Trial Outcomes & Findings for ChemoRT With Adjuvant Chemo in Pancreatic Cancer (TARCEVA) (NCT NCT00313560)
NCT ID: NCT00313560
Last Updated: 2020-06-04
Results Overview
Time from surgery to recurrence
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2020-06-04
Participant Flow
All patients enrolled at Johns Hopkins
Participant milestones
| Measure |
Erlotinib and EBRT After Pancreatectomy
Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ChemoRT With Adjuvant Chemo in Pancreatic Cancer (TARCEVA)
Baseline characteristics by cohort
| Measure |
Erlotinib and EBRT After Pancreatectomy
n=48 Participants
All patients received RT, Erlotinib and Capecitabine, followed by gemcitabine/erlotinib
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsTime from surgery to recurrence
Outcome measures
| Measure |
Erlotinib and EBRT After Pancreatectomy
n=48 Participants
Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine, followed by adjuvant chemotherapy with gemcitabine/erlotinib.
|
Adjuvant Gemcitabine Plus Erlotinib
Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.
|
|---|---|---|
|
Recurrence Free Survival
|
15.6 months
Interval 13.4 to 17.9
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: 39/48 total participants received maintenance chemotherapy after chemoradiation.
Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile.
Outcome measures
| Measure |
Erlotinib and EBRT After Pancreatectomy
n=48 Participants
Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine, followed by adjuvant chemotherapy with gemcitabine/erlotinib.
|
Adjuvant Gemcitabine Plus Erlotinib
n=39 Participants
Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events
Grade 3
|
15 Participants
|
14 Participants
|
|
Number of Participants Experiencing Adverse Events
Grade 2
|
24 Participants
|
15 Participants
|
|
Number of Participants Experiencing Adverse Events
Grade 4
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 months after completion of maintenance chemotherapyPopulation: QoL data was only available for 33 participants. Paired data for time 1 was only available for 30/33 participants, and only 20/33 participants at time 2.
Quality of life (QOL) was assessed before chemoradiation therapy (CRT) was started or during the first week of its administration \[baseline (BL)\], between completion of CRT and starting maintenance chemotherapy \[time 1 (t1)\], and within 3 months after completion of maintenance chemotherapy \[time 2 (t2)\]. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assesses quality of life on three domains: symptoms (score ranges from 7-14); function (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes.
Outcome measures
| Measure |
Erlotinib and EBRT After Pancreatectomy
n=33 Participants
Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine, followed by adjuvant chemotherapy with gemcitabine/erlotinib.
|
Adjuvant Gemcitabine Plus Erlotinib
Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.
|
|---|---|---|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
Global (Time 1 vs. BL)
|
1 score on a scale
Interval -6.5 to 8.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
Global (Time 2 vs. BL)
|
-1.8 score on a scale
Interval -8.1 to 4.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
Global (Time 2 vs. Time 1)
|
4.6 score on a scale
Interval -3.3 to 12.6
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
Functional (F) - Physical (Time 1 vs. BL)
|
0.5 score on a scale
Interval -4.8 to 5.8
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Physical (Time 2 vs. BL)
|
-3.2 score on a scale
Interval -8.8 to 2.3
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Physical (Time 2 vs. Time 1)
|
-6.2 score on a scale
Interval -11.0 to 1.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Role (Time 1 vs. BL)
|
-3.1 score on a scale
Interval -13.5 to 7.2
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Role (Time 2 vs. BL)
|
-0.3 score on a scale
Interval -13.5 to 12.9
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Role (Time 2 vs. Time 1)
|
-4.4 score on a scale
Interval -15.5 to 6.7
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Cognition (Time 1 vs. BL)
|
-2.6 score on a scale
Interval -7.4 to 2.2
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Cognition (Time 2 vs. BL)
|
1.2 score on a scale
Interval -6.6 to 9.1
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Cognition (Time 2 vs. Time 1)
|
-1.2 score on a scale
Interval -8.3 to 5.8
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Emotional (Time 1 vs. BL)
|
-0.4 score on a scale
Interval -5.3 to 4.4
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Emotional (Time 2 vs. BL)
|
2.2 score on a scale
Interval -5.2 to 9.6
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Emotional (Time 2 vs. Time 1)
|
-0.6 score on a scale
Interval -9.1 to 7.9
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Social (Time 1 vs. BL)
|
3.9 score on a scale
Interval -5.4 to 13.1
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Social (Time 2 vs. BL)
|
4.4 score on a scale
Interval -5.7 to 14.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
F - Social (Time 2 vs. Time 1)
|
-3.8 score on a scale
Interval -14.2 to 6.7
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
Financial (Time 1 vs. BL)
|
1.7 score on a scale
Interval -4.3 to 7.6
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
Financial (Time 2 vs. BL)
|
2.5 score on a scale
Interval -2.7 to 7.7
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
Financial (Time 2 vs. Time 1)
|
0 score on a scale
Interval -7.6 to 7.6
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
General Symptoms (GS) - Fatigue (Time 1 vs. BL)
|
5.7 score on a scale
Interval -1.1 to 12.4
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Fatigue (Time 2 vs. BL)
|
5.2 score on a scale
Interval -2.1 to 12.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Fatigue (Time 2 vs. Time 1)
|
1.7 score on a scale
Interval -6.2 to 9.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Nausea/Vomiting (Time 1 vs. BL)
|
2.5 score on a scale
Interval -2.9 to 7.9
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Nausea/Vomiting (Time 2 vs. BL)
|
0 score on a scale
Interval -7.4 to 7.4
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Nausea/Vomiting (Time 2 vs. Time 1)
|
1.9 score on a scale
Interval -5.3 to 9.0
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Pain (Time 1 vs. BL)
|
2.7 score on a scale
Interval -4.9 to 10.3
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Pain (Time 2 vs. BL)
|
7.2 score on a scale
Interval -2.0 to 16.4
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Pain (Time 2 vs. Time 1)
|
5 score on a scale
Interval -4.0 to 14.0
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Dyspnea (Time 1 vs. BL)
|
1.7 score on a scale
Interval 1.7 to 5.1
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Dyspnea Time 2 vs. BL)
|
3.8 score on a scale
Interval -5.0 to 12.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Dyspnea (Time 2 vs. Time 1)
|
1.2 score on a scale
Interval -7.6 to 10.1
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Insomnia (Time 1 vs. BL)
|
-2.5 score on a scale
Interval -9.6 to 4.6
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Insomnia (Time 2 vs. BL)
|
0 score on a scale
Interval -13.2 to 13.2
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Insomnia (Time 2 vs. Time 1)
|
2.5 score on a scale
Interval -8.8 to 13.8
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Appetite Loss (Time 1 vs. BL)
|
-2.5 score on a scale
Interval -11.5 to 6.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Appetite Loss (Time 2 vs. BL)
|
-15 score on a scale
Interval -28.9 to 1.1
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Appetite Loss (Time 2 vs. Time 1)
|
-5 score on a scale
Interval -18.5 to 8.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Constipation (Time 1 vs. BL)
|
-4.2 score on a scale
Interval -10.7 to 2.4
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Constipation (Time 2 vs. BL)
|
-2.5 score on a scale
Interval -7.7 to 2.7
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Constipation (Time 2 vs. Time 1)
|
0 score on a scale
Interval -5.4 to 5.4
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Diarrhea (Time 1 vs. BL)
|
14.7 score on a scale
Interval 6.8 to 22.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Diarrhea (Time 2 vs. BL)
|
8.8 score on a scale
Interval 0.0 to 17.5
|
—
|
|
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
GS - Diarrhea (Time 2 vs. Time 1)
|
-6.2 score on a scale
Interval -16.9 to 4.4
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: QoL data was only available for 33 participants. Paired data for time 1 was only available for 30/33 participants, and only 20/33 participants at time 2.
Quality of life (QOL) was assessed before CRT was started or during the first week of its administration (baseline \[BL\]), between completion of CRT and starting maintenance chemotherapy (time 1 \[t1\]), and within 3 months after completion of maintenance chemotherapy (time 2 \[t2\]). QLQ-PAN 26 questionnaire includes 26 questions, organized into 7 scales, with scores for each ranging from 0-100. Higher scores indicate worse health state. Therefore, decreasing (negative) scores indicate a better outcome.
Outcome measures
| Measure |
Erlotinib and EBRT After Pancreatectomy
n=33 Participants
Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine, followed by adjuvant chemotherapy with gemcitabine/erlotinib.
|
Adjuvant Gemcitabine Plus Erlotinib
Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.
