations.
Outcome measures
| Measure |
Arm A: CC-486
n=13 Participants
CC-486 (oral azacitidine), 300 mg total, taken daily on days 1-21 (of a 28 day cycle) for up to 12 cycles. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
Arm B: Observation
n=13 Participants
Observation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
|---|---|---|
|
Response Rate as Assessed by Number of Participants With Partial or Complete Response
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 47 monthsOverall survival is defined as the time from randomization until death. Individuals lost to follow-up prior to death will be censored at the time of last physician contact.
Outcome measures
| Measure |
Arm A: CC-486
n=24 Participants
CC-486 (oral azacitidine), 300 mg total, taken daily on days 1-21 (of a 28 day cycle) for up to 12 cycles. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
Arm B: Observation
n=25 Participants
Observation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
|---|---|---|
|
Overall Survival
|
33.8 months
Interval 12.8 to 47.6
|
26.4 months
Interval 17.8 to 46.7
|
Adverse Events
Arm A: CC-486
Serious events: 0 serious events
Other events: 23 other events
Deaths: 15 deaths
Arm B: Observation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: CC-486
n=23 participants at risk
CC-486 (oral azacitidine), 300 mg total, taken daily on days 1-21 (of a 28 day cycle) for up to 12 cycles. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
Arm B: Observation
Observation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.
|
|---|---|---|
|
Investigations
Weight Loss
|
21.7%
5/23 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
General disorders
Fatigue
|
60.9%
14/23 • Number of events 19 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Bloating
|
13.0%
3/23 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
43.5%
10/23 • Number of events 15 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
56.5%
13/23 • Number of events 21 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Vomting
|
13.0%
3/23 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
21.7%
5/23 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Investigations
Lymphocyte count decreased
|
4.3%
1/23 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Investigations
Neutrophil count decreased
|
21.7%
5/23 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Anorexia
|
30.4%
7/23 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
1/23 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Infections and infestations
Oral abscess
|
4.3%
1/23 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
1/23 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
13.0%
3/23 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
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General disorders
Fever
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4.3%
1/23 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
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Musculoskeletal and connective tissue disorders
Muscle cramps
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4.3%
1/23 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
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Investigations
Platelet count decreased
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4.3%
1/23 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
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Investigations
White blood cell count decreased
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26.1%
6/23 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 12 months. All-cause mortality was evaluated for up to 47 months.
Only 23/24 participants in Arm A were assessed for Serious and Other (Not Including Serious) Adverse Events. Arm B (Observation) patients did not receive any treatment; therefore Serious and Other (Not Including Serious) Adverse Events were not collected. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the 12 month time frame of treatment and the assessment of adverse events.
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Additional Information
Nilofer Azad, MD
Sidney Kimmel Cancer Center at Johns Hopkins
Phone: 410-614-9169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place