Trial Outcomes & Findings for A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum. (NCT NCT01169558)

Last Updated: 2016-12-08

Results Overview

A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

168 participants

Primary outcome timeframe

Up to approximately 3 years

Results posted on

2016-12-08

Participant Flow

168 participants were enrolled in the study of which 162 received at least one dose of study drug. Only those who received at least one dose of study medication were included in the Intent to Treat (ITT) population, which is the population reported.

Participant milestones

Participant milestones
Measure	Bevacizumab Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Overall Study STARTED	162
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	156

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Overall Study Disease progression	98
Overall Study Adverse Event	25
Overall Study Withdrawal of Consent	8
Overall Study Medical Decision	7
Overall Study Stable Disease	4
Overall Study Lost to Follow-up	4
Overall Study Need for Surgery	4
Overall Study Non-compliance	2
Overall Study Protocol Violation	2
Overall Study Partial response	2

Baseline Characteristics

A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab n=162 Participants Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Age, Continuous	55.9 years STANDARD_DEVIATION 13.1 • n=5 Participants
Gender Female	89 Participants n=5 Participants
Gender Male	73 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 3 years

Population: The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.

Outcome measures

Outcome measures
Measure	Bevacizumab n=162 Participants Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Safety: Number of Participants With Serious and Specific Adverse Events Serious Adverse Events	50 participants
Safety: Number of Participants With Serious and Specific Adverse Events Spec AEs: Hypertension	57 participants
Safety: Number of Participants With Serious and Specific Adverse Events Spec AEs: Bleeding/hemorrhage	42 participants
Safety: Number of Participants With Serious and Specific Adverse Events Spec AEs: Proteinuria	22 participants
Safety: Number of Participants With Serious and Specific Adverse Events Spec AEs:Wound healing complications	6 participants
Safety: Number of Participants With Serious and Specific Adverse Events Spec AEs: Thrombosis/thrombus/embolism	5 participants
Safety: Number of Participants With Serious and Specific Adverse Events Spec AEs: T/t/e - Vascular Access	2 participants
Safety: Number of Participants With Serious and Specific Adverse Events Spec AEs: Gastrointestinal perforation	2 participants
Safety: Number of Participants With Serious and Specific Adverse Events Spec AEs: Infusion (injection) Site Reaction	2 participants

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: 158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.

Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival.

Outcome measures

Outcome measures
Measure	Bevacizumab n=158 Participants Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Efficacy: Overall Survival	21.6 months Interval 18.3 to 25.5

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: 158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.

Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 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. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression.

Outcome measures

Outcome measures
Measure	Bevacizumab n=158 Participants Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Efficacy: Time to Disease Progression	11.4 months Interval 9.5 to 13.9

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: 158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.

Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 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. Reported is the median time of PFS.

Outcome measures

Outcome measures
Measure	Bevacizumab n=158 Participants Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Efficacy: Progression-free Survival	11.0 months Interval 9.5 to 13.9

Adverse Events

Bevacizumab

Serious events: 50 serious events

Other events: 153 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab n=162 participants at risk Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Gastrointestinal disorders Diarrhoea	3.7% 6/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Abdominal pain	1.9% 3/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Vomiting	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Anal fistula	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Ascites	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Gastrointestinal pain	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Intestinal fistula	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Intestinal obstruction	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Intestinal perforation	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Large intestinal haemorrhage	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Blood and lymphatic system disorders Febrile neutropenia	3.1% 5/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Blood and lymphatic system disorders Neutropenia	1.9% 3/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Blood and lymphatic system disorders Bone marrow failure	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Vascular disorders Deep vein thrombosis	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Vascular disorders Hypertension	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Vascular disorders Haemorrhage	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Vascular disorders Hypotension	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Vascular disorders Venous thrombosis	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Infection	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Abdominal wall abscess	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Cystitis	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Device related infection	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Genitourinary tract infection	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Pharyngitis	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Pneumonia	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Pyelonephritis	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Sepsis	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Tonsillitis	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Metabolism and nutrition disorders Dehydration	2.5% 4/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Metabolism and nutrition disorders Cachexia	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Metabolism and nutrition disorders Hyperglycaemia	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Metabolism and nutrition disorders Hypokalaemia	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Metabolism and nutrition disorders Tumour lysis syndrome	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
General disorders Pyrexia	1.9% 3/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
General disorders Mucosal inflammation	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
General disorders Asthenia	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
General disorders Disease progression	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Nervous system disorders Seizure	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Nervous system disorders Cerebrovascular accident	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Nervous system disorders Dysarthria	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Nervous system disorders Loss of consciousness	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Nervous system disorders Neurological symptom	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Renal and urinary disorders Hydronephrosis	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Renal and urinary disorders Renal colic	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Renal and urinary disorders Vesical fistula	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Cardiac disorders Angina pectoris	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Immune system disorders Immunodeficiency	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Injury, poisoning and procedural complications Vascular access complication	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Reproductive system and breast disorders Vaginal fistula	0.62% 1/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Vascular disorders Thrombosis	1.2% 2/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.

Other adverse events

Other adverse events
Measure	Bevacizumab n=162 participants at risk Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Gastrointestinal disorders Diarrhoea	49.4% 80/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Nausea	46.3% 75/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Abdominal pain	31.5% 51/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Vomiting	29.6% 48/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Stomatitis	25.9% 42/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Constipation	11.1% 18/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Gastrointestinal disorders Rectal haemorrhage	5.6% 9/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
General disorders Fatigue	40.1% 65/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
General disorders Pyrexia	14.8% 24/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
General disorders Influenza like illness	6.8% 11/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
General disorders Oedema peripheral	5.6% 9/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Vascular disorders Hypertension	35.2% 57/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Nervous system disorders Peripheral sensory neuropathy	25.9% 42/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Nervous system disorders Headache	9.3% 15/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Nervous system disorders Dizziness	7.4% 12/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Renal and urinary disorders Proteinuria	29.6% 48/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Metabolism and nutrition disorders Decreased appetite	24.1% 39/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Metabolism and nutrition disorders Dehydration	8.0% 13/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Skin and subcutaneous tissue disorders Rash	17.3% 28/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Skin and subcutaneous tissue disorders Alopecia	11.7% 19/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 27/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 11/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Musculoskeletal and connective tissue disorders Back pain	11.1% 18/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Musculoskeletal and connective tissue disorders Pain in extremity	9.3% 15/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Investigations Weight decreased	11.7% 19/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Investigations Weight increased	8.0% 13/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Infections and infestations Upper respiratory tract infection	7.4% 12/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
Psychiatric disorders Depression	7.4% 12/162 • Up to approximately 3 years The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

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 that 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