|
|---|---|---|
|
Change in QoL as Assessed by QLQ-PAN 26
Pancreatic Pain (t1 vs. BL)
|
-1.9 score on a scale
Interval -6.8 to 3.0
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Pancreatic Pain (t2 vs. BL)
|
-3.8 score on a scale
Interval -11.7 to 4.1
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Pancreatic Pain (t2 vs. t1)
|
2.4 score on a scale
Interval -4.3 to 9.2
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Digestive (t1 vs. BL)
|
-0.9 score on a scale
Interval -9.1 to 7.3
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Digestive (t2 vs. BL)
|
-4.6 score on a scale
Interval -13.6 to 4.4
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Digestive (t2 vs. t1)
|
-1.4 score on a scale
Interval -7.4 to 4.6
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Altered Bowel Habits (t1 vs. BL)
|
14.7 score on a scale
Interval 6.0 to 23.5
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Altered Bowel Habits (t2 vs. BL)
|
7.2 score on a scale
Interval -2.7 to 17.1
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Altered Bowel Habits (t2 vs. t1)
|
-4.9 score on a scale
Interval -12.0 to 2.3
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Jaundice (t1 vs. BL)
|
-1.3 score on a scale
Interval -6.7 to 4.0
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Jaundice (t2 vs. BL)
|
-2 score on a scale
Interval -12.1 to 8.1
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Jaundice (t2 vs. t1)
|
0 score on a scale
Interval -5.2 to 5.2
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Body Image (t1 vs. BL)
|
-6.2 score on a scale
Interval -13.2 to 0.7
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Body Image (t2 vs. BL)
|
-3.1 score on a scale
Interval -10.7 to 4.4
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Body Image (t2 vs. t1)
|
-0.7 score on a scale
Interval -10.2 to 8.9
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Satisfaction with healthcare (t1 vs. BL)
|
4.1 score on a scale
Interval -5.8 to 13.9
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Satisfaction with health care (t2 vs. BL)
|
3.1 score on a scale
Interval -12.3 to 18.5
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Satisfaction with health care (t2 vs. t1)
|
0 score on a scale
Interval -11.4 to 11.4
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Sexual function (t1 vs. BL)
|
-0.5 score on a scale
Interval -10.8 to 9.7
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Sexual function (t2 vs. BL)
|
14.7 score on a scale
Interval 2.6 to 26.8
|
—
|
|
Change in QoL as Assessed by QLQ-PAN 26
Sexual function (t2 vs. t1)
|
14.1 score on a scale
Interval 3.0 to 25.2
|
—
|
SECONDARY outcome
Timeframe: up to 5 yearsOutcome measures
| Measure |
Erlotinib and EBRT After Pancreatectomy
n=48 Participants
Patients received intensity modulated radiation therapy given concurrently with erlotinib and capecitabine, followed by adjuvant chemotherapy with gemcitabine/erlotinib.
|
Adjuvant Gemcitabine Plus Erlotinib
Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.
|
|---|---|---|
|
Time to Death as Assessed by Median Overall Survival (Months)
|
24.39 months
Interval 18.87 to 29.65
|
—
|
Adverse Events
Erlotinib and EBRT After Prostatectomy
Serious events: 16 serious events
Other events: 31 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Erlotinib and EBRT After Prostatectomy
n=48 participants at risk
Patients receive oral erlotinib hydrochloride once a day for 3-5 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given orally
|
|---|---|
|
General disorders
Fever
|
8.3%
4/48 • Adverse Event data was collected for approximately 3 years.
|
|
Blood and lymphatic system disorders
Gastrointestinal bleeding
|
6.2%
3/48 • Adverse Event data was collected for approximately 3 years.
|
|
Psychiatric disorders
Altered Mental Status
|
4.2%
2/48 • Adverse Event data was collected for approximately 3 years.
|
|
Nervous system disorders
Syncope
|
4.2%
2/48 • Adverse Event data was collected for approximately 3 years.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
4.2%
2/48 • Adverse Event data was collected for approximately 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
2/48 • Adverse Event data was collected for approximately 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
2/48 • Adverse Event data was collected for approximately 3 years.
|
|
Gastrointestinal disorders
Enteritis
|
4.2%
2/48 • Adverse Event data was collected for approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.2%
2/48 • Adverse Event data was collected for approximately 3 years.
|
|
Gastrointestinal disorders
Intractable nausea/vomiting
|
2.1%
1/48 • Adverse Event data was collected for approximately 3 years.
|
Other adverse events
| Measure |
Erlotinib and EBRT After Prostatectomy
n=48 participants at risk
Patients receive oral erlotinib hydrochloride once a day for 3-5 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given orally
|
|---|---|
|
Blood and lymphatic system disorders
Elevated AST/elevated ALT
|
25.0%
12/48 • Adverse Event data was collected for approximately 3 years.
|
|
Blood and lymphatic system disorders
Elevated ALP
|
14.6%
7/48 • Adverse Event data was collected for approximately 3 years.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
8.3%
4/48 • Adverse Event data was collected for approximately 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
3/48 • Adverse Event data was collected for approximately 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
39.6%
19/48 • Adverse Event data was collected for approximately 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
8/48 • Adverse Event data was collected for approximately 3 years.
|
|
General disorders
Nausea
|
64.6%
31/48 • Adverse Event data was collected for approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
58.3%
28/48 • Adverse Event data was collected for approximately 3 years.
|
|
General disorders
Anorexia
|
62.5%
30/48 • Adverse Event data was collected for approximately 3 years.
|
|
General disorders
Fatigue
|
60.4%
29/48 • Adverse Event data was collected for approximately 3 years.
|
|
General disorders
Weight loss
|
60.4%
29/48 • Adverse Event data was collected for approximately 3 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.8%
10/48 • Adverse Event data was collected for approximately 3 years.
|
Additional Information
Dr. Amol Narang
Sidney Kimmel Comprehensive Cancer Center
Phone: 410-502-3823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place