Trial Outcomes & Findings for Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery (NCT NCT00101036)
NCT ID: NCT00101036
Last Updated: 2018-04-20
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2018-04-20
Participant Flow
Participant milestones
| Measure |
Arm 1
GW572016 1500 mg orally daily for 28 days, Biliary strata
|
Arm 2
GW572016 1500 mg orally daily for 28 days, HCC strata
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
40
|
|
Overall Study
COMPLETED
|
17
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Arm 1
n=17 Participants
GW572016 1500 mg orally daily for 28 days, Biliary strata
|
Arm 2
n=40 Participants
GW572016 1500 mg orally daily for 28 days, HCC strata
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
40 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Arm 1
n=17 Participants
GW572016 1500 mg orally daily for 28 days, Biliary strata
|
Arm 2
n=40 Participants
GW572016 1500 mg orally daily for 28 days, HCC strata
|
|---|---|---|
|
Response Rate
|
0 percentage of responding patients
|
5 percentage of responding patients
|
SECONDARY outcome
Timeframe: Up to 5 yearsEstimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Arm 1
n=17 Participants
GW572016 1500 mg orally daily for 28 days, Biliary strata
|
Arm 2
n=40 Participants
GW572016 1500 mg orally daily for 28 days, HCC strata
|
|---|---|---|
|
Overall Survival
|
5.2 Months
Interval 3.3 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
6.2 Months
Interval 5.1 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Up to 5 yearsEstimated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm 1
n=17 Participants
GW572016 1500 mg orally daily for 28 days, Biliary strata
|
Arm 2
n=40 Participants
GW572016 1500 mg orally daily for 28 days, HCC strata
|
|---|---|---|
|
Progression-free Survival
|
1.8 Months
Interval 1.7 to 5.2
|
2.3 Months
Interval 1.7 to 5.6
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe mathematical sum of percentages of complete response, partial response and stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Outcome measures
| Measure |
Arm 1
n=17 Participants
GW572016 1500 mg orally daily for 28 days, Biliary strata
|
Arm 2
n=40 Participants
GW572016 1500 mg orally daily for 28 days, HCC strata
|
|---|---|---|
|
Disease Control Rate.
|
26 percentage of participants
|
5 percentage of participants
|
Adverse Events
Arm 1
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Arm 2
Serious events: 13 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=17 participants at risk
GW572016 1500 mg orally daily for 28 days, Biliary strata
|
Arm 2
n=40 participants at risk
GW572016 1500 mg orally daily for 28 days, HCC strata
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Chest pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Death
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Disease progression
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
10.0%
4/40 • Number of events 4 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Infections and infestations
Bone infection
|
5.9%
1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Infections and infestations
Infection
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Hyperbilirubinemia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Vascular disorders
Thrombosis
|
11.8%
2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
Other adverse events
| Measure |
Arm 1
n=17 participants at risk
GW572016 1500 mg orally daily for 28 days, Biliary strata
|
Arm 2
n=40 participants at risk
GW572016 1500 mg orally daily for 28 days, HCC strata
|
|---|---|---|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
35.3%
6/17 • Number of events 9 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
50.0%
20/40 • Number of events 67 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Eye disorders
Vision blurred
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 9 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.5%
4/17 • Number of events 8 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
37.5%
15/40 • Number of events 25 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17 • Number of events 5 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
22.5%
9/40 • Number of events 10 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
10/17 • Number of events 12 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
65.0%
26/40 • Number of events 58 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
7.5%
3/40 • Number of events 5 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
15.0%
6/40 • Number of events 17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Mucositis oral
|
11.8%
2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
10.0%
4/40 • Number of events 7 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17 • Number of events 23 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
50.0%
20/40 • Number of events 32 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • Number of events 8 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
22.5%
9/40 • Number of events 11 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Chest pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Disease progression
|
82.4%
14/17 • Number of events 14 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
55.0%
22/40 • Number of events 22 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Edema limbs
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
12.5%
5/40 • Number of events 8 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Fatigue
|
70.6%
12/17 • Number of events 21 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
67.5%
27/40 • Number of events 68 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Fever
|
11.8%
2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
General symptom
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
General disorders
Pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
7.5%
3/40 • Number of events 4 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Alanine aminotransferase increased
|
23.5%
4/17 • Number of events 6 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
45.0%
18/40 • Number of events 46 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Alkaline phosphatase increased
|
52.9%
9/17 • Number of events 15 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
45.0%
18/40 • Number of events 44 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Amylase increased
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Aspartate aminotransferase increased
|
29.4%
5/17 • Number of events 8 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
65.0%
26/40 • Number of events 91 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Creatinine increased
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
12.5%
5/40 • Number of events 8 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Hyperbilirubinemia
|
41.2%
7/17 • Number of events 9 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
37.5%
15/40 • Number of events 40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
INR increased
|
5.9%
1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
10.0%
4/40 • Number of events 6 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Leukopenia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
12.5%
5/40 • Number of events 18 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Lipase increased
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Lymphopenia
|
11.8%
2/17 • Number of events 4 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
17.5%
7/40 • Number of events 13 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
12.5%
5/40 • Number of events 7 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Platelet count decreased
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
30.0%
12/40 • Number of events 42 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Investigations
Weight loss
|
17.6%
3/17 • Number of events 4 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
17.5%
7/40 • Number of events 8 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Anorexia
|
29.4%
5/17 • Number of events 11 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
40.0%
16/40 • Number of events 23 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
10.0%
4/40 • Number of events 5 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.1%
8/17 • Number of events 17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
50.0%
20/40 • Number of events 50 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
35.3%
6/17 • Number of events 8 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
37.5%
15/40 • Number of events 31 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.8%
2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
10.0%
4/40 • Number of events 8 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.5%
4/17 • Number of events 5 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
7.5%
3/40 • Number of events 7 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.5%
4/17 • Number of events 6 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
30.0%
12/40 • Number of events 20 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
10.0%
4/40 • Number of events 5 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 4 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.9%
1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
12.5%
5/40 • Number of events 6 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Nervous system disorders
Taste alteration
|
11.8%
2/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
15.0%
6/40 • Number of events 9 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
17.5%
7/40 • Number of events 10 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Renal and urinary disorders
Kidney pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Renal and urinary disorders
Proteinuria
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
0.00%
0/40 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
7.5%
3/40 • Number of events 10 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
5.9%
1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngoscopy abnormal
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.8%
2/17 • Number of events 5 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
22.5%
9/40 • Number of events 24 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
12.5%
5/40 • Number of events 10 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
25.0%
10/40 • Number of events 16 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
29.4%
5/17 • Number of events 5 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
30.0%
12/40 • Number of events 37 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.9%
1/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
7.5%
3/40 • Number of events 17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
|
Vascular disorders
Hypotension
|
0.00%
0/17 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over a period of 2 years, 3 months.
"Other" adverse events include all grades and attribution to treatment that are not included in the "Serious" adverse events table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60