Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer (NCT NCT02013830)
NCT ID: NCT02013830
Last Updated: 2014-06-06
Results Overview
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Results posted on
2014-06-06
Participant Flow
Participant milestones
| Measure |
Bevacizumab/Capecitabine
A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m\^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Bevacizumab/Capecitabine
A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m\^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Insufficient therapeutic response
|
25
|
|
Overall Study
Refused treatment
|
1
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab/Capecitabine
n=45 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 14.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-upPopulation: Per Protocol (PP) Population included participants who: received greater than or equal to (≥) 1 dose of study medication, ≥6 weeks of treatment (unless excluded for allowed reasons), did not severely violate inclusion/exclusion criteria, had tumor assessment, greater than (\>) 50% of first 6 weeks of treatment, and were not replaced.
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.
Outcome measures
| Measure |
Bevacizumab/Capecitabine
n=44 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Percentage of Participants With Objective Response (OR)
|
9.1 percentage of participants
Interval 2.5 to 21.7
|
SECONDARY outcome
Timeframe: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-upPopulation: PP population.
The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.
Outcome measures
| Measure |
Bevacizumab/Capecitabine
n=44 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Percentage of Participants With Disease Control
|
52.3 percentage of participants
Interval 36.7 to 67.5
|
SECONDARY outcome
Timeframe: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-upPopulation: ITT population.
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Outcome measures
| Measure |
Bevacizumab/Capecitabine
n=44 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Time to Disease Progression - Percentage of Participants With an Event
|
77.8 percentage of participants
|
SECONDARY outcome
Timeframe: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-upPopulation: Intent-To-Treat (ITT) Population included all enrolled participants who received at least one dose of study medication.
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.
Outcome measures
| Measure |
Bevacizumab/Capecitabine
n=44 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Time to Disease Progression
|
2.8 months
Interval 1.5 to 4.1
|
SECONDARY outcome
Timeframe: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.Population: ITT population.
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Outcome measures
| Measure |
Bevacizumab/Capecitabine
n=8 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
|
24.0 percentage of participants
Interval 11.0 to 37.0
|
SECONDARY outcome
Timeframe: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.Population: ITT population.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Outcome measures
| Measure |
Bevacizumab/Capecitabine
n=44 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Overall Survival - Percentage of Participants With an Event
|
77.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.Population: ITT Population.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab/Capecitabine
n=44 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Overall Survival
|
5.9 months
Interval 4.1 to 9.7
|
SECONDARY outcome
Timeframe: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.Population: ITT population.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Outcome measures
| Measure |
Bevacizumab/Capecitabine
n=11 Participants
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Overall Survival - Percentage of Participants Event Free at 12 Months
|
27 percentage of participants
Interval 14.0 to 40.0
|
Adverse Events
Bevacizumab/Capecitabine
Serious events: 15 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab/Capecitabine
n=45 participants at risk
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Ascites
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Pyrexia
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Oedema peripheral
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Infections and infestations
Anal abscess
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Hepatitis fulminant
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Confusional state
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Dysuria
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
Other adverse events
| Measure |
Bevacizumab/Capecitabine
n=45 participants at risk
A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
12/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain
|
24.4%
11/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal distention
|
15.6%
7/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Nausea
|
15.6%
7/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
6/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
6/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Ascites
|
11.1%
5/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.9%
4/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Stomatitis
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Bowel sounds abnormal
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Haematochezia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Oedema peripheral
|
20.0%
9/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Pyrexia
|
20.0%
9/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Fatigue
|
13.3%
6/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Malaise
|
11.1%
5/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Mucosal inflammation
|
11.1%
5/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Chest discomfort
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Pain
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Chest pain
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Asthenia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Chills
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Oedema
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
General disorders
Pitting oedema
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.3%
15/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
10/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.8%
8/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
5/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
5/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Nervous system disorders
Dizziness
|
13.3%
6/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Nervous system disorders
Lethargy
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Investigations
Weight decreased
|
8.9%
4/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Investigations
Haemoglobin
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Investigations
Haemoglobin decreased
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Investigations
Platelet count decreased
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Investigations
Prostate examination abnormal
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Insomnia
|
15.6%
7/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Confusional state
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
4/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Infections and infestations
Anal abscess
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Infections and infestations
Folliculitis
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Infections and infestations
Oral candidiasis
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Dysuria
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Proteinuria
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.7%
3/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Jaundice
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Hepatobiliary disorders
Hepatitis fulminant
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Eye disorders
Dry eye
|
4.4%
2/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Eye disorders
Keratitis
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Cardiac disorders
Palpitations
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
1/45 • Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